Surgical Scarring Reduced By Biodegradable Film
Time For A Check Up...Of Your Insurance Coverage
Tranzyme Pharma Receives IND Clearance For Its Oral Ghrelin Agonist, TZP-102, For The Treatment Of Gastroparesis
Fatal Infections In Critically Ill Patients May Be Caused By Cosmetic Products
New Class Of Highly Selective 5-HT4 Receptor Agonists Provides The Next Generation Of GI Treatments
Fatalistic Beliefs And Unethical Behavior
The World's First 'Operation' Gown
Overrule Your Budget Office, Mr. President - By Newt Gingrich And David Merritt, USA
CSCI Report Shows Glaring Inconsistencies In Care And Support For Vulnerable Adults That Must Be Addressed, Says King's Fund, UK
Gastric Surgery Link To Diabetes Treatment, UK
Radius Announces Launch Of RAD1901 Clinical Program For The Treatment Of Hot Flashes
Study Analyzes Best Approach For Treating Abdominal Aortic Aneurysms
Study Showing Differences In Access To Pain Treatment Illustrates Overall Issue Of Health Disparities, Opinion Piece Says
Tiller Attorneys Ask Kan. Court To Block Subpoenas For Records Of 2,000 Women Who Sought Abortions
A Concept For Cost-Benefit Assessment Methods In The German Health Care System
Research Into Inflamation, Sensory Neurons And Low Back Pain Receives $1.7 Million
BioLineRx Presents Pre-Clinical Data Demonstrating That BL-1021 Is Safe And Effective In Treating Neuropathic Pain
Tips For Dry Winter Skin, From The Harvard Health Letter
Antidepressants Unproven As Treatment For Low Back Pain
Thursday, January 31, 2008
Prevention of adhesion formation following ovarian surgery in a standardized animal model: Comparative study of Interceed and double layer Surgicell.
Ates U, Ata B, Ortakuz S, Seyhan A, Urman B.
Vakif Gureba Training Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey.
Aim: Comparison of antiadhesive performances of double layer Surgicell and single layer Interceed following ovarian surgery in a rabbit model. Methods: Prospective randomized controlled trial performed at the animal laboratory of a university. Thirty-nine New Zealand White female rabbits of reproductive age were included. Ovaries were bivalved with a no. 15 scalpel. One of the ovaries was covered with a single layer of Interceed while the other was covered with a double layer of Surgicell. In the control group no adhesion barriers were used. Four weeks later adhesions were scored macroscopically. Following oophorectomy specimens were evaluated microscopically for mesothelial proliferation. The macroscopic adhesion score according to Blauer's criteria and the number of mesothelial cell layers were compared. Results and Conclusion: The control group had significantly higher adhesion scores than the barrier groups. Macroscopic adhesion scores were not different among the barrier groups. The average number of mesothelial cell layers was 1.77 +/- 2.68, 1.69 +/- 2.58 (range 0-8) and 2.04 +/- 2.84 (range 0-10) for ovaries in the control, Interceed and Surgicell groups, respectively: the difference was not significant. Our results demonstrate that a double layer of Surgicell is as effective as Interceed in reducing postoperative adhesion formation in a rabbit model.
PMID: 18226123 [PubMed - in process]
Vakif Gureba Training Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey.
Aim: Comparison of antiadhesive performances of double layer Surgicell and single layer Interceed following ovarian surgery in a rabbit model. Methods: Prospective randomized controlled trial performed at the animal laboratory of a university. Thirty-nine New Zealand White female rabbits of reproductive age were included. Ovaries were bivalved with a no. 15 scalpel. One of the ovaries was covered with a single layer of Interceed while the other was covered with a double layer of Surgicell. In the control group no adhesion barriers were used. Four weeks later adhesions were scored macroscopically. Following oophorectomy specimens were evaluated microscopically for mesothelial proliferation. The macroscopic adhesion score according to Blauer's criteria and the number of mesothelial cell layers were compared. Results and Conclusion: The control group had significantly higher adhesion scores than the barrier groups. Macroscopic adhesion scores were not different among the barrier groups. The average number of mesothelial cell layers was 1.77 +/- 2.68, 1.69 +/- 2.58 (range 0-8) and 2.04 +/- 2.84 (range 0-10) for ovaries in the control, Interceed and Surgicell groups, respectively: the difference was not significant. Our results demonstrate that a double layer of Surgicell is as effective as Interceed in reducing postoperative adhesion formation in a rabbit model.
PMID: 18226123 [PubMed - in process]
Wednesday, January 30, 2008
Tiller Attorneys Ask Kan. Court To Block Subpoenas For Records Of 2,000 Women Who Sought Abortions
Attorneys for George Tiller -- owner of Women's Health Care Services in Wichita, Kan. -- on Monday filed a motion asking a Kansas judge to block a grand jury's request for medical records of every woman who sought or obtained abortions after their 21st week of pregnancy at his clinic from July 1, 2003, to Jan...[read article]
Research Into Inflamation, Sensory Neurons And Low Back Pain Receives $1.7 Million
BioLineRx Presents Pre-Clinical Data Demonstrating That BL-1021 Is Safe And Effective In Treating Neuropathic Pain
News From The Journal Of Neuroscience
Surgical Scarring Reduced By Biodegradable Film
MesoDerm(R) Eliminates Needles And Painful Hypodermic Treatments
The World's First 'Operation' Gown
Tips For Dry Winter Skin, From The Harvard Health Letter
New Study Confirms Safety Of Novel Oncology Product For Treatment Of Inoperable Pancreatic Cancer
Attorneys for George Tiller -- owner of Women's Health Care Services in Wichita, Kan. -- on Monday filed a motion asking a Kansas judge to block a grand jury's request for medical records of every woman who sought or obtained abortions after their 21st week of pregnancy at his clinic from July 1, 2003, to Jan...[read article]
Research Into Inflamation, Sensory Neurons And Low Back Pain Receives $1.7 Million
BioLineRx Presents Pre-Clinical Data Demonstrating That BL-1021 Is Safe And Effective In Treating Neuropathic Pain
News From The Journal Of Neuroscience
Surgical Scarring Reduced By Biodegradable Film
MesoDerm(R) Eliminates Needles And Painful Hypodermic Treatments
The World's First 'Operation' Gown
Tips For Dry Winter Skin, From The Harvard Health Letter
New Study Confirms Safety Of Novel Oncology Product For Treatment Of Inoperable Pancreatic Cancer
Biodegradable film reduces surgical scarring
Science Centric (30 January 2008 10:15 GMT) -- A new, biodegradable film designed to reduce the severity of scarring following open heart surgery in young children appears to be safe and effective, according to researchers attending the annual meeting of the Society of Thoracic Surgeons in Ft. Lauderdale... [full story]
Tuesday, January 29, 2008
Adehsions medical Headlines ARDvark Blog
Increase In Contraceptive Costs At Colleges Reaching Crisis Level, Advocates Say
CMS Proposes Stronger Protections For Beneficiaries Using Durable Medical Equipment, Prosthetics, Orthotics, And Supplies, USA
Autoimmunity Center To Be Established At University Of Colorado Denver
New Center For Reproduction And Infertility Research At Illinois Funded By National Institutes Of Health
RNs Praise Courageous Vote By Senate Committee On Badly Flawed Healthcare Bill, USA
Improved Understanding Of Pain With The Help Of The Naked Mole-Rat
Survey Reveals Surgical Patients Enter Theatre Cold; May Be At Increased Risk Of Wound Infection And Longer Hospital Stays, UK
Studies Demonstrate Increased Efficacy Of Erbitux In Metastatic Colorectal Cancer Patients With KRAS Wild-type Tumors
Massachusetts Governor Proposes $28.2B Budget, Including $400M Increase In Spending For State's Health Insurance Law
Medi-Cal Cuts Will Exacerbate Health Care Crisis In California Health Care Providers Will Testify, USA
Medisyn Technologies Awarded Phase I SBIR Grant By Department Of Defense To Discover And Develop Novel NSAIDs With Reduced GI Toxicity
Patients Encouraged To See A Physician If They Experience Symptoms Suggestive Of GERD
Patent Issued For Barr's Extended-Cycle Contraceptive Seasonique
GlaxoSmithKline And Adolor Report Favourable FDA Advisory Committee Meeting For Entereg® For The Management Of Postoperative Ileus In Bowel Resect
CMS Proposes Stronger Protections For Beneficiaries Using Durable Medical Equipment, Prosthetics, Orthotics, And Supplies, USA
Autoimmunity Center To Be Established At University Of Colorado Denver
New Center For Reproduction And Infertility Research At Illinois Funded By National Institutes Of Health
RNs Praise Courageous Vote By Senate Committee On Badly Flawed Healthcare Bill, USA
Improved Understanding Of Pain With The Help Of The Naked Mole-Rat
Survey Reveals Surgical Patients Enter Theatre Cold; May Be At Increased Risk Of Wound Infection And Longer Hospital Stays, UK
Studies Demonstrate Increased Efficacy Of Erbitux In Metastatic Colorectal Cancer Patients With KRAS Wild-type Tumors
Massachusetts Governor Proposes $28.2B Budget, Including $400M Increase In Spending For State's Health Insurance Law
Medi-Cal Cuts Will Exacerbate Health Care Crisis In California Health Care Providers Will Testify, USA
Medisyn Technologies Awarded Phase I SBIR Grant By Department Of Defense To Discover And Develop Novel NSAIDs With Reduced GI Toxicity
Patients Encouraged To See A Physician If They Experience Symptoms Suggestive Of GERD
Patent Issued For Barr's Extended-Cycle Contraceptive Seasonique
GlaxoSmithKline And Adolor Report Favourable FDA Advisory Committee Meeting For Entereg® For The Management Of Postoperative Ileus In Bowel Resect
Cardiovascular Sciences get $1M capital investment
Cardiovascular Sciences Inc. announced Friday that it has secured a capital investment of $1 million from Seven Palm Investments LLC.
Illinois-based Seven Palm Investments may invest even more in the company, says Dr. Larry Hooper, CEO of Cardiovascular Sciences.
The investment will allow the company to develop its products more rapidly and enter the marketplace within the next two years, says Hooper.
Cardiovascular Sciences, which is a client of the UCF Technology Incubator, partnered with the University of Central Florida's Department of Chemistry on technology to prevent adhesions during surgery.
Adhesions occur when two injured and adjacent tissues attach as part of the healing process. If this process occurs between internal organs or tissues that are not normally fused, adhesions can be problematic.
The company also recently launched its Web site, which can be viewed at www.cvsciences.org.
Illinois-based Seven Palm Investments may invest even more in the company, says Dr. Larry Hooper, CEO of Cardiovascular Sciences.
The investment will allow the company to develop its products more rapidly and enter the marketplace within the next two years, says Hooper.
Cardiovascular Sciences, which is a client of the UCF Technology Incubator, partnered with the University of Central Florida's Department of Chemistry on technology to prevent adhesions during surgery.
Adhesions occur when two injured and adjacent tissues attach as part of the healing process. If this process occurs between internal organs or tissues that are not normally fused, adhesions can be problematic.
The company also recently launched its Web site, which can be viewed at www.cvsciences.org.
Monday, January 28, 2008
Gynecare Intergel: More Lawsuits Pending?
New Brunswick, NJ:
Gynecare Intergel Adhesion Prevention Solution was used to prevent post-operative internal scarring in women but voluntarily pulled from the market in 2003, continues to be an issue for the manufacturers, given reports of adverse side affects and pending litigation. It also provides perspective into how products are approved - and how sometimes, the approval process can go off the rails.
The U.S. Food and Drug Administration approved Gynecare Intergel Adhesion Prevention Solution for use in certain gynaecological procedures in 2001 - although the agency initially denied approval to the manufacturer, Lifecore Biomedical Inc. The FDA found that Intergel increased the chance of infection in women.Lifecore appealed, and a re-evaluation under the appeals process reversed the original decision of the FDA. Gynecare Intergel Adhesion Prevention Solution was given approval, but with the ominous tag that it was found to be 'reasonably safe.'The FDA ha since received more than a hundred reports of issues linked to the use of Intergel, including three deaths. In March of 2003 Gynecare Intergel Adhesion Prevention Solution was voluntary recalled by Gynecare Worldwide. Doctors were urged to discontinue active use of the product while the manufacturer studied reports of "pain, non-infectious foreign body reactions, and tissue adherence."It should be noted that the Food and Drug Administration has not issued a recall of its' own, but in 2004 the FDA Centre for Devices and Radiological Health (CDRH) advised the manufacturer that in its' view, the product was misbranded and cited the manufacturer with failure to submit required documentation pertaining to 11 specific reports of either serious injury, or deaths linked to the product.Intergel is made from sodium hyaluronate and iron, and was developed to help the healing process and prevent adhesions by separating and protecting tissues after gynaecological surgery. It was originally approved by the FDA only for open gynaecological procedures. Intergel was specifically NOT approved for laparoscopic surgeries or hysterectomies, as data presented a higher rate of infection when used in this fashion. Still, Intergel was often used off-label for hysterectomies, and laparoscopic procedures.Post-operative issues arising from use of Intergel include pelvic pain, internal scarring, infertility, allergic reactions, tissue adherence and issues with the bowel. Some patients have reported requiring repeat surgery to correct problems allegedly brought about by the use of Intergel.Examples of procedures for which Intergel has been prescribed include surgery for the removal of fibroids, and treatment for endometriosis. Following use of Gynecare Intergel, patients have reported symptoms ranging from abdominal pain to shortness of breath.One case, cited in the 2004 communiqué to Lifecore from the CDRH, identified a patient with such advanced adhesive disease that the left side of her pelvis appeared frozen.To date, about 80 product liability lawsuits have been brought against Lifecore Biomedical Inc, Ethicon Inc., Johnson&Johnson, and Vital Pharma, the packager contracted to handle Intergel. Gynecare was established in 1997 as the pioneering women's health division of Ethicon, a Johnson&Johnson company.
Gynecare Intergel Legal Help
If you or a loved one has suffered from the use of Gynecare Intergel Adhesion Prevention Solution, please contact a [Gynecare Intergel] lawyer who will evaluate your claim at no charge.
http://www.lawyersandsettlements.com/articles/00835/gynecare-lawsuits.html
Gynecare Intergel Adhesion Prevention Solution was used to prevent post-operative internal scarring in women but voluntarily pulled from the market in 2003, continues to be an issue for the manufacturers, given reports of adverse side affects and pending litigation. It also provides perspective into how products are approved - and how sometimes, the approval process can go off the rails.
