Vaginal mesh for pelvic organ prolapse: Information for healthcare professionals

• MHRA investigation into vaginal mesh implants
• Adverse events that should be reported
• Further information

Vaginal mesh implants used to treat pelvic organ prolapse (POP) include a range of different types of mesh implanted in the pelvic floor area in a number of different ways to support the vaginal wall and/or internal organs. The mesh can be synthetic, ‘biological’ or a combination of the two and it may be absorbable or non-absorbable.

Guidance and support for NHS surgeons on tape and mesh implants - Letter from Sir Bruce Keogh (external link)

Press release: Better guidance and support for NHS surgeons on vaginal tape and mesh implants (external link)

MHRA investigation into vaginal mesh implants

In light of an increasing number of adverse events and patient concerns being reported, the MHRA launched an investigation to better understand the use of these devices and the complications associated with their use.

MHRA workshop

The MHRA held a workshop in March 2012 under the chairmanship of Professor Paul Abrams, which included representatives of the Royal College of Obstetricians and Gynaecologists, the British Association of Urological Surgeons, the British Society of Urogynaecology, NICE, the University of Aberdeen Health Services Research Unit, and representatives of some manufacturers of these devices, to consider how to make this a safer procedure.

The meeting covered:

• types of vaginal mesh
• clinical experience, training and outcomes of prolapse surgery
• complications arising from the use of vaginal mesh
• NICE/IPAC guidance
• adverse event reporting
• responsibilities of involved parties (clinicians, regulators and manufacturers).

Further information on the outcomes of this workshop can be found in the section Responsibilities of the parties involved in the manufacture, regulation and surgical provision of vaginal meshes

MHRA review

In light of an increasing number of adverse events and patient concerns being reported, the MHRA launched an investigation to better understand the use of vaginal tapes/slings and meshes and the complications associated with their use.

Although MHRA have had very few reports of problems with these devices we have noted concerns about their safety that are being expressed by patients and patients’ groups. We do take the problems and issues reported very seriously and share concern for their safety, and those that have experienced unwanted complications from them.

In February 2012, the MHRA commissioned a systematic review of the available literature on the incidence of the most frequently reported adverse events associated with different meshes/tapes/slings. The results can be found on Summaries of the safety/adverse effects of vaginal meshes for prolapse

We continue to actively investigate and gathering evidence on the safety of these vaginal mesh and tape devices to better inform patients, doctors and surgeons about the risks, benefits and uses of these devices.

Adverse events that should be reported

The MHRA is still gathering information on the use and complications associated with these devices and would encourage reporting of adverse events to us.

Reporting a safety problem with a device

Adverse events related to these devices that we expect clinicians to report to us include the following:

Pre-procedural

• mesh appears unsuitable to implant e.g. rough or sharp edges; too hard or brittle; not to specification
• packaging compromised affecting sterility.

Procedural related

• tape/mesh tears or disintegrates when implanting or fixing mesh in place
• bladder perforation.

Post operatively

• patient has an unexpected severe adverse/allergic tissue reaction to the mesh
• bladder perforation.

Longer-term patient follow-up

• evidence of mesh shrinkage, disintegration, hardening, brittleness
• recurrence of prolapse
• bladder perforation
• vaginal perforation
• recurrence of stress or urge incontinence
• mesh erosion/extrusion through