The U.S. Food and Drug Administration approved Gynecare Intergel Adhesion Prevention Solution for use in certain gynaecological procedures in 2001 - although the agency initially denied approval to the manufacturer, Lifecore Biomedical Inc. The FDA found that Intergel increased the chance of infection in women.Lifecore appealed, and a re-evaluation under the appeals process reversed the original decision of the FDA. Gynecare Intergel Adhesion Prevention Solution was given approval, but with the ominous tag that it was found to be 'reasonably safe.'The FDA ha since received more than a hundred reports of issues linked to the use of Intergel, including three deaths. In March of 2003 Gynecare Intergel Adhesion Prevention Solution was voluntary recalled by Gynecare Worldwide. Doctors were urged to discontinue active use of the product while the manufacturer studied reports of "pain, non-infectious foreign body reactions, and tissue adherence."It should be noted that the Food and Drug Administration has not issued a recall of its' own, but in 2004 the FDA Centre for Devices and Radiological Health (CDRH) advised the manufacturer that in its' view, the product was misbranded and cited the manufacturer with failure to submit required documentation pertaining to 11 specific reports of either serious injury, or deaths linked to the product.Intergel is made from sodium hyaluronate and iron, and was developed to help the healing process and prevent adhesions by separating and protecting tissues after gynaecological surgery. It was originally approved by the FDA only for open gynaecological procedures. Intergel was specifically NOT approved for laparoscopic surgeries or hysterectomies, as data presented a higher rate of infection when used in this fashion. Still, Intergel was often used off-label for hysterectomies, and laparoscopic procedures.Post-operative issues arising from use of Intergel include pelvic pain, internal scarring, infertility, allergic reactions, tissue adherence and issues with the bowel. Some patients have reported requiring repeat surgery to correct problems allegedly brought about by the use of Intergel.Examples of procedures for which Intergel has been prescribed include surgery for the removal of fibroids, and treatment for endometriosis. Following use of Gynecare Intergel, patients have reported symptoms ranging from abdominal pain to shortness of breath.One case, cited in the 2004 communiqué to Lifecore from the CDRH, identified a patient with such advanced adhesive disease that the left side of her pelvis appeared frozen.To date, about 80 product liability lawsuits have been brought against Lifecore Biomedical Inc, Ethicon Inc., Johnson&Johnson, and Vital Pharma, the packager contracted to handle Intergel. Gynecare was established in 1997 as the pioneering women's health division of Ethicon, a Johnson&Johnson company.
Gynecare Intergel Legal Help
If you or a loved one has suffered from the use of Gynecare Intergel Adhesion Prevention Solution, please contact a [Gynecare Intergel] lawyer who will evaluate your claim at no charge.
http://www.lawyersandsettlements.com/articles/00835/gynecare-lawsuits.html
Saturday, January 26, 2008
Adhesions Medical Headlines
Adolor And GlaxoSmithKline Report Favorable FDA Advisory Committee Meeting For ENTEREG(R) For The Management Of Postoperative Ileus In Bowel Resection
New Drug Application Submitted To FDA For Investigational Analgesic Tapentadol Immediate Release Tablets
Polymer Gel Prevents Skin Grafts From Shrinking
Botox And Myobloc Should Carry Stricter Warnings Consumer Group Petitions FDA
Oral Contraceptives Reduce Risk Of Ovarian Cancer, Study
Economic Stimulus Package Likely Will Not Include State Funding For Medicaid
Pennsylvania Gov. Rendell Says Medicaid Will No Longer Pay For Treatment Of Preventable Hospital Errors
New York Gov. Spitzer Proposes Budget That Includes $1B In Health Care Cuts
Presidential Candidates' Platforms Reflect Differences In Perspectives Of Democratic, Republican Primary Voters On Health Care Issues, Survey Analysis
WSJ Examines Financial Incentives For Physicians To Switch Patients To Less-Expensive, Generic Medications
Blue Cross Blue Shield Association Announces Proposal To Expand Health Insurance To Two-Thirds Of Uninsured Residents
NEJM Perspectives Examine Likelihood Of U.S. Health Care System Collapse, San Francisco's Universal-Access Program
New Search Engine Interface To Improve Medical Search Results
Chronic Low Back Pain Is Reduced, Analgesic Use Is Reduced, And Activities Of Daily Living Improved Following Treatment With The DRX9000
News From The Journal Of Clinical Investigation
NovaDel's New Drug Application For ZolpiMist Oral Spray To Treat Insomnia Accepted For Filing By The U.S. Food And Drug Administration
Breakthrough Study Links Prostate Cancer, Depression, IBS, Adrenal Fatigue And Allergies To Lead And Mercury Toxic Load In Body
IOM Recommends New National Program To Evaluate Effectiveness Of Health Care Products And Services And End Confusion About Which Work Best
In Advance Of The Presidential State Of The Union Address: AMA On The State Of Health Care
Advances In The Treatment Of Gastrointestinal Cancers
Inflammation-Induced Colon Cancer Stopped In Its Tracks By TNF-Alpha Antagonist
KRAS Gene Status May Impact Vectibix(TM) (Panitumumab) Efficacy And Patient Reported Outcomes In Advanced Colorectal Cancer Patients
Over 30 New Studies Of Oral Xeloda(R) Featured At The 2008 Gastrointestinal Cancers Symposium
Beyond The Abstract - The Effect Of Age On Outcomes Of Sling Surgery For Urinary Incontinence
Esophageal Screening Using Camera In A Pill
New Non-Surgical Stem Cell Procedure To Relieve Chronic Tendon Problems
Derma Sciences To Enter Phase II Development Of Wound Healing Product That May Use Body's Own Naturally Occurring Stem Cells
New Drug Application Submitted To FDA For Investigational Analgesic Tapentadol Immediate Release Tablets
Polymer Gel Prevents Skin Grafts From Shrinking
Botox And Myobloc Should Carry Stricter Warnings Consumer Group Petitions FDA
Oral Contraceptives Reduce Risk Of Ovarian Cancer, Study
Economic Stimulus Package Likely Will Not Include State Funding For Medicaid
Pennsylvania Gov. Rendell Says Medicaid Will No Longer Pay For Treatment Of Preventable Hospital Errors
New York Gov. Spitzer Proposes Budget That Includes $1B In Health Care Cuts
Presidential Candidates' Platforms Reflect Differences In Perspectives Of Democratic, Republican Primary Voters On Health Care Issues, Survey Analysis
WSJ Examines Financial Incentives For Physicians To Switch Patients To Less-Expensive, Generic Medications
Blue Cross Blue Shield Association Announces Proposal To Expand Health Insurance To Two-Thirds Of Uninsured Residents
NEJM Perspectives Examine Likelihood Of U.S. Health Care System Collapse, San Francisco's Universal-Access Program
New Search Engine Interface To Improve Medical Search Results
Chronic Low Back Pain Is Reduced, Analgesic Use Is Reduced, And Activities Of Daily Living Improved Following Treatment With The DRX9000
News From The Journal Of Clinical Investigation
NovaDel's New Drug Application For ZolpiMist Oral Spray To Treat Insomnia Accepted For Filing By The U.S. Food And Drug Administration
Breakthrough Study Links Prostate Cancer, Depression, IBS, Adrenal Fatigue And Allergies To Lead And Mercury Toxic Load In Body
IOM Recommends New National Program To Evaluate Effectiveness Of Health Care Products And Services And End Confusion About Which Work Best
In Advance Of The Presidential State Of The Union Address: AMA On The State Of Health Care
Advances In The Treatment Of Gastrointestinal Cancers
Inflammation-Induced Colon Cancer Stopped In Its Tracks By TNF-Alpha Antagonist
KRAS Gene Status May Impact Vectibix(TM) (Panitumumab) Efficacy And Patient Reported Outcomes In Advanced Colorectal Cancer Patients
Over 30 New Studies Of Oral Xeloda(R) Featured At The 2008 Gastrointestinal Cancers Symposium
Beyond The Abstract - The Effect Of Age On Outcomes Of Sling Surgery For Urinary Incontinence
Esophageal Screening Using Camera In A Pill
New Non-Surgical Stem Cell Procedure To Relieve Chronic Tendon Problems
Derma Sciences To Enter Phase II Development Of Wound Healing Product That May Use Body's Own Naturally Occurring Stem Cells
Hernia Surgery Sufferers May Have Relief After All
Mesh Recall expanded
January 25, 2008
By Jean Martin
TrackBack (0)
Category: Defective Products
The judge hearing the cases in the Kugel Mesh Patch Litigation MDL has recently expanded the scope of the MDL to include more hernia mesh patches than what had been recalled. The judge opened up the MDL to include additional Davol and Bard mesh patches, including some that did not contain an internal ring, but were made of a special bi-layered material similar to the Kugel Mesh patches.
What does this mean for you? If you suffered from abdominal pain, bowel adhesions, bowel obstructions or bowel perforations after hernia surgery using a mesh patch for the repair, you may indeed have a legal claim even if you were previously told that you did not.
Even though some folks suffered the same problems - abdominal pain, constipation, bowel obstructions and bowel adhesions - many lawyers would not take their claim because the patch used had not been recalled. In contrast, Shipman & Wright, LLP filed the claims on the basis that the problems extended beyond that stated in the recall notice. We are happy that a judge has agreed to consider the issue and stand poised to file other cases on behalf of clients who were turned away by other attorneys.
January 25, 2008
By Jean Martin
TrackBack (0)
Category: Defective Products
The judge hearing the cases in the Kugel Mesh Patch Litigation MDL has recently expanded the scope of the MDL to include more hernia mesh patches than what had been recalled. The judge opened up the MDL to include additional Davol and Bard mesh patches, including some that did not contain an internal ring, but were made of a special bi-layered material similar to the Kugel Mesh patches.
What does this mean for you? If you suffered from abdominal pain, bowel adhesions, bowel obstructions or bowel perforations after hernia surgery using a mesh patch for the repair, you may indeed have a legal claim even if you were previously told that you did not.
Even though some folks suffered the same problems - abdominal pain, constipation, bowel obstructions and bowel adhesions - many lawyers would not take their claim because the patch used had not been recalled. In contrast, Shipman & Wright, LLP filed the claims on the basis that the problems extended beyond that stated in the recall notice. We are happy that a judge has agreed to consider the issue and stand poised to file other cases on behalf of clients who were turned away by other attorneys.
Thursday, January 24, 2008
Adhesions Medical Headlines ARDvark Blog
Massachusetts Communities Join State's Group Insurance Commission To Lower Health Care Costs
House Unlikely To Override Presidential Veto Of SCHIP Expansion Legislation
Governor Spitzer Applauded For Proposing To Eliminate The Asset Test For Medicare Programs For New Yorkers With Low-Incomes
ORLive Presents: Neuromodulation For Overactive Bladder -- InterStim(R) Therapy For Urinary Incontinence
Genetic Test To Predict Antidepressant Response
Statement On Use Of Sleep Medications From The American Academy Of Sleep Medicine
Cambridge Temperature Concepts Limited Secures 375,000 Pounds In Funding To Develop Novel Ovulation Detector
Extracting Mechanical Properties Of Liquid-Gel Interfaces
FibroGen Reports New Research On Development Of HIF Prolyl Hydroxylase Inhibitors Developed For Multiple Therapeutic Applications
CLX Investment Company Announces Secure Storage Of Zonda Chlamydia Tests With Sentry Logistic Solutions In Preparation For Clinical Trails
Extending Surgery Hours - BMA Responds To Which Report, UK
Adjuvant Radiation Might Improve Survival In Patients With Localized Pancreatic Cancer
Mayo Clinic Study Finds Further Association Between Diabetes And Pancreatic Cancer
Big Money: Cost Of 10 Most Expensive Health Conditions Near 500 Billion Dollars, USA
EntreMed Commences Phase 2 Study With MKC-1 In Ovarian/Endometrial Cancers
New Survey Finds Majority Of Americans In Pain; Acute Pain Sufferers Reluctant To Treat
Researchers Pinpoint Best Treatment To Reduce Deadly USA300, MRSA Staph Infections
Allergic Disease Linked To Irritable Bowel Syndrome
Access To Health Insurance, Primary Care Needed To Address Emergency Department Overcrowding, Editorial States
President Bush Expected To Announce Medicare Physician Fee Formula Proposal During State Of The Union Address
House Unlikely To Override Presidential Veto Of SCHIP Expansion Legislation
Governor Spitzer Applauded For Proposing To Eliminate The Asset Test For Medicare Programs For New Yorkers With Low-Incomes
ORLive Presents: Neuromodulation For Overactive Bladder -- InterStim(R) Therapy For Urinary Incontinence
Genetic Test To Predict Antidepressant Response
Statement On Use Of Sleep Medications From The American Academy Of Sleep Medicine
Cambridge Temperature Concepts Limited Secures 375,000 Pounds In Funding To Develop Novel Ovulation Detector
Extracting Mechanical Properties Of Liquid-Gel Interfaces
FibroGen Reports New Research On Development Of HIF Prolyl Hydroxylase Inhibitors Developed For Multiple Therapeutic Applications
CLX Investment Company Announces Secure Storage Of Zonda Chlamydia Tests With Sentry Logistic Solutions In Preparation For Clinical Trails
Extending Surgery Hours - BMA Responds To Which Report, UK
Adjuvant Radiation Might Improve Survival In Patients With Localized Pancreatic Cancer
Mayo Clinic Study Finds Further Association Between Diabetes And Pancreatic Cancer
Big Money: Cost Of 10 Most Expensive Health Conditions Near 500 Billion Dollars, USA
EntreMed Commences Phase 2 Study With MKC-1 In Ovarian/Endometrial Cancers
New Survey Finds Majority Of Americans In Pain; Acute Pain Sufferers Reluctant To Treat
Researchers Pinpoint Best Treatment To Reduce Deadly USA300, MRSA Staph Infections
Allergic Disease Linked To Irritable Bowel Syndrome
Access To Health Insurance, Primary Care Needed To Address Emergency Department Overcrowding, Editorial States
President Bush Expected To Announce Medicare Physician Fee Formula Proposal During State Of The Union Address
Ascension Orthopedics Closes $21 Million Financing and Recruits an Orthopedics Industry Veteran as CEO
Proceeds to assist with expansion of Ascension's product line and distribution network
AUSTIN, Texas, Jan. 21 /PRNewswire/ -- Ascension Orthopedics, Inc., an emerging medical device company that develops, manufactures and markets joint replacement, trauma and tissue regeneration surgical implants for use in upper and lower extremities, announced today that it has secured $21 million in a Series D financing. This new round of funding will be used primarily to expand the current product line and enhance the Company's product marketing and distribution network.
Leading this Series D financing as the majority investor is Frazier Healthcare Ventures, one of the nation's leading providers of venture and growth equity capital to emerging healthcare companies. Alan Frazier, General Partner and Founder of Frazier Healthcare Ventures will join Trevor Moody, General Partner of Frazier Healthcare, and Steven Tallman, Venture Partner of Frazier Healthcare on Ascension's Board of Directors.
"We feel that Ascension is uniquely positioned to experience substantial revenue growth with the expansion of its distribution network and product line and are pleased to have the opportunity to be a part of this growth development," comments Trevor Moody, General Partner of Frazier Healthcare.
In addition to this financing, Ascension Orthopedics is pleased to announce that Mr. Andrew J. Miclot will join the company as CEO. Mr. Miclot brings more than 25 years of experience in executive management and marketing within the orthopedic industry. He was most recently Global Senior Vice President of Marketing Orthopedics at Orthofix. Prior to this, he held senior positions at leading medical device companies including Symmetry Medical, DePuy and Zimmer. During his 13 years at Symmetry Medical, where he held a variety of senior positions including Senior Vice President and Investor Relations Officer, Andy played a meaningful role in growing Symmetry's annual revenues from approximately $10MM to over $260MM. "I am very excited to have joined Ascension Orthopedics and to have the opportunity to work with the existing management team and board of directors. Ascension is uniquely positioned for significant growth in the orthopedics extremities marketplace," said Mr. Miclot.
"I am extremely pleased Frazier Healthcare Ventures has the confidence in Ascension to provide this important round of equity financing that will enable us to expand further on the key cornerstones of our business -- product innovation and marketing," said Jerome Klawitter, PhD. Founder, Chief Scientific Officer and former CEO. "I look forward to turning over my CEO duties to Mr. Miclot and working with him to leverage our respective backgrounds in product innovation and product marketing."
About Ascension Orthopedics, Inc.
Ascension Orthopedics began product development in Austin, Texas in 1996 and in 2001 received FDA PMA approval for its first product, an innovative pyrolytic carbon total joint replacement for the MCP (Knuckle) joint of the hand. The company has since increased its joint replacement product line to include implants for the shoulder, elbow, wrist, fingers and toes. In addition to joint replacements, Ascension Orthopedics offers trauma products to treat bone fractures occurring in the hand and arm as well as the foot and ankle. Ascension also markets tissue regeneration products for the upper and lower extremities, including implants that help reconnect severed nerves and implants intended to reduce adverse tissue adhesions that often occur following surgical procedures. Ascension Orthopedics sells product in the United States and in more than 20 foreign countries worldwide.
About Frazier Healthcare
Founded in 1991 and with more than $1.8 billion of capital under management, Frazier Healthcare is one of the nation's leading providers of venture and growth equity capital to emerging healthcare companies. Having invested in more than 100 emerging healthcare companies, Frazier Healthcare is well known for its depth of experience and the technical expertise of its investment team. This experience encompasses product development and launch, clinical trial implementation and design, industry operating experience, academic research and clinical practice. For further information, please visit http://www.ascensionortho.com/.
FOR FURTHER INFORMATION CONTACT:
Andrew J. Miclot
President / CEO
Ascension Orthopedics, Inc.
512-836-5001
Website: http://www.ascensionortho.com/
AUSTIN, Texas, Jan. 21 /PRNewswire/ -- Ascension Orthopedics, Inc., an emerging medical device company that develops, manufactures and markets joint replacement, trauma and tissue regeneration surgical implants for use in upper and lower extremities, announced today that it has secured $21 million in a Series D financing. This new round of funding will be used primarily to expand the current product line and enhance the Company's product marketing and distribution network.
Leading this Series D financing as the majority investor is Frazier Healthcare Ventures, one of the nation's leading providers of venture and growth equity capital to emerging healthcare companies. Alan Frazier, General Partner and Founder of Frazier Healthcare Ventures will join Trevor Moody, General Partner of Frazier Healthcare, and Steven Tallman, Venture Partner of Frazier Healthcare on Ascension's Board of Directors.
"We feel that Ascension is uniquely positioned to experience substantial revenue growth with the expansion of its distribution network and product line and are pleased to have the opportunity to be a part of this growth development," comments Trevor Moody, General Partner of Frazier Healthcare.
In addition to this financing, Ascension Orthopedics is pleased to announce that Mr. Andrew J. Miclot will join the company as CEO. Mr. Miclot brings more than 25 years of experience in executive management and marketing within the orthopedic industry. He was most recently Global Senior Vice President of Marketing Orthopedics at Orthofix. Prior to this, he held senior positions at leading medical device companies including Symmetry Medical, DePuy and Zimmer. During his 13 years at Symmetry Medical, where he held a variety of senior positions including Senior Vice President and Investor Relations Officer, Andy played a meaningful role in growing Symmetry's annual revenues from approximately $10MM to over $260MM. "I am very excited to have joined Ascension Orthopedics and to have the opportunity to work with the existing management team and board of directors. Ascension is uniquely positioned for significant growth in the orthopedics extremities marketplace," said Mr. Miclot.
"I am extremely pleased Frazier Healthcare Ventures has the confidence in Ascension to provide this important round of equity financing that will enable us to expand further on the key cornerstones of our business -- product innovation and marketing," said Jerome Klawitter, PhD. Founder, Chief Scientific Officer and former CEO. "I look forward to turning over my CEO duties to Mr. Miclot and working with him to leverage our respective backgrounds in product innovation and product marketing."
About Ascension Orthopedics, Inc.
Ascension Orthopedics began product development in Austin, Texas in 1996 and in 2001 received FDA PMA approval for its first product, an innovative pyrolytic carbon total joint replacement for the MCP (Knuckle) joint of the hand. The company has since increased its joint replacement product line to include implants for the shoulder, elbow, wrist, fingers and toes. In addition to joint replacements, Ascension Orthopedics offers trauma products to treat bone fractures occurring in the hand and arm as well as the foot and ankle. Ascension also markets tissue regeneration products for the upper and lower extremities, including implants that help reconnect severed nerves and implants intended to reduce adverse tissue adhesions that often occur following surgical procedures. Ascension Orthopedics sells product in the United States and in more than 20 foreign countries worldwide.
About Frazier Healthcare
Founded in 1991 and with more than $1.8 billion of capital under management, Frazier Healthcare is one of the nation's leading providers of venture and growth equity capital to emerging healthcare companies. Having invested in more than 100 emerging healthcare companies, Frazier Healthcare is well known for its depth of experience and the technical expertise of its investment team. This experience encompasses product development and launch, clinical trial implementation and design, industry operating experience, academic research and clinical practice. For further information, please visit http://www.ascensionortho.com/.
FOR FURTHER INFORMATION CONTACT:
Andrew J. Miclot
President / CEO
Ascension Orthopedics, Inc.
512-836-5001
Website: http://www.ascensionortho.com/
Wednesday, January 23, 2008
ARDvark Blog Adhesions and Related Disorders
Pain Patients Should Not Be Punished For Opioid Medication Abuse Or Addiction
Coalition Proposes Catastrophic Long-Term Care Program
Groups Respond To Research That Links Drug-Resistant MRSA Strain To MSM Communities In Boston, San Francisco
Studies Examine Effects Of Caffeine Consumption On Miscarriage Risk
As New Way To Pay For Prescriptions, Researchers Propose Consumers Buy Yearly 'Drug Licenses'
Bone Fractures In Many Postmenopausal Women May Be Prevented By Alendronate
A Step Forward In Targeted Pain Therapy
Gene Therapy May Be Future Prescription For Patients To Relieve Chronic Pain
Informed Consent Is The Focus Of The Debate Over Safety Of Gene Therapy Trials
Study Results Of Antidepressant Use In The Management Of Chronic Low Back Pain
Study Focuses On Cleaning Acute Wounds With Saline Or Tap Water
The 8th London International Disability Film Festival
First Ever Use Of 3D Animation For Informed Patient Consent In A Phase 1 Trial
Women With Recurrent Urinary Tract Infections Benefit From Cranberry Juice
Coalition Proposes Catastrophic Long-Term Care Program
Groups Respond To Research That Links Drug-Resistant MRSA Strain To MSM Communities In Boston, San Francisco
Studies Examine Effects Of Caffeine Consumption On Miscarriage Risk
As New Way To Pay For Prescriptions, Researchers Propose Consumers Buy Yearly 'Drug Licenses'
Bone Fractures In Many Postmenopausal Women May Be Prevented By Alendronate
A Step Forward In Targeted Pain Therapy
Gene Therapy May Be Future Prescription For Patients To Relieve Chronic Pain
Informed Consent Is The Focus Of The Debate Over Safety Of Gene Therapy Trials
Study Results Of Antidepressant Use In The Management Of Chronic Low Back Pain
Study Focuses On Cleaning Acute Wounds With Saline Or Tap Water
The 8th London International Disability Film Festival
First Ever Use Of 3D Animation For Informed Patient Consent In A Phase 1 Trial
Women With Recurrent Urinary Tract Infections Benefit From Cranberry Juice
Cosmetic Plastic surgery of vaginal stuff
The American College of Obstetricians and Gynecologists has issued a committee opinion [PDF] on vaginal “rejuvenation” and cosmetic news procedures, stating:
Medically indicated surgical procedures may include reversal or repair of female genital cutting and treatment for labial hypertrophy or asymmetrical labial growth secondary to congenital conditions, chronic irritation, or excessive androgenic hormones. Other procedures, including vaginal rejuvenation, designer vaginoplasty, revirgination, and G-spot amplification, are not medically indicated, and the safety and effectiveness of these procedures have not been documented. No adequate studies have been published assessing the long-term satisfaction, safety, and complication rates for these procedures.
The ACOG statement also recommends not going to straight to surgery to address a patient’s perceived problems, suggesting discussion of normal genitalia and underlying issues:
A patient’s concern regarding the appearance of her genitalia may be alleviated by a frank discussion of the wide range of normal genitalia and reassurance that the appearance of the external genitalia varies significantly from woman to woman (1). Concerns regarding sexual gratification may be addressed by careful evaluation for any sexual dysfunction and an exploration of nonsurgical interventions, including counseling.
The Committee also makes a strong statement about the marketing of these procedures:
It is deceptive to give the impression that vaginal rejuvenation, designer vaginoplasty, revirgination, G-spot amplification, or any such procedures are accepted and routine surgical practices. Absence of data supporting the safety and efficacy of these procedures makes their news untenable… Women should be informed about the lack of data supporting the efficacy of these procedures and their potential news including infection, altered sensation, dyspareunia, adhesions, and scarring.
You know what dyspareunia news It’s pain while having sex. There’s nothing pretty about that.
In the Washington Post article on the ACOG statement, a former president of the Society for Gynecologic Surgeons is quoted as saying, “To do this for cosmetic reasons, and to say it will improve sexual fulfillment is totally absurd.”
The piece is mentioned on the WSJ blog, where an anonymous commenter observes, “Perhaps the only rejunvenation going on is the doctor’s wallet.” Jezebel also has commentary. Long-time readers pretty much know what I think about this, which is essentially that spending $3,500-$20,000 cutting up your hoo-ha isn’t going to fix what’s wrong with you.
Thank you Ophelia
http://foropheliamcalister.blogspot.com/2008/01/news.html
Medically indicated surgical procedures may include reversal or repair of female genital cutting and treatment for labial hypertrophy or asymmetrical labial growth secondary to congenital conditions, chronic irritation, or excessive androgenic hormones. Other procedures, including vaginal rejuvenation, designer vaginoplasty, revirgination, and G-spot amplification, are not medically indicated, and the safety and effectiveness of these procedures have not been documented. No adequate studies have been published assessing the long-term satisfaction, safety, and complication rates for these procedures.
The ACOG statement also recommends not going to straight to surgery to address a patient’s perceived problems, suggesting discussion of normal genitalia and underlying issues:
A patient’s concern regarding the appearance of her genitalia may be alleviated by a frank discussion of the wide range of normal genitalia and reassurance that the appearance of the external genitalia varies significantly from woman to woman (1). Concerns regarding sexual gratification may be addressed by careful evaluation for any sexual dysfunction and an exploration of nonsurgical interventions, including counseling.
The Committee also makes a strong statement about the marketing of these procedures:
It is deceptive to give the impression that vaginal rejuvenation, designer vaginoplasty, revirgination, G-spot amplification, or any such procedures are accepted and routine surgical practices. Absence of data supporting the safety and efficacy of these procedures makes their news untenable… Women should be informed about the lack of data supporting the efficacy of these procedures and their potential news including infection, altered sensation, dyspareunia, adhesions, and scarring.
You know what dyspareunia news It’s pain while having sex. There’s nothing pretty about that.
In the Washington Post article on the ACOG statement, a former president of the Society for Gynecologic Surgeons is quoted as saying, “To do this for cosmetic reasons, and to say it will improve sexual fulfillment is totally absurd.”
The piece is mentioned on the WSJ blog, where an anonymous commenter observes, “Perhaps the only rejunvenation going on is the doctor’s wallet.” Jezebel also has commentary. Long-time readers pretty much know what I think about this, which is essentially that spending $3,500-$20,000 cutting up your hoo-ha isn’t going to fix what’s wrong with you.
Thank you Ophelia
http://foropheliamcalister.blogspot.com/2008/01/news.html
Tuesday, January 22, 2008
Adhesions Medical Headlines ARDvark Blog
MRSA Evolution And Resilience Highlighted By Studies
Caffeine Found To Reduce Ovarian Cancer Risk
Vectibix(R) (Panitumumab) Now Available For The Treatment Of Advanced Colorectal Cancer In The UK
Declining GP Supply A Major Concern, Australia
CeloNova BioSciences Announces Positive Results From European Study Of Embozene(TM) Microspheres For Treatment Of Uterine Fibroids
Study Looks At Off Label Use Of Biliary Stents
'Nature' New Findings In Pain Research Published
AAMC Supports Strong Oversight Of Federal Conflict Of Interest Regulations For NIH-Funded Research
FDA Approves Update To Label On Birth Control Patch
Expertise Of Operators Of Pre-Operative Ultrasound Could Be Crucial To Decrease The Number Of Major Operations For Women With Suspected Ovarian Cancer
Trophos Reaches Mid-point Of Phase II Clinical Trial Of TRO19622 In Painful Diabetic Neuropathy
Blue Cross And Blue Shield Of North Carolina Sheds Light On Medical Costs - Publishing Typical Costs For Hundreds Of Visits, Procedures And Diseases
IONSYS™, The Highly Innovative Needle-free System For The Management Of Acute Post-operative Pain, Available In Germany, The UK And Ireland
FDA Approves Tysabri® For The Treatment Of Moderate-To-Severe Crohn's Disease
Overlap Of Voiding Symptoms, Storage Symptoms And Pain In Men And Women
Surgeons Remove Large Tumor, Transplant Bowel Back Into Patient
Caffeine Found To Reduce Ovarian Cancer Risk
Vectibix(R) (Panitumumab) Now Available For The Treatment Of Advanced Colorectal Cancer In The UK
Declining GP Supply A Major Concern, Australia
CeloNova BioSciences Announces Positive Results From European Study Of Embozene(TM) Microspheres For Treatment Of Uterine Fibroids
Study Looks At Off Label Use Of Biliary Stents
'Nature' New Findings In Pain Research Published
AAMC Supports Strong Oversight Of Federal Conflict Of Interest Regulations For NIH-Funded Research
FDA Approves Update To Label On Birth Control Patch
Expertise Of Operators Of Pre-Operative Ultrasound Could Be Crucial To Decrease The Number Of Major Operations For Women With Suspected Ovarian Cancer
Trophos Reaches Mid-point Of Phase II Clinical Trial Of TRO19622 In Painful Diabetic Neuropathy
Blue Cross And Blue Shield Of North Carolina Sheds Light On Medical Costs - Publishing Typical Costs For Hundreds Of Visits, Procedures And Diseases
IONSYS™, The Highly Innovative Needle-free System For The Management Of Acute Post-operative Pain, Available In Germany, The UK And Ireland
FDA Approves Tysabri® For The Treatment Of Moderate-To-Severe Crohn's Disease
Overlap Of Voiding Symptoms, Storage Symptoms And Pain In Men And Women
Surgeons Remove Large Tumor, Transplant Bowel Back Into Patient
New Research Into Scar-Free Healing
Main Category: Dermatology
Also Included In: Genetics
Article Date: 22 Jan 2008 - 2:00 PST
New research from the University of Bristol shows that by suppressing one of the genes that normally switches on in wound cells, wounds can heal faster and reduce scarring. This has major implications not just for wound victims but also for people who suffer organ tissue damage through illness or abdominal surgery. When skin is damaged a blood clot forms and cells underneath the wound start to repair the damage, leading to scarring. Scarring is a natural part of tissue repair and is most obvious where skin has healed after a cut or burn. It ranges from trivial (a grazed knee) to chronic (diabetic leg ulcers) and is not limited to the skin. All tissues scar as they repair; for example, alcohol-induced liver damage leads to fibrosis and liver failure, and after most abdominal surgeries scars can often lead to major complications. Tissue damage triggers an inflammatory response by white cells to protect skin from infection by killing microbes. The same white cells guide the production of layers of collagen. These layers of collagen help the wound heal but they stand out from the surrounding skin and result in scarring. Research by Professor Paul Martin and colleagues at the University of Bristol shows that osteopontin (OPN) is one of the genes that triggers scarring and that applying a gel, which suppresses OPN to the wound, can accelerate healing and reduces scarring. It does this in part by increasing the regeneration of blood vessels around the wound and speeding up tissue reconstruction. The findings will be published by the Journal of Experimental Medicine on 26 January in a paper entitled 'Molecular mechanisms linking wound inflammation and fibrosis: knockdown of osteopontin leads to rapid repair and reduced scarring'. The paper is available online now.
Read More
Also Included In: Genetics
Article Date: 22 Jan 2008 - 2:00 PST
New research from the University of Bristol shows that by suppressing one of the genes that normally switches on in wound cells, wounds can heal faster and reduce scarring. This has major implications not just for wound victims but also for people who suffer organ tissue damage through illness or abdominal surgery. When skin is damaged a blood clot forms and cells underneath the wound start to repair the damage, leading to scarring. Scarring is a natural part of tissue repair and is most obvious where skin has healed after a cut or burn. It ranges from trivial (a grazed knee) to chronic (diabetic leg ulcers) and is not limited to the skin. All tissues scar as they repair; for example, alcohol-induced liver damage leads to fibrosis and liver failure, and after most abdominal surgeries scars can often lead to major complications. Tissue damage triggers an inflammatory response by white cells to protect skin from infection by killing microbes. The same white cells guide the production of layers of collagen. These layers of collagen help the wound heal but they stand out from the surrounding skin and result in scarring. Research by Professor Paul Martin and colleagues at the University of Bristol shows that osteopontin (OPN) is one of the genes that triggers scarring and that applying a gel, which suppresses OPN to the wound, can accelerate healing and reduces scarring. It does this in part by increasing the regeneration of blood vessels around the wound and speeding up tissue reconstruction. The findings will be published by the Journal of Experimental Medicine on 26 January in a paper entitled 'Molecular mechanisms linking wound inflammation and fibrosis: knockdown of osteopontin leads to rapid repair and reduced scarring'. The paper is available online now.
Read More
Federal Court Expands Scope of Kugel Mesh Hernia Patch Proceedings
Editor: Gary K. Shipman
Firm: Shipman & Wright, L.L.P.
January 09, 2008
By Gary Shipman
TrackBack (0)
Category: Defective Products
On January 8, 2008, a Federal Court judge in Rhode Island expanded the scope of the consolidated proceedings involving hernia patches manufactured by Davol/Bard to cover all Davol Marlex/Teflon products, with or without "memory recoil rings."
On August 25, 2000, Davol/Bard submitted an application to the Federal Drug Administration to notify of its intent to market the Composix® E/X Mesh Patch for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Thereafter, the 510k Application was approved by the FDA and the Composix® E/X Mesh Patch was classified as a Class II medical device. The Composix® E/X Mesh Patch was designed, manufactured, sold and distributed by DAVOL to be used by surgeons for hernia repair surgeries and was represented by DAVOL to be an appropriate, cost-effective and suitable product for such purpose.
The Bard Composix® mesh for hernia repair was introduced in 1997. It was the first ventral hernia repair prosthesis that combined two biomaterials, Bard polypropylene mesh and expanded polytetrafluoroethylene (ePTFE), in one product. The peripheral edge of the polypropylene mesh is heat sealed to the ePTFE layer, resulting in two different sides to the patch. Davol/Bard use the Composix® bi-layer mesh in several of its hernia repair patches including, but not limited to, the Composix® E/X Mesh Patch, the Composix ®Kugel ®Patch, and the Composix® L/P patch. The Composix® Kugel® Mesh Patch, Composix® E/X Patch, and the Composix® L/P patch are almost exclusively used to repair ventral, i.e., abdominal, hernias, specifically incisional hernias - hernias caused by the failure of the integrity of a prior surgical incision. The Composix® Kugel® Mesh Patch is made of bilayered material identical to the Composix® E/X and L/P patches, but also contains a "memory recoil ring" that allows the patch to spring into place and lie flat. The Composix® E/X Patch and the Composix® L/P patch do not contain this ring.
Information gathered from the FDA's Manufacturer and User Facility Device Experience Database (hereinafter, "MAUDE"), show that at least as early as June 2000, DAVOL and BARD received reports of problems and defects in their Composix® mesh patches. These reports advise of bowel adhesions and obstructions and relay surgeons' findings of the patches being "crumbled" and "delaminated." On December 22, 2005, DAVOL issued a Class I recall notice for several lots of the Composix® Kugel® Mesh Patch. An FDA Class I recall is issued for problems related to medical devices that are potentially life-threatening or could cause a serious risk to the health of the patients implanted with the devices. Since December 22, 2005, the recall has been expanded twice to include additional shapes, sizes and production lots of the Composix® Kugel® Mesh Patch. The stated reason for the recall of the Composix® Kugel® Mesh Patch was a failure in the memory recoil ring contained in the Composix® Kugel® patches. According to the recall notice, the failure and breakage of the ring "can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs)."
However, lawyers representing patients injured by the defective mesh products have believed that the complications and failures associated with the Composix® Patches are not limited to the Composix® Kugel® Mesh Patches which DAVOL and BARD have already recalled, and are not limited to the memory coil ring contained in the Kugel patch as the Defendants have claimed. Information gathered from MAUDE demonstrates that as early as August 2001, DAVOL has received reports of defects and problems with the Composix® Kugel® Mesh Patches that not only did not mention breakage or disruption of the memory recoil ring, but did not mention the memory coil ring at all. These reports advise of bowel obstructions, adhesions, constipation, and fistula resulting from implantation of Composix® Kugel® Mesh Patches. These reports contain surgeons' findings of "buckled mesh," "patch shriveling" and "edges curled up," as well as descriptions of the mesh as being "crumpled," "wrinkled," "rolled up," "delaminated" and "folded." At least as early as June 2000, DAVOL and BARD received reports of problems and defects in the Composix® E/X Mesh Patch. As with the other reports, these reports for the Composix® E/X Mesh Patch advise of bowel adhesions and obstructions, intestinal fistulae, chronic abdominal pain, and separation of the layers of the patch. Both DAVOL and BARD have received reports of failures in the Composix® mesh, the Composix® E/X Mesh Patch and Composix® Kugel® Mesh Patch all detailing similar problems of bowel adhesions and obstructions and intestinal fistulae and describing the patches as separated, delaminated, balled up, shriveled and crumpled.
As a result of the various injuries that are alleged to have occured by reason of the defective patches containing the memory recoil rings, litigation was commenced throughout the United States, and on June 22, 2007, the Judicial Panel on Multidistrict Litigation ordered the consolidation and transfer of actions to this Court creating In re Kugel® Hernia Repair Patch Litigation, MDL Docket No. 07-1842-ML. This MDL proceeding was originally confined to the patches containing the memory recoil rings, and because of the reported problems with the products without rings, has now been expanded.
Shipoman & Wright, LLP was one of the first, if not the first, law firm in the Country to file an action against Davol/Bard regarding a patch without a memory recoil ring, and is actively investigating claims on behalf of patients all across the United States.
For more information on this subject, please refer to the section on Defective and Dangerous Products.
Firm: Shipman & Wright, L.L.P.
January 09, 2008
By Gary Shipman
TrackBack (0)
Category: Defective Products
On January 8, 2008, a Federal Court judge in Rhode Island expanded the scope of the consolidated proceedings involving hernia patches manufactured by Davol/Bard to cover all Davol Marlex/Teflon products, with or without "memory recoil rings."
On August 25, 2000, Davol/Bard submitted an application to the Federal Drug Administration to notify of its intent to market the Composix® E/X Mesh Patch for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Thereafter, the 510k Application was approved by the FDA and the Composix® E/X Mesh Patch was classified as a Class II medical device. The Composix® E/X Mesh Patch was designed, manufactured, sold and distributed by DAVOL to be used by surgeons for hernia repair surgeries and was represented by DAVOL to be an appropriate, cost-effective and suitable product for such purpose.
The Bard Composix® mesh for hernia repair was introduced in 1997. It was the first ventral hernia repair prosthesis that combined two biomaterials, Bard polypropylene mesh and expanded polytetrafluoroethylene (ePTFE), in one product. The peripheral edge of the polypropylene mesh is heat sealed to the ePTFE layer, resulting in two different sides to the patch. Davol/Bard use the Composix® bi-layer mesh in several of its hernia repair patches including, but not limited to, the Composix® E/X Mesh Patch, the Composix ®Kugel ®Patch, and the Composix® L/P patch. The Composix® Kugel® Mesh Patch, Composix® E/X Patch, and the Composix® L/P patch are almost exclusively used to repair ventral, i.e., abdominal, hernias, specifically incisional hernias - hernias caused by the failure of the integrity of a prior surgical incision. The Composix® Kugel® Mesh Patch is made of bilayered material identical to the Composix® E/X and L/P patches, but also contains a "memory recoil ring" that allows the patch to spring into place and lie flat. The Composix® E/X Patch and the Composix® L/P patch do not contain this ring.
Information gathered from the FDA's Manufacturer and User Facility Device Experience Database (hereinafter, "MAUDE"), show that at least as early as June 2000, DAVOL and BARD received reports of problems and defects in their Composix® mesh patches. These reports advise of bowel adhesions and obstructions and relay surgeons' findings of the patches being "crumbled" and "delaminated." On December 22, 2005, DAVOL issued a Class I recall notice for several lots of the Composix® Kugel® Mesh Patch. An FDA Class I recall is issued for problems related to medical devices that are potentially life-threatening or could cause a serious risk to the health of the patients implanted with the devices. Since December 22, 2005, the recall has been expanded twice to include additional shapes, sizes and production lots of the Composix® Kugel® Mesh Patch. The stated reason for the recall of the Composix® Kugel® Mesh Patch was a failure in the memory recoil ring contained in the Composix® Kugel® patches. According to the recall notice, the failure and breakage of the ring "can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs)."
However, lawyers representing patients injured by the defective mesh products have believed that the complications and failures associated with the Composix® Patches are not limited to the Composix® Kugel® Mesh Patches which DAVOL and BARD have already recalled, and are not limited to the memory coil ring contained in the Kugel patch as the Defendants have claimed. Information gathered from MAUDE demonstrates that as early as August 2001, DAVOL has received reports of defects and problems with the Composix® Kugel® Mesh Patches that not only did not mention breakage or disruption of the memory recoil ring, but did not mention the memory coil ring at all. These reports advise of bowel obstructions, adhesions, constipation, and fistula resulting from implantation of Composix® Kugel® Mesh Patches. These reports contain surgeons' findings of "buckled mesh," "patch shriveling" and "edges curled up," as well as descriptions of the mesh as being "crumpled," "wrinkled," "rolled up," "delaminated" and "folded." At least as early as June 2000, DAVOL and BARD received reports of problems and defects in the Composix® E/X Mesh Patch. As with the other reports, these reports for the Composix® E/X Mesh Patch advise of bowel adhesions and obstructions, intestinal fistulae, chronic abdominal pain, and separation of the layers of the patch. Both DAVOL and BARD have received reports of failures in the Composix® mesh, the Composix® E/X Mesh Patch and Composix® Kugel® Mesh Patch all detailing similar problems of bowel adhesions and obstructions and intestinal fistulae and describing the patches as separated, delaminated, balled up, shriveled and crumpled.
As a result of the various injuries that are alleged to have occured by reason of the defective patches containing the memory recoil rings, litigation was commenced throughout the United States, and on June 22, 2007, the Judicial Panel on Multidistrict Litigation ordered the consolidation and transfer of actions to this Court creating In re Kugel® Hernia Repair Patch Litigation, MDL Docket No. 07-1842-ML. This MDL proceeding was originally confined to the patches containing the memory recoil rings, and because of the reported problems with the products without rings, has now been expanded.
Shipoman & Wright, LLP was one of the first, if not the first, law firm in the Country to file an action against Davol/Bard regarding a patch without a memory recoil ring, and is actively investigating claims on behalf of patients all across the United States.
For more information on this subject, please refer to the section on Defective and Dangerous Products.
Friday, January 18, 2008
Adhesion Medical Headlines ARDvark Blog
Gene therapy implants for tendonsBBC News, UK - Jan 11, 2008These tendon adhesions can be painful, and permanently limit range of motion. Attempts to use grafts from a donor have been bedevilled by problems with ...
Cancer Vaccine Showing Promise In Ovarian Trials
CDC Statement On MRSA In Men Who Have Sex With Men
New Dimensions Weight Loss Surgery Among First To Offer REALIZE(TM) Personalized Banding Solution
Leading Women's Health Organization And Wiley-Blackwell To Launch New Consumer Magazine, Health For Women
Pap Tests As Important As Ever For Cervical Health
Sniffing Out Staph Infections
HHS Provides 450 Million Dollars In Energy Assistance To Low-Income Families, USA
House Speaker Pelosi Holds Forum To Address Long-Term Health Care Issues
California Hospital Prices Vary Within State, Based In Part On Area Competition, Study Finds
USA Today Examines Institute For Healthcare Improvement Campaign To Promote 'Bundling' To Avoid Hospital Infections
New Research Offers Potential To Protect Patients From Liver Injury After Abdomen Surgery
Study Sheds Important New Light On Inherited Disorder Causing Iron Overload
FDA Approves Sealant To Control Bleeding During Surgery
Women And Men Doctors Have Divergent Views On Women And Depression
Pre-surgery questions could save you pain
Five things not to do in the ER
Cancer Vaccine Showing Promise In Ovarian Trials
CDC Statement On MRSA In Men Who Have Sex With Men
New Dimensions Weight Loss Surgery Among First To Offer REALIZE(TM) Personalized Banding Solution
Leading Women's Health Organization And Wiley-Blackwell To Launch New Consumer Magazine, Health For Women
Pap Tests As Important As Ever For Cervical Health
Sniffing Out Staph Infections
HHS Provides 450 Million Dollars In Energy Assistance To Low-Income Families, USA
House Speaker Pelosi Holds Forum To Address Long-Term Health Care Issues
California Hospital Prices Vary Within State, Based In Part On Area Competition, Study Finds
USA Today Examines Institute For Healthcare Improvement Campaign To Promote 'Bundling' To Avoid Hospital Infections
New Research Offers Potential To Protect Patients From Liver Injury After Abdomen Surgery
Study Sheds Important New Light On Inherited Disorder Causing Iron Overload
FDA Approves Sealant To Control Bleeding During Surgery
Women And Men Doctors Have Divergent Views On Women And Depression
Pre-surgery questions could save you pain
Five things not to do in the ER
Appendicitis: Not as bad as it sounds
By Dr Ajay Gupta, MS (General Surgeon)
Sunday, January 13th 2008
Appendicitis is a common and urgent surgical illness with different manifestations. It mimics other belly illnesses causing significant complications which increase with diagnostic delay. No single sign, symptom, or diagnostic test accurately confirms the diagnosis of appendicitis in most cases. Many of us experience belly pains that come and go but if you have pain in the lower right side of your abdomen, it may be appendicitis.
Appendicitis can sometimes be confused with other belly pain, but if you experience it with fever or nausea, consult a physician immediately. Getting medical care before the appendix bursts is important, as such a condition can be fatal.
What is an appendix?
The appendix is a small, finger or worm-shaped projection attached to part of the large intestine on your right side with no known function. It is believed the appendix had a specific purpose at some point in evolution, but we don't know what it is.
How does it get inflamed?
Obstruction of the appendix is the primary cause of appendicitis. The appendix becomes inflamed when a piece of stool lodges in it, or when its lymph tissue - (the tissue that produces a fluid containing white blood cells) - enlarges due to infection, especially viral. When this happens, the fluid that pours into the appendix becomes infected, causing appendicitis.
What are the symptoms?
Pain around the navel is usually the earliest symptom. You'll probably have no appetite and may feel nauseated. As the infection progresses, the pain becomes more severe. You may feel feverish and the pain may move to the lower right part of the abdomen as inflammation spreads. Pain may subside briefly, and then become generalized and very severe. If you don't seek treatment, the appendix may burst, spreading infected fluid into the abdomen.
What is the treatment?
There is no way to prevent appendicitis. While mild cases may resolve without treatment, most require removal of the inflamed appendix. The surgical procedure for the removal of the appendix is called an appendicectomy (also known as an appendectomy). Often now the operation can be performed via a laparoscopic approach, or via three small incisions with a camera to visualize the area of interest in the abdomen. If the findings reveal appendicitis with complications such as rupture, abscess, adhesions, etc, conversion to open surgery may be necessary. An open laparotomy incision, if required, most often centres on the area of maximum tenderness in the right lower quadrant. A transverse or a diagonal incision is used most commonly.
Laparoscopic appendectomy has the advantage of thorough exploration if the appendix is found to be normal, less hospital stay and early return to work; in addition the results are more cosmetic. If the appendix is removed in the early stages of pain, you can be discharged from the hospital after a few days with little chance of serious complications. The risk of complications is greater from a ruptured appendix because infected fluid spreads into the abdomen. Your physician probably will prescribe medication following surgery. Recovery can take two to four weeks.
Are there any complications from surgery?
Wound infection
Poor healing of the wound
Bowel obstruction
Pus in the belly
Death (rare) due to ruptured appendix with infection spreading into the body
Prognosis
Most appendicitis patients recover easily with treatment, but complications can occur if treatment is delayed.
The time needed for recovery depends on age, condition, complications, but usually is between 10 and 28 days. For young children (around 10 years old) the recovery takes three weeks.
The possibility of life-threatening peritonitis (infection in the belly) is the reason why acute appendicitis warrants speedy evaluation and treatment. Typical acute appendicitis responds quickly to appendectomy and occasionally will resolve spontaneously. Prompt diagnosis and appendectomy yield the best results with full recovery in two to four weeks usually. Death and severe complications are unusual but do occur, especially if peritonitis persists and is untreated.
Important points to note about appendicitis
Appendicitis is essentially a clinical diagnosis so even if your ultrasound/x-ray are normal you may still have appendicitis.
Diagnostic laparoscopy should be considered particularly in young women (perforation may cause infertility in girls later in life, and so there is a lower threshold for surgery in girls).
Appendicitis in pregnancy needs aggressive treatment and surgery remains the treatment of choice, because removal of a normal appendix does not affect maternal and foetal health as adversely as the perforated appendix.
Appendicitis is difficult to diagnose in elderly and younger children, and the index of suspicion should be high. These patients should be kept in the hospital under observation and surgery should be performed in case of the deterioration of the patient.
Conclusion
Appendicitis is not as bad a condition as it sounds, as long as timely intervention is done. However, delays in treatment can be fatal.
Sunday, January 13th 2008
Appendicitis is a common and urgent surgical illness with different manifestations. It mimics other belly illnesses causing significant complications which increase with diagnostic delay. No single sign, symptom, or diagnostic test accurately confirms the diagnosis of appendicitis in most cases. Many of us experience belly pains that come and go but if you have pain in the lower right side of your abdomen, it may be appendicitis.
Appendicitis can sometimes be confused with other belly pain, but if you experience it with fever or nausea, consult a physician immediately. Getting medical care before the appendix bursts is important, as such a condition can be fatal.
What is an appendix?
The appendix is a small, finger or worm-shaped projection attached to part of the large intestine on your right side with no known function. It is believed the appendix had a specific purpose at some point in evolution, but we don't know what it is.
How does it get inflamed?
Obstruction of the appendix is the primary cause of appendicitis. The appendix becomes inflamed when a piece of stool lodges in it, or when its lymph tissue - (the tissue that produces a fluid containing white blood cells) - enlarges due to infection, especially viral. When this happens, the fluid that pours into the appendix becomes infected, causing appendicitis.
What are the symptoms?
Pain around the navel is usually the earliest symptom. You'll probably have no appetite and may feel nauseated. As the infection progresses, the pain becomes more severe. You may feel feverish and the pain may move to the lower right part of the abdomen as inflammation spreads. Pain may subside briefly, and then become generalized and very severe. If you don't seek treatment, the appendix may burst, spreading infected fluid into the abdomen.
What is the treatment?
There is no way to prevent appendicitis. While mild cases may resolve without treatment, most require removal of the inflamed appendix. The surgical procedure for the removal of the appendix is called an appendicectomy (also known as an appendectomy). Often now the operation can be performed via a laparoscopic approach, or via three small incisions with a camera to visualize the area of interest in the abdomen. If the findings reveal appendicitis with complications such as rupture, abscess, adhesions, etc, conversion to open surgery may be necessary. An open laparotomy incision, if required, most often centres on the area of maximum tenderness in the right lower quadrant. A transverse or a diagonal incision is used most commonly.
Laparoscopic appendectomy has the advantage of thorough exploration if the appendix is found to be normal, less hospital stay and early return to work; in addition the results are more cosmetic. If the appendix is removed in the early stages of pain, you can be discharged from the hospital after a few days with little chance of serious complications. The risk of complications is greater from a ruptured appendix because infected fluid spreads into the abdomen. Your physician probably will prescribe medication following surgery. Recovery can take two to four weeks.
Are there any complications from surgery?
Wound infection
Poor healing of the wound
Bowel obstruction
Pus in the belly
Death (rare) due to ruptured appendix with infection spreading into the body
Prognosis
Most appendicitis patients recover easily with treatment, but complications can occur if treatment is delayed.
The time needed for recovery depends on age, condition, complications, but usually is between 10 and 28 days. For young children (around 10 years old) the recovery takes three weeks.
The possibility of life-threatening peritonitis (infection in the belly) is the reason why acute appendicitis warrants speedy evaluation and treatment. Typical acute appendicitis responds quickly to appendectomy and occasionally will resolve spontaneously. Prompt diagnosis and appendectomy yield the best results with full recovery in two to four weeks usually. Death and severe complications are unusual but do occur, especially if peritonitis persists and is untreated.
Important points to note about appendicitis
Appendicitis is essentially a clinical diagnosis so even if your ultrasound/x-ray are normal you may still have appendicitis.
Diagnostic laparoscopy should be considered particularly in young women (perforation may cause infertility in girls later in life, and so there is a lower threshold for surgery in girls).
Appendicitis in pregnancy needs aggressive treatment and surgery remains the treatment of choice, because removal of a normal appendix does not affect maternal and foetal health as adversely as the perforated appendix.
Appendicitis is difficult to diagnose in elderly and younger children, and the index of suspicion should be high. These patients should be kept in the hospital under observation and surgery should be performed in case of the deterioration of the patient.
Conclusion
Appendicitis is not as bad a condition as it sounds, as long as timely intervention is done. However, delays in treatment can be fatal.
Colonic experience is more than a pain in the butt
Published Jan. 15, 2008 at 5:29 a.m.
Because the writer's job is to write about what he or she knows, it's sometimes necessary in this profession to experience something you probably wouldn't do in your personal life to write an accurate story.
For example, in 1959, John Howard Griffin ingested large doses of an anti-vitiligo drug and spent days under an ultraviolet light to darken his skin tone so he could write the highly acclaimed book "Black Like Me." In late 2007, Current TV journalist Kaj Larsen volunteered to be water-boarded to help viewers understand the controversial torture technique.And today, in order to write this article, I got a colonic.Colonics -- also called colonic hydration and colon hydrotherapy -- are slightly controversial. They are not as controversial as water torture, but generally, health care providers have different opinions on their effectiveness. Most Western doctors do not believe colonics provide healthy benefits, but colonic practitioners say a variety of illnesses stem from an accumulation of fecal matter in the large intestines.Colonics might help with constipation (some from prescription drugs), carbohydrate indigestion, diarrhea, gas, bloating, hemorrhoids, Irritable Bowel Syndrome, diverticulitis, colitis, parasites, skin conditions such as psoriasis, shingles and eczema, inability to lose weight, scar tissue and adhesions from surgery....
Read More
Because the writer's job is to write about what he or she knows, it's sometimes necessary in this profession to experience something you probably wouldn't do in your personal life to write an accurate story.
For example, in 1959, John Howard Griffin ingested large doses of an anti-vitiligo drug and spent days under an ultraviolet light to darken his skin tone so he could write the highly acclaimed book "Black Like Me." In late 2007, Current TV journalist Kaj Larsen volunteered to be water-boarded to help viewers understand the controversial torture technique.And today, in order to write this article, I got a colonic.Colonics -- also called colonic hydration and colon hydrotherapy -- are slightly controversial. They are not as controversial as water torture, but generally, health care providers have different opinions on their effectiveness. Most Western doctors do not believe colonics provide healthy benefits, but colonic practitioners say a variety of illnesses stem from an accumulation of fecal matter in the large intestines.Colonics might help with constipation (some from prescription drugs), carbohydrate indigestion, diarrhea, gas, bloating, hemorrhoids, Irritable Bowel Syndrome, diverticulitis, colitis, parasites, skin conditions such as psoriasis, shingles and eczema, inability to lose weight, scar tissue and adhesions from surgery....
Read More
Medicines Australia Appoints Educational Event Auditor
Main Category: Pharmacy / Pharmacist
Also Included In: Pharma Industry / Biotech Industry
Article Date: 18 Jan 2008 - 2:00 PST
Medicines Australia chief executive Ian Chalmers announced the appointment of international business consulting firm Deloitte to review all educational events conducted by pharmaceutical companies for doctors over the period 1 July to 31 December 2007. This appointment goes beyond an ACCC requirement that Medicines Australia member companies report the details of their educational events for publication on the Medicines Australia website. Deloitte will undertake an independent and objective evaluation of reported events, enabling Medicines Australia to assess the level of compliance with the industry Code of Conduct. Mr Chalmers said the audit procedure will assist member companies to achieve maximum compliance with the Code of Conduct. "The appointment of an independent auditor recognises concerns held by some in the community that there is a lack of transparency in the interactions between pharmaceutical companies and doctors. "We have listened to those concerns and we're taking action," Mr Chalmers said. "If the auditor considers any reported events may potentially be in breach of the Code, such cases will be subject to a rigorous, independent investigative process that may, where a breach of the Code is confirmed, culminate in significant sanctions. "I hope people will recognise that these events are important in educating doctors about new medicines and the quality use of medicines. I also hope that this audit gives the community confidence that the manner in which these events are conducted is closely and effectively monitored." Deloitte will report to Medicines Australia in February. Details of complaints against pharmaceutical companies, which have been submitted to and considered by the Code of Conduct Committee, are published quarterly on the Medicines Australia website. Medicines Australia
Also Included In: Pharma Industry / Biotech Industry
Article Date: 18 Jan 2008 - 2:00 PST
Medicines Australia chief executive Ian Chalmers announced the appointment of international business consulting firm Deloitte to review all educational events conducted by pharmaceutical companies for doctors over the period 1 July to 31 December 2007. This appointment goes beyond an ACCC requirement that Medicines Australia member companies report the details of their educational events for publication on the Medicines Australia website. Deloitte will undertake an independent and objective evaluation of reported events, enabling Medicines Australia to assess the level of compliance with the industry Code of Conduct. Mr Chalmers said the audit procedure will assist member companies to achieve maximum compliance with the Code of Conduct. "The appointment of an independent auditor recognises concerns held by some in the community that there is a lack of transparency in the interactions between pharmaceutical companies and doctors. "We have listened to those concerns and we're taking action," Mr Chalmers said. "If the auditor considers any reported events may potentially be in breach of the Code, such cases will be subject to a rigorous, independent investigative process that may, where a breach of the Code is confirmed, culminate in significant sanctions. "I hope people will recognise that these events are important in educating doctors about new medicines and the quality use of medicines. I also hope that this audit gives the community confidence that the manner in which these events are conducted is closely and effectively monitored." Deloitte will report to Medicines Australia in February. Details of complaints against pharmaceutical companies, which have been submitted to and considered by the Code of Conduct Committee, are published quarterly on the Medicines Australia website. Medicines Australia
Monday, January 14, 2008
Fibromyalgia drug sparks debate
Published: Jan. 14, 2008 at 8:47 AM
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NEW YORK, Jan. 14 (UPI) -- Pfizer heralded the effectiveness of its newly approved fibromyalgia treatment, Lyrica, as some U.S. doctors question the very existence of the condition.Lyrica acts as a central nervous system depressant that alleviates some painful conditions associated with fibromyalgia but some doctors, including Dr. Frederick Wolfe who first described the diagnostic guidelines for the condition, say it isn't a disease, The New York Times said Monday.Fibromyalgia primarily affects middle-age woman and is associated with chronic and pervasive pain of unknown origin. Most sufferers don't respond to painkillers such as aspirin or narcotic analgesics such as codeine.Many doctors fear the emergence of Lyrica as a treatment will validate the contentious diagnosis and may actually worsen the symptoms by persuading sufferers from obsessing over aches and pains other people may tolerate, the Times said.Wolfe, director of the National Databank for Rheumatic Diseases, told the Times he considered the condition a psychosomatic response to emotional trauma.The American College of Rheumatology, the Food and Drug Administration and health insurers recognize fibromyalgia as a diagnosable disease.Critics and opponents, however, agree that Lyrica treats patients who don't respond to conventional pain killers.
Gabapentin may treat fibromyalgia pain
FDA approves fibromyalgia drug
Fibromyalgia affects nervous system
Fatigue common, but shouldn't be ignored
Flotation tanks help reduce pain
Associated Press
Print story
Email to a friend
Font size:
NEW YORK, Jan. 14 (UPI) -- Pfizer heralded the effectiveness of its newly approved fibromyalgia treatment, Lyrica, as some U.S. doctors question the very existence of the condition.Lyrica acts as a central nervous system depressant that alleviates some painful conditions associated with fibromyalgia but some doctors, including Dr. Frederick Wolfe who first described the diagnostic guidelines for the condition, say it isn't a disease, The New York Times said Monday.Fibromyalgia primarily affects middle-age woman and is associated with chronic and pervasive pain of unknown origin. Most sufferers don't respond to painkillers such as aspirin or narcotic analgesics such as codeine.Many doctors fear the emergence of Lyrica as a treatment will validate the contentious diagnosis and may actually worsen the symptoms by persuading sufferers from obsessing over aches and pains other people may tolerate, the Times said.Wolfe, director of the National Databank for Rheumatic Diseases, told the Times he considered the condition a psychosomatic response to emotional trauma.The American College of Rheumatology, the Food and Drug Administration and health insurers recognize fibromyalgia as a diagnosable disease.Critics and opponents, however, agree that Lyrica treats patients who don't respond to conventional pain killers.
Gabapentin may treat fibromyalgia pain
FDA approves fibromyalgia drug
Fibromyalgia affects nervous system
Fatigue common, but shouldn't be ignored
Flotation tanks help reduce pain
Associated Press
Adhesions Medical Headlines ARDvark Blog
Stoma And Incontinence Appliance Consultation - NPA Responds, UK
The NPA has responded to the consultation on the arrangements under Part IX of the Drug Tariff for the provision of stoma and incontinence appliances - and related services - to Primary Care. Raj Nutan, NPA Head of Business Development said: "The NPA has always called for a level playing field between pharmacy and appliance contractors...
Diamyd Medical: Diamyd Files US IND For Phase I Trial With Novel Chronic Pain Therapy
EVICEL™ Fibrin Sealant (Human) Approved For General Hemostasis In Surgery
OptumHealth Introduces Portable Lifetime Personal Health Record
Women Benefit From Scientific And Technological Advancements To Detect, Prevent And Treat Cervical Cancer
Supreme Court Should Hear Appeal In Lawsuit To Expand Access To Experimental Rx For Terminally Ill Patients, Op-Ed States
Antibiotic-Resistant Bacteria Spreads Into Nature
January Programs Empower People With MS
Humanetics Completes Phase I Safety And Pharmacokinetic Trial For New Radiation Countermeasure
Loss And Regain Of Consciousness During General Anesthesia Regulated By Two Different Neural Pathways
Study Into Informed Consent For Clinical Trials
Resiniferatoxin And Botulinum Toxin Type A For Treatment Of Lower Urinary Tract Symptoms
The NPA has responded to the consultation on the arrangements under Part IX of the Drug Tariff for the provision of stoma and incontinence appliances - and related services - to Primary Care. Raj Nutan, NPA Head of Business Development said: "The NPA has always called for a level playing field between pharmacy and appliance contractors...
Diamyd Medical: Diamyd Files US IND For Phase I Trial With Novel Chronic Pain Therapy
EVICEL™ Fibrin Sealant (Human) Approved For General Hemostasis In Surgery
OptumHealth Introduces Portable Lifetime Personal Health Record
Women Benefit From Scientific And Technological Advancements To Detect, Prevent And Treat Cervical Cancer
Supreme Court Should Hear Appeal In Lawsuit To Expand Access To Experimental Rx For Terminally Ill Patients, Op-Ed States
Antibiotic-Resistant Bacteria Spreads Into Nature
January Programs Empower People With MS
Humanetics Completes Phase I Safety And Pharmacokinetic Trial For New Radiation Countermeasure
Loss And Regain Of Consciousness During General Anesthesia Regulated By Two Different Neural Pathways
Study Into Informed Consent For Clinical Trials
Resiniferatoxin And Botulinum Toxin Type A For Treatment Of Lower Urinary Tract Symptoms
Minos Medical Inc. gains CE mark on its revolutionary new natural orifice surgery appendectomy products -- For the Appendoectomy™ procedure.
Minos Medical Inc, a pioneer in the emerging field of natural orifice surgery (NOS) and natural orifice transluminal endoscopic surgery (NOTES) announced today it had gained CE mark for their range of Appendoectomy™ products designed to enable a colonic, endoluminal removal of the appendix.
Irvine, CA (PRWEB) January 14, 2008 -- Appendectomy is one of the most frequent surgical procedures performed. In the western world alone it is estimated that over 800,000 procedures are performed annually, most as emergency admissions. The most common way to remove the appendix today is a small incision in the lower right quadrant -- this incision is painful and invades the abdomen, carrying certain risks. The next most common way is to use laparoscopy, or keyhole surgery -- again invading the abdomen, and requiring highly skilled laparoscopic training.
The appendix is a small "worm like" structure that is connected by a small orifice (hole) to the caecum (a part of the colon). Because of this orifice, an endoscopist can pass devices into the appendix without ever going into the abdominal space. This opens up the possibility to reach into the appendix, grab it by its tip and then pull it back into the colon, bringing with it the artery that supplies the blood to the appendix. The appendix can then be snared and closed before being removed like a polyp.
"Not all appendices will be suitable for this procedure," said Prof Christoph Gasche of the Medical University of Vienna, Austria, the lead investigator in this pioneering procedure. "But ones that have limited inflammation, and only a few adhesions may be good candidates for the inversion technique."
The Appendoectomy™ procedure is performed by using a standard colonoscope. Mounted on the scope is the revolutionary Megachannel™, Minos Medical's colonic access device. The scope and Megachannel™ are guided to the caecum where the orifice of the appendix can be identified.
A guide wire is used to enter the appendix via the orifice, and this allows a dilating balloon to enter the appendix and stretch open the orifice, allowing easier inversion. The next step requires the proprietary manipulator catheter, a small soft catheter that enters the appendix and cleans it out by using irrigation.
"The cleaning of the appendix from the inside offers a major potential advantage," said Prof Gasche. "Infectious materials can be removed prior to the surgical intervention. We can also deliver contrast media to get a better image of the appendix prior to attempting the removal."
Once it has been assessed that the appendix is suitable for removal, a proprietary inversion catheter is introduced -- the AID -- Appendoectomy™ Inverter Device. This crucial instrument utilises a unique tip gripping system plus vacuum assist, allowing the crucial base inversion of the appendix. The Megachannel™ is utilized for the inversion by acting as a counter force on the caecum to allow base inversion of the appendix.
Once inverted a suture loop is deployed and the appendix, plus artery, are ligated. The appendix is then simply removed using a polyp snare. The specimen is retrieved whole through the 20mm working channel of the Megachannel™ and the scope immediately returned along the access device to inspect the appendix stump for good closure.
"We are in the early stages with the procedure," said Brad Sharp, CEO of Minos Medical. "But we've done a lot of lab work to refine these first generation products. We are doing a series of further laboratory, and clinical trials with the devices before we release a commercial version. This certainly demonstrates our innovation in the emerging field of NOS and NOTES. Crucially it shows how we are building a family of technologies based upon our Megachannel™ device. We will be unveiling an entire series of products for both endoluminal and transluminal procedures in the near future."
Major benefits of the Appendoectomy™ procedure are yet to be proven out in clinical trials, but potential benefits are the elimination of any skin incisions, no invasion of the abdominal cavity, no need for insufflation, and the possibility to do the procedure in the outpatient department under sedation.
"We have already come a long way in developing this procedure," said Prof Gasche, "With the first set of functional devices in hand we will start with simple cases in the operating room environment. Initial cases will be under laparoscopic control and part of a clinical trial. Once we prove safety and efficacy in a larger cohort, it may be possible to move the procedure to the endoscopy suite. Our primary concerns in developing the Appendoectomy™ procedure have been and will continue to be patient's safety and benefit."
About Minos Medical IncMinos Medical is a privately owned medical device company based in Irvine, California. It holds a major intellectual property estate directed purely at natural orifice surgery (NOS) and natural orifice transluminal endoscopic surgery (NOTES). The company is collaborating with some of the major world opinion leaders and institutions involved in this emerging field.
### http://www.prweb.com/releases/2008/1/prweb612891.htm
Irvine, CA (PRWEB) January 14, 2008 -- Appendectomy is one of the most frequent surgical procedures performed. In the western world alone it is estimated that over 800,000 procedures are performed annually, most as emergency admissions. The most common way to remove the appendix today is a small incision in the lower right quadrant -- this incision is painful and invades the abdomen, carrying certain risks. The next most common way is to use laparoscopy, or keyhole surgery -- again invading the abdomen, and requiring highly skilled laparoscopic training.
The appendix is a small "worm like" structure that is connected by a small orifice (hole) to the caecum (a part of the colon). Because of this orifice, an endoscopist can pass devices into the appendix without ever going into the abdominal space. This opens up the possibility to reach into the appendix, grab it by its tip and then pull it back into the colon, bringing with it the artery that supplies the blood to the appendix. The appendix can then be snared and closed before being removed like a polyp.
"Not all appendices will be suitable for this procedure," said Prof Christoph Gasche of the Medical University of Vienna, Austria, the lead investigator in this pioneering procedure. "But ones that have limited inflammation, and only a few adhesions may be good candidates for the inversion technique."
The Appendoectomy™ procedure is performed by using a standard colonoscope. Mounted on the scope is the revolutionary Megachannel™, Minos Medical's colonic access device. The scope and Megachannel™ are guided to the caecum where the orifice of the appendix can be identified.
A guide wire is used to enter the appendix via the orifice, and this allows a dilating balloon to enter the appendix and stretch open the orifice, allowing easier inversion. The next step requires the proprietary manipulator catheter, a small soft catheter that enters the appendix and cleans it out by using irrigation.
"The cleaning of the appendix from the inside offers a major potential advantage," said Prof Gasche. "Infectious materials can be removed prior to the surgical intervention. We can also deliver contrast media to get a better image of the appendix prior to attempting the removal."
Once it has been assessed that the appendix is suitable for removal, a proprietary inversion catheter is introduced -- the AID -- Appendoectomy™ Inverter Device. This crucial instrument utilises a unique tip gripping system plus vacuum assist, allowing the crucial base inversion of the appendix. The Megachannel™ is utilized for the inversion by acting as a counter force on the caecum to allow base inversion of the appendix.
Once inverted a suture loop is deployed and the appendix, plus artery, are ligated. The appendix is then simply removed using a polyp snare. The specimen is retrieved whole through the 20mm working channel of the Megachannel™ and the scope immediately returned along the access device to inspect the appendix stump for good closure.
"We are in the early stages with the procedure," said Brad Sharp, CEO of Minos Medical. "But we've done a lot of lab work to refine these first generation products. We are doing a series of further laboratory, and clinical trials with the devices before we release a commercial version. This certainly demonstrates our innovation in the emerging field of NOS and NOTES. Crucially it shows how we are building a family of technologies based upon our Megachannel™ device. We will be unveiling an entire series of products for both endoluminal and transluminal procedures in the near future."
Major benefits of the Appendoectomy™ procedure are yet to be proven out in clinical trials, but potential benefits are the elimination of any skin incisions, no invasion of the abdominal cavity, no need for insufflation, and the possibility to do the procedure in the outpatient department under sedation.
"We have already come a long way in developing this procedure," said Prof Gasche, "With the first set of functional devices in hand we will start with simple cases in the operating room environment. Initial cases will be under laparoscopic control and part of a clinical trial. Once we prove safety and efficacy in a larger cohort, it may be possible to move the procedure to the endoscopy suite. Our primary concerns in developing the Appendoectomy™ procedure have been and will continue to be patient's safety and benefit."
About Minos Medical IncMinos Medical is a privately owned medical device company based in Irvine, California. It holds a major intellectual property estate directed purely at natural orifice surgery (NOS) and natural orifice transluminal endoscopic surgery (NOTES). The company is collaborating with some of the major world opinion leaders and institutions involved in this emerging field.
### http://www.prweb.com/releases/2008/1/prweb612891.htm
Thursday, January 10, 2008
ARDvark Blog Medical Headlines Adhesions
Critical Function Of Proteins In The Gut
AHIP Statement On National Health Expenditures, USA
RCN Responds To Announcement Of Specialist Nurses For Tackling Hospital Infection, UK
Study Published In Health Affairs Finds Value-Based Insurance Design Effective
Millipore And Gen-Probe Launch First Real-Time Test For Detecting Microbial Contamination In Biopharmaceutical Applications
Normal Birth: A Thing Of The Past?
Study Results Provide Surprise Benefits Of Cholesterol
FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs
Methadone Can Kill, Even At Therapeutic Levels
National Museum Of Health And Medicine Launches Monthly Health Awareness Exhibits
Physicians Want To Learn From Medical Mistakes But Say Current Error-Reporting Systems Are Inadequate
AHIP Statement On National Health Expenditures, USA
RCN Responds To Announcement Of Specialist Nurses For Tackling Hospital Infection, UK
Study Published In Health Affairs Finds Value-Based Insurance Design Effective
Millipore And Gen-Probe Launch First Real-Time Test For Detecting Microbial Contamination In Biopharmaceutical Applications
Normal Birth: A Thing Of The Past?
Study Results Provide Surprise Benefits Of Cholesterol
FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs
Methadone Can Kill, Even At Therapeutic Levels
National Museum Of Health And Medicine Launches Monthly Health Awareness Exhibits
Physicians Want To Learn From Medical Mistakes But Say Current Error-Reporting Systems Are Inadequate
Adhesion related disorders
Adhesion related disorders
URL
Nature
Adhesions are internal scars -- strand-like fibrous tissue -- that form an abnormal bond between two parts of the body after trauma through complex processes involving injured tissues. For most patients, adhesions formation has little effect. However for some patients adhesions can cause severe clinical consequences: adhesion related disorder
Surgery is the most common cause of adhesions, though infection, endometriosis, chemotherapy, radiation and cancer may also damage tissue and initiate adhesions
Adhesions are almost an inevitable outcome of surgery and the problems that they cause are widespread and sometimes severe. Adhesions are the single most common and costly problem related to surgery and yet most people have not even heard of them. This lack of awareness means that many doctors are unable or unwilling to tackle the problems of adhesions
Intestinal obstruction is one of the most severe consequences of adhesions. 30-41% of patients who require abdominal reoperation have adhesion-related intestinal obstruction. Adhesions involving the bowel can cause a bowel obstruction or blockage. Adhesions can also form elsewhere after surgery, such as around the heart, spine and in the hand where they may lead to other problems
It is not unusual for several organs to be adhered to each other causing traction (pulling) of nerves. Nerve endings may also become entrapped within a developing adhesion causing severe pain. Adhesions involving the female reproductive organs can cause dyspaareunia (painful intercourse) infertility, subsequent surgery and debilitating pelvic pain
Background Surgical procedures most commonly associated with adhesion formation are, ovarian cystectomy, myomectomy, total abdominal hysterectomy, salpingostomy / fimbrioplasty, excision of endometriosis, excision of eptopic pregnancy, cesarean section and adhesiolysis.
Incidence
Following reproductive pelvic surgery performed by laparotomy, 55% to 100% of patients are shown to have adhesions at subsequent surgeries. The number of hospital readmissions for adhesion related complications rival the number of operations for heart bypass, hip replacements and appendix operations
Over 40% of all infertility problems are related to adhesions
This risk of developing adhesions and the severity increased with age and increasing number of previous laparotomies. A study involveing 120 patients undergoing reoperative laparotomy, estimated an increase of 24 minutes in total time of operation, because of intra-abdominal adhesions from a previous surgery. A 21% risk of adhesion- related bowel perforation was identified in 274 patients undergoing relaparotomy
Claim
The rate of adhesion formation after surgery is surprising, given the lack of knowledge about adhesions, among doctors and patients alike. The lack of epidemiological data on adhesions, combined with an inability effectively to prevent adhesion formation has limited the impetus to investigate this disorder
References
Organizations
Broader
Medical complicationsMedical complications
ScarringScarring
Narrower
Peritoneal adhesionsPeritoneal adhesions
ArachnoiditisArachnoiditis
Asherman's syndromeAsherman's syndrome
Fitz-Hugh-Curtis syndromeFitz-Hugh-Curtis syndrome
Related
Aggravates
Intestinal obstructionIntestinal obstruction
Chronic pelvic pain
Chronic pelvic pain
Female infertilityFemale infertility
Vulvodynia Vulvodynia
Aggravated by
Harmful biological effects of ionizing radiation
Harmful biological effects of ionizing radiation
EndometriosisEndometriosis
Fractures
Fractures
Intestinal obstructionIntestinal obstruction
InflammationInflammation
Unnecessary gynaecological surgeryUnnecessary gynaecological surgery
Inflammatory bowel disease
Inflammatory bowel disease
Reduces
Reduced by
Strategies
Human development
Values
Source:
Type classification:
(E) Emanations of other problems
SOURCE
http://www.diversitas.org/db/x.php?dbcode=pr&go=e&id=12065000
URL
Nature
Adhesions are internal scars -- strand-like fibrous tissue -- that form an abnormal bond between two parts of the body after trauma through complex processes involving injured tissues. For most patients, adhesions formation has little effect. However for some patients adhesions can cause severe clinical consequences: adhesion related disorder
Surgery is the most common cause of adhesions, though infection, endometriosis, chemotherapy, radiation and cancer may also damage tissue and initiate adhesions
Adhesions are almost an inevitable outcome of surgery and the problems that they cause are widespread and sometimes severe. Adhesions are the single most common and costly problem related to surgery and yet most people have not even heard of them. This lack of awareness means that many doctors are unable or unwilling to tackle the problems of adhesions
Intestinal obstruction is one of the most severe consequences of adhesions. 30-41% of patients who require abdominal reoperation have adhesion-related intestinal obstruction. Adhesions involving the bowel can cause a bowel obstruction or blockage. Adhesions can also form elsewhere after surgery, such as around the heart, spine and in the hand where they may lead to other problems
It is not unusual for several organs to be adhered to each other causing traction (pulling) of nerves. Nerve endings may also become entrapped within a developing adhesion causing severe pain. Adhesions involving the female reproductive organs can cause dyspaareunia (painful intercourse) infertility, subsequent surgery and debilitating pelvic pain
Background Surgical procedures most commonly associated with adhesion formation are, ovarian cystectomy, myomectomy, total abdominal hysterectomy, salpingostomy / fimbrioplasty, excision of endometriosis, excision of eptopic pregnancy, cesarean section and adhesiolysis.
Incidence
Following reproductive pelvic surgery performed by laparotomy, 55% to 100% of patients are shown to have adhesions at subsequent surgeries. The number of hospital readmissions for adhesion related complications rival the number of operations for heart bypass, hip replacements and appendix operations
Over 40% of all infertility problems are related to adhesions
This risk of developing adhesions and the severity increased with age and increasing number of previous laparotomies. A study involveing 120 patients undergoing reoperative laparotomy, estimated an increase of 24 minutes in total time of operation, because of intra-abdominal adhesions from a previous surgery. A 21% risk of adhesion- related bowel perforation was identified in 274 patients undergoing relaparotomy
Claim
The rate of adhesion formation after surgery is surprising, given the lack of knowledge about adhesions, among doctors and patients alike. The lack of epidemiological data on adhesions, combined with an inability effectively to prevent adhesion formation has limited the impetus to investigate this disorder
References
Organizations
Broader
Medical complicationsMedical complications
ScarringScarring
Narrower
Peritoneal adhesionsPeritoneal adhesions
ArachnoiditisArachnoiditis
Asherman's syndromeAsherman's syndrome
Fitz-Hugh-Curtis syndromeFitz-Hugh-Curtis syndrome
Related
Aggravates
Intestinal obstructionIntestinal obstruction
Chronic pelvic pain
Chronic pelvic pain
Female infertilityFemale infertility
Vulvodynia Vulvodynia
Aggravated by
Harmful biological effects of ionizing radiation
Harmful biological effects of ionizing radiation
EndometriosisEndometriosis
Fractures
Fractures
Intestinal obstructionIntestinal obstruction
InflammationInflammation
Unnecessary gynaecological surgeryUnnecessary gynaecological surgery
Inflammatory bowel disease
Inflammatory bowel disease
Reduces
Reduced by
Strategies
Human development
Values
Source:
Type classification:
(E) Emanations of other problems
SOURCE
http://www.diversitas.org/db/x.php?dbcode=pr&go=e&id=12065000
Wednesday, January 09, 2008
Connection Between Job Loss And Poor Health Confirmed By New Research
Employees who lose their jobs because of their health suffer more significant depression and detrimental health outcomes than people who lose their jobs for non-health reasons, new research shows. The study also suggests that people who are reemployed quickly have better health outcomes than those who remain unemployed...
Physicians Gain New Tool To Better Manage Acute And Chronic Pain
Higher Medicare Spending Yields Mixed Bag For Patients
AMA Uninsured Campaign Kicks Into High Gear With National Advertising, USA
Trust Me, Although I'm Not A Doctor, UK
Nektar Commences Phase 2 Clinical Development Program For NKTR-102 (PEG-Irinotecan) In Colorectal Cancer
Nektar Commences Phase 2 Trial Of NKTR-118 (oral PEG-naloxol) Evaluating Efficacy And Safety As Treatment For Opioid-Induced Bowel Dysfunction
Brain Response Differences Found In The Way Women With IBS Anticipate And React To Pain
Employees who lose their jobs because of their health suffer more significant depression and detrimental health outcomes than people who lose their jobs for non-health reasons, new research shows. The study also suggests that people who are reemployed quickly have better health outcomes than those who remain unemployed...
Physicians Gain New Tool To Better Manage Acute And Chronic Pain
Higher Medicare Spending Yields Mixed Bag For Patients
AMA Uninsured Campaign Kicks Into High Gear With National Advertising, USA
Trust Me, Although I'm Not A Doctor, UK
Nektar Commences Phase 2 Clinical Development Program For NKTR-102 (PEG-Irinotecan) In Colorectal Cancer
Nektar Commences Phase 2 Trial Of NKTR-118 (oral PEG-naloxol) Evaluating Efficacy And Safety As Treatment For Opioid-Induced Bowel Dysfunction
Brain Response Differences Found In The Way Women With IBS Anticipate And React To Pain
Tuesday, January 08, 2008
Adhesions Medical Headlines ARDvark Blog
Cardiovascular Sciences get $1M capital investmentBizjournals.com, NC - 17 hours agoAdhesions occur when two injured and adjacent tissues attach as part of the healing process. If this process occurs between internal organs or tissues that .....
CMS Issues Proposed Rule To Expand Plan Choices To Medicare Beneficiaries With Limited Incomes And Resources, USA
The Centers for Medicare & Medicaid Services (CMS) announced a proposed regulation that aims to allow more Medicare beneficiaries with limited income and resources to remain in the Medicare prescription drug plan in which they are enrolled without having to pay a premium...
Memory Consolidation Improved By Daytime Sleep
ASPS Survey Taps Top Markets For Regional Plastic Surgery Data
Microneedles Ease Intravenous Drug Delivery
PSNC Responds To Consultation On Stoma And Incontinence Appliances
FDA Clears First Quick Test For Drug-Resistant Staph Infections
NHS Could Save Millions If People With MRSA Were Treated At Home, Report
Home Treatment Of Pneumonia Safe And Effective, Finds Study
AARP Seeks U.S. Supreme Court Ruling That EEOC Lacks Authority To Allow Employers To Reduce Health Care Benefits For Medicare-Eligible Retirees
Three-Year Registry Data From 1,278 Women Shows Long-Term Efficacy For Uterine Fibroid Embolization (UFE)
Fifth Annual Gastrointestinal Cancers Symposium Press Program Announced
Cost Benefit Analysis In Spinal Surgery: Is It Feasable?
World Health Organization (WHO) Collaborating Centre For Patient Safety Seeks Comment On Proposed New International Patient Safety Solutions
Many Physicians Prescribe Placebos To Patients, Study Finds
Hospitalizations For GERD Up By 103 Percent
CMS Issues Proposed Rule To Expand Plan Choices To Medicare Beneficiaries With Limited Incomes And Resources, USA
The Centers for Medicare & Medicaid Services (CMS) announced a proposed regulation that aims to allow more Medicare beneficiaries with limited income and resources to remain in the Medicare prescription drug plan in which they are enrolled without having to pay a premium...
Memory Consolidation Improved By Daytime Sleep
ASPS Survey Taps Top Markets For Regional Plastic Surgery Data
Microneedles Ease Intravenous Drug Delivery
PSNC Responds To Consultation On Stoma And Incontinence Appliances
FDA Clears First Quick Test For Drug-Resistant Staph Infections
NHS Could Save Millions If People With MRSA Were Treated At Home, Report
Home Treatment Of Pneumonia Safe And Effective, Finds Study
AARP Seeks U.S. Supreme Court Ruling That EEOC Lacks Authority To Allow Employers To Reduce Health Care Benefits For Medicare-Eligible Retirees
Three-Year Registry Data From 1,278 Women Shows Long-Term Efficacy For Uterine Fibroid Embolization (UFE)
Fifth Annual Gastrointestinal Cancers Symposium Press Program Announced
Cost Benefit Analysis In Spinal Surgery: Is It Feasable?
World Health Organization (WHO) Collaborating Centre For Patient Safety Seeks Comment On Proposed New International Patient Safety Solutions
Many Physicians Prescribe Placebos To Patients, Study Finds
Hospitalizations For GERD Up By 103 Percent
Glen Beck speaks out about health "care"
Hospitals Gone Bad
Glen Beck
January 7, 2008 - 3:00 ET
Last week I made a video on YouTube and I didn't think that it would be something that would be so huge. I didn't think that it would be -- you know, it was the number two video watched over the last few days on YouTube. I mean, why, I don't know. Maybe because I was honest in a world where most people aren't, I guess. Most people like me, I'm honest, and I shared with you a bit of the story of what happened to me. I believe if I haven't had listened to promptings, I'd be dead today. I also learned an awful lot about compassion. I went into the hospital and -- well, let me give you the story from the beginning.
It was the day after Christmas. I went in for just regular surgery and I went into a place that's not even -- I mean, this used to be a two- or three-day hospital stay but because better living through pharmaceuticals, I'm sorry, better living through HMOs, we no longer put people in the hospital for this. Nothing has changed. We just don't pay for it anymore. So congratulations on that. You get to go home right after the surgery
So I went to this place and I'm going to name names. My doctors are Littlejohn and McClain from Stamford, Connecticut and they are the best of the best. These guys are absolutely amazing. I have the best team of doctors you can imagine. So Littlejohn and McClain, I go in and they're performing the surgery and McClain is, you know, the guy with the knife and the anesthesiologist, he's there and he puts me under and I'm at this place called the Tully Hall Center. The nurse, when I first walk in, the first thing I say to her after about ten minutes of talking to me, I said, can I tell you something? Already this experience is the best experience because I am so nervous about all of this stuff and you've made me feel so good about everything. She was just fantastic. And I had a great experience. I go in, I go under.
Now, this is where it starts to go awry. Starts to go awry after the surgery. The anesthesiologist told me later, he said, I didn't want want to say anything but this is the worst case I've ever seen. He said, and I've never had anybody wake up on the table before.
Read the rest.......
Glen Beck
January 7, 2008 - 3:00 ET
Last week I made a video on YouTube and I didn't think that it would be something that would be so huge. I didn't think that it would be -- you know, it was the number two video watched over the last few days on YouTube. I mean, why, I don't know. Maybe because I was honest in a world where most people aren't, I guess. Most people like me, I'm honest, and I shared with you a bit of the story of what happened to me. I believe if I haven't had listened to promptings, I'd be dead today. I also learned an awful lot about compassion. I went into the hospital and -- well, let me give you the story from the beginning.
It was the day after Christmas. I went in for just regular surgery and I went into a place that's not even -- I mean, this used to be a two- or three-day hospital stay but because better living through pharmaceuticals, I'm sorry, better living through HMOs, we no longer put people in the hospital for this. Nothing has changed. We just don't pay for it anymore. So congratulations on that. You get to go home right after the surgery
So I went to this place and I'm going to name names. My doctors are Littlejohn and McClain from Stamford, Connecticut and they are the best of the best. These guys are absolutely amazing. I have the best team of doctors you can imagine. So Littlejohn and McClain, I go in and they're performing the surgery and McClain is, you know, the guy with the knife and the anesthesiologist, he's there and he puts me under and I'm at this place called the Tully Hall Center. The nurse, when I first walk in, the first thing I say to her after about ten minutes of talking to me, I said, can I tell you something? Already this experience is the best experience because I am so nervous about all of this stuff and you've made me feel so good about everything. She was just fantastic. And I had a great experience. I go in, I go under.
Now, this is where it starts to go awry. Starts to go awry after the surgery. The anesthesiologist told me later, he said, I didn't want want to say anything but this is the worst case I've ever seen. He said, and I've never had anybody wake up on the table before.
Read the rest.......
Sunday, January 06, 2008
Can Adhesions be Prevented?
Although adhesions often form after gynecologic surgery, they are not inevitable. And, even if adhesions do form, they usually don’t cause pain or other problems.
Although there is no way to eliminate the risk of adhesions completely, there are steps your surgeon can take to reduce the likelihood of adhesion formation.
The most effective methods of adhesion prevention involve meticulous surgical technique and the use of a physical barrier to separate tissue surfaces while they heal.
Surgeons have developed minimally invasive techniques such as the laparoscopy that are designed to minimize trauma, blood loss, infection and the introduction of foreign bodies, all of which can lead to inflammation and adhesion formation.
Good surgical technique involves minimizing tissue handling, using delicate instruments, and keeping the tissues moist when they are exposed to the air.
While good surgical technique is important, but it is often not sufficient to prevent adhesions.
There are also other preventive steps that can be taken:
Surgical techniques that can help decrease adhesion formation.
Not simply the surgical procedure used, but in combination with these techniques and the lesser of invasive surgery, a laporoscopy, one has the best chance of adhesion reduction when these are used together in a surgery!
Achieve meticulous hemostasis
Maintain vascularity
Moisten tissues
Avoid dry sponges
Minimize tissue handling
Use fine, non-reactive sutures
Avoid peritoneal grafts
Minimize foreign bodies
Even though the most meticulous surgical and microsurgical techniques cannot eliminate the formation of adhesions, the following steps can be taken to reduce adhesion formation:
Achieve meticulous hemostasis: Inadequate hemostasis and the resultant fibrin deposition promote adhesion formation.
Maintain vascularity: Limiting ischemia supports fibrinolysis.
Moisten tissues: Frequent irrigation and the use of moist sponges prevent desiccation of tissue. Ringer's lactate or other irrigating solutions also eliminate any residual talc, lint, or blood clots, which may provide a nidus for a foreign body reaction, inflammation, and adhesion formation.
Avoid dry sponges: Use of gauze and dry sponges should be avoided because they may damage the peritoneal surface and leave a foreign body behind.
Minimize tissue handling: Manipulating tissue increases the possibility of vascular and tissue damage. When direct manipulation of the peritoneum is necessary, use either atraumatic instruments or fingers. In addition, cutting and coagulating should be kept to a minimum to reduce the possibility of trauma and maintain vascularity.
Use fine, nonreactive sutures: To minimize foreign body reactions use the smallest size of suture composed of synthetic material.
Avoid peritoneal grafts: Grafting increases the risk of peritoneal trauma while decreasing vascularity.
Minimize foreign bodies: Foreign bodies may damage the peritoneal surface, lead to inflammation, and ultimately result in adhesion formation.
CONSIDERING SURGERY?
If surgery is recommended for you, it's important to know what your options are and what questions to ask your primary-care physician and surgeon. If you learn all you can, you'll be sure that you're making the right decision.
Jason Bodzin, M.D., F.A.C.S., director of the Inflammatory Bowel Disease (IBD) Institute at Sinai Hospital in Detroit, advises you to follow a four-step process:
Examine your options.
Talk to your surgeon.
Talk to patients who have had the operation.
Weigh all the factors in making your decision.
Knowing What to Ask Before consenting to surgery, the first question you should ask is:
"Is this surgery necessary, or are there other medical options that I can try?"
For instance, many people with IBD have avoided surgery by combining total parenteral nutrition (intravenous feeding) with medications. 6-MP, an immunomodulator drug, often successfully heals fistulas that once required surgery.
You'll also want to know:
Are there other surgical options?
What risks will I face by having the operation?
How will the operation improve my condition?
How long will my recovery take?
Will I require medications following surgery?
Whom do you recommend as a surgeon? As anesthesiologist?
Choosing a Surgeon
Many sources can help you find a surgeon:
Friends, relatives, neighbors
Your primary-care physician
American Board of Medical Specialties (ABMS): (800) 776-CERT. (The ABMS can tell you whether a surgeon is board-certified.)
American College of Surgeons: (312) 664-4050, Ext. 391
The American Society of Colon and Rectal Surgeons: (708) 290-9184
Your local CCFA chapter
Your health insurance carrier
Your local hospital, or your state or county medical association -- all can provide lists of board-certified surgeons. Once you've compiled a list of two or three possible surgeons, ask the following questions about each one:
Is he experienced with the particular operation you need? (This is particularly important if you are undergoing a fairly new procedure, such as an ileoanal anastomosis.)
Does she treat many IBD patients?
Is he affliated with the hospital you want to be in?
Is she affiliated with a medical school or is she a member of its clinical faculty?
You'll also want to know:
Where the surgeon trained, what his specialization is, and whether he belongs to any professional organizations or has published any professional articles. (To get this information, ask the surgeon directly or go to the library.)
Whether the hospital frequently performs your kind of surgery and whether the staff is well-versed in IBD.
Getting a Second Opinion:
It is always wise to get a second opinion. In fact, many insurance companies require it. Before seeking a second opinion, you may want to get copies of all your medical records. However, any physician can request these for you.
If you receive conflicting opinions, visit a third surgeon or review the situation with your primary-care physician.
Though this process can be frustrating and time-consuming, it will give you peace of mind.
Although there is no way to eliminate the risk of adhesions completely, there are steps your surgeon can take to reduce the likelihood of adhesion formation.
The most effective methods of adhesion prevention involve meticulous surgical technique and the use of a physical barrier to separate tissue surfaces while they heal.
Surgeons have developed minimally invasive techniques such as the laparoscopy that are designed to minimize trauma, blood loss, infection and the introduction of foreign bodies, all of which can lead to inflammation and adhesion formation.
Good surgical technique involves minimizing tissue handling, using delicate instruments, and keeping the tissues moist when they are exposed to the air.
While good surgical technique is important, but it is often not sufficient to prevent adhesions.
There are also other preventive steps that can be taken:
Surgical techniques that can help decrease adhesion formation.
Not simply the surgical procedure used, but in combination with these techniques and the lesser of invasive surgery, a laporoscopy, one has the best chance of adhesion reduction when these are used together in a surgery!
Achieve meticulous hemostasis
Maintain vascularity
Moisten tissues
Avoid dry sponges
Minimize tissue handling
Use fine, non-reactive sutures
Avoid peritoneal grafts
Minimize foreign bodies
Even though the most meticulous surgical and microsurgical techniques cannot eliminate the formation of adhesions, the following steps can be taken to reduce adhesion formation:
Achieve meticulous hemostasis: Inadequate hemostasis and the resultant fibrin deposition promote adhesion formation.
Maintain vascularity: Limiting ischemia supports fibrinolysis.
Moisten tissues: Frequent irrigation and the use of moist sponges prevent desiccation of tissue. Ringer's lactate or other irrigating solutions also eliminate any residual talc, lint, or blood clots, which may provide a nidus for a foreign body reaction, inflammation, and adhesion formation.
Avoid dry sponges: Use of gauze and dry sponges should be avoided because they may damage the peritoneal surface and leave a foreign body behind.
Minimize tissue handling: Manipulating tissue increases the possibility of vascular and tissue damage. When direct manipulation of the peritoneum is necessary, use either atraumatic instruments or fingers. In addition, cutting and coagulating should be kept to a minimum to reduce the possibility of trauma and maintain vascularity.
Use fine, nonreactive sutures: To minimize foreign body reactions use the smallest size of suture composed of synthetic material.
Avoid peritoneal grafts: Grafting increases the risk of peritoneal trauma while decreasing vascularity.
Minimize foreign bodies: Foreign bodies may damage the peritoneal surface, lead to inflammation, and ultimately result in adhesion formation.
CONSIDERING SURGERY?
If surgery is recommended for you, it's important to know what your options are and what questions to ask your primary-care physician and surgeon. If you learn all you can, you'll be sure that you're making the right decision.
Jason Bodzin, M.D., F.A.C.S., director of the Inflammatory Bowel Disease (IBD) Institute at Sinai Hospital in Detroit, advises you to follow a four-step process:
Examine your options.
Talk to your surgeon.
Talk to patients who have had the operation.
Weigh all the factors in making your decision.
Knowing What to Ask Before consenting to surgery, the first question you should ask is:
"Is this surgery necessary, or are there other medical options that I can try?"
For instance, many people with IBD have avoided surgery by combining total parenteral nutrition (intravenous feeding) with medications. 6-MP, an immunomodulator drug, often successfully heals fistulas that once required surgery.
You'll also want to know:
Are there other surgical options?
What risks will I face by having the operation?
How will the operation improve my condition?
How long will my recovery take?
Will I require medications following surgery?
Whom do you recommend as a surgeon? As anesthesiologist?
Choosing a Surgeon
Many sources can help you find a surgeon:
Friends, relatives, neighbors
Your primary-care physician
American Board of Medical Specialties (ABMS): (800) 776-CERT. (The ABMS can tell you whether a surgeon is board-certified.)
American College of Surgeons: (312) 664-4050, Ext. 391
The American Society of Colon and Rectal Surgeons: (708) 290-9184
Your local CCFA chapter
Your health insurance carrier
Your local hospital, or your state or county medical association -- all can provide lists of board-certified surgeons. Once you've compiled a list of two or three possible surgeons, ask the following questions about each one:
Is he experienced with the particular operation you need? (This is particularly important if you are undergoing a fairly new procedure, such as an ileoanal anastomosis.)
Does she treat many IBD patients?
Is he affliated with the hospital you want to be in?
Is she affiliated with a medical school or is she a member of its clinical faculty?
You'll also want to know:
Where the surgeon trained, what his specialization is, and whether he belongs to any professional organizations or has published any professional articles. (To get this information, ask the surgeon directly or go to the library.)
Whether the hospital frequently performs your kind of surgery and whether the staff is well-versed in IBD.
Getting a Second Opinion:
It is always wise to get a second opinion. In fact, many insurance companies require it. Before seeking a second opinion, you may want to get copies of all your medical records. However, any physician can request these for you.
If you receive conflicting opinions, visit a third surgeon or review the situation with your primary-care physician.
Though this process can be frustrating and time-consuming, it will give you peace of mind.
Saturday, January 05, 2008
Pictures of adhesions
Right pelvic wall, bowel adhesions
Right pelvic wall, the bowel is completely adherent to the pelvic wall
Right pelvic wall after complete adhesiolysis, left the ovary can be recognized
The pelvic area after application of SprayGel™
The pelvic area at the second-look laparoscopy at day 7 postoperative, left one can see the ovary.These are suspose to be my pics from Endogyn ......but heck, who knows.
Adhesions Medical Headlines ARDvark Blog
Menopausal Anxiety, Stress And Depression Eased By Walking
Catheter Chaos: Hospitals Lag In Preventing Common Infection
Rib-X Pharmaceuticals Initiates Two Phase 2 Studies For Novel Antibiotic Compound RX-1741
Innocoll Announces Dosing Of First Patient In US Phase 2 Clinical Trial To Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT
Placebos Recommended Routinely By Doctors, Study
Insured, Wealthier Patients More Likely To Receive No-Cost Prescription Drug Samples From Physicians, According To Study
Opinion Pieces Discuss Health Care Proposals From Presidential Candidates
Recent Studies Indicate Lack Of Health Insurance 'Seriously Harmful' To Health, Editorial States
Massachusetts Department Of Revenue Releases Draft Regulations That Would Increase Penalties For Uninsured Residents ~ Gee thanks Mitt Romney!
Enhance Healing Through Guided Imagery
Catheter Chaos: Hospitals Lag In Preventing Common Infection
Rib-X Pharmaceuticals Initiates Two Phase 2 Studies For Novel Antibiotic Compound RX-1741
Innocoll Announces Dosing Of First Patient In US Phase 2 Clinical Trial To Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT
Placebos Recommended Routinely By Doctors, Study
Insured, Wealthier Patients More Likely To Receive No-Cost Prescription Drug Samples From Physicians, According To Study
Opinion Pieces Discuss Health Care Proposals From Presidential Candidates
Recent Studies Indicate Lack Of Health Insurance 'Seriously Harmful' To Health, Editorial States
Massachusetts Department Of Revenue Releases Draft Regulations That Would Increase Penalties For Uninsured Residents ~ Gee thanks Mitt Romney!
Enhance Healing Through Guided Imagery
Issue of Drugs and Pain Strikes a Nerve
Amid Painkiller Abuse Fears, Those With Legitimate Need Sometimes Go Without
By LEAH BETH WARDYakima Herald-Republic
Jan. 3, 2008—
YAKIMA, Wash. (AP) - Alex Four-Horns leans forward as far as his aching body will allow while his pain nurse massages a mixture of castor oil, ginger and lavender into his shoulder.
Castor oil has a soothing effect, giving Four-Horns some short-term relief from chronic pain, the result of a life-threatening automobile accident three years ago that left him in a coma for a month, broke both his thigh bones and damaged his knees and hips.
Once a strong, athletic man, Four-Horns, 29, now moves slowly, and he finds it difficult to keep up with his sons, ages 2 and 8. "My hip went out when I was putting up the Christmas tree with my boys," he said.
Healing oils, a lot of ibuprofen and occasional electrical nerve stimulation are the only pain management tools available to Four-Horns.
The state Medicaid program pays for occasional visits from nurse Dionetta Hudzinski to his home not far from downtown Yakima. Hudzinski, who has long been active in advocating for people with chronic pain, wonders if he might benefit from a prescription painkiller. But she can't find a doctor to treat him for pain.
Four-Horns' case illustrates what University of California pain physician Dr. Scott Fishman calls a war between two urgent public health problems -- the need to address many patients' undertreated and untreated chronic pain and the need to reduce the nation's alarming rate of prescription drug abuse.
Washington state became a battlefront in the pain war earlier this year when a group of state agency medical directors, led by Dr. Gary Franklin of the Department of Labor and Industries and in consultation with practicing pain specialists, issued voluntary guidelines to physicians for prescribing opioids for noncancer pain. Opioids such as OxyContin are powerful painkillers that mimic morphine. Heroin is made from morphine.
The state's chief recommendation is that doctors limit the total opioid dose to the equivalent of 120 milligrams of morphine a day. At that level, the state urges doctors to seek a consultation with a pain management specialist. No other state recommends a dosing limit, although others are exploring the idea.
The dosing guideline is about half the maximum average daily dose of 250 milligrams taken in recent years by injured workers and Medicaid clients with chronic, noncancer pain, according to Franklin. Doses in some cases exceeded 1,000 milligrams, he said. In contrast, some cancer specialists say their patients with chronic pain might require more than 600 milligrams of morphine a day.
Since the guidelines were published in March, they have become a flashpoint in the national debate over finding the balance between treating pain and stopping the illegal diversion of prescription painkillers into street drugs. The American Academy of Pain Medicine, an association of pain physicians, recently came out strongly against the guidelines, warning that they will scare doctors away from legitimately treating chronic pain. They attack the 120 mg dosing limit as unscientific and say there simply aren't enough pain specialists to take referrals from family doctors.
Read More
http://abcnews.go.com/print?id=4080873
By LEAH BETH WARDYakima Herald-Republic
Jan. 3, 2008—
YAKIMA, Wash. (AP) - Alex Four-Horns leans forward as far as his aching body will allow while his pain nurse massages a mixture of castor oil, ginger and lavender into his shoulder.
Castor oil has a soothing effect, giving Four-Horns some short-term relief from chronic pain, the result of a life-threatening automobile accident three years ago that left him in a coma for a month, broke both his thigh bones and damaged his knees and hips.
Once a strong, athletic man, Four-Horns, 29, now moves slowly, and he finds it difficult to keep up with his sons, ages 2 and 8. "My hip went out when I was putting up the Christmas tree with my boys," he said.
Healing oils, a lot of ibuprofen and occasional electrical nerve stimulation are the only pain management tools available to Four-Horns.
The state Medicaid program pays for occasional visits from nurse Dionetta Hudzinski to his home not far from downtown Yakima. Hudzinski, who has long been active in advocating for people with chronic pain, wonders if he might benefit from a prescription painkiller. But she can't find a doctor to treat him for pain.
Four-Horns' case illustrates what University of California pain physician Dr. Scott Fishman calls a war between two urgent public health problems -- the need to address many patients' undertreated and untreated chronic pain and the need to reduce the nation's alarming rate of prescription drug abuse.
Washington state became a battlefront in the pain war earlier this year when a group of state agency medical directors, led by Dr. Gary Franklin of the Department of Labor and Industries and in consultation with practicing pain specialists, issued voluntary guidelines to physicians for prescribing opioids for noncancer pain. Opioids such as OxyContin are powerful painkillers that mimic morphine. Heroin is made from morphine.
The state's chief recommendation is that doctors limit the total opioid dose to the equivalent of 120 milligrams of morphine a day. At that level, the state urges doctors to seek a consultation with a pain management specialist. No other state recommends a dosing limit, although others are exploring the idea.
The dosing guideline is about half the maximum average daily dose of 250 milligrams taken in recent years by injured workers and Medicaid clients with chronic, noncancer pain, according to Franklin. Doses in some cases exceeded 1,000 milligrams, he said. In contrast, some cancer specialists say their patients with chronic pain might require more than 600 milligrams of morphine a day.
Since the guidelines were published in March, they have become a flashpoint in the national debate over finding the balance between treating pain and stopping the illegal diversion of prescription painkillers into street drugs. The American Academy of Pain Medicine, an association of pain physicians, recently came out strongly against the guidelines, warning that they will scare doctors away from legitimately treating chronic pain. They attack the 120 mg dosing limit as unscientific and say there simply aren't enough pain specialists to take referrals from family doctors.
Read More
http://abcnews.go.com/print?id=4080873
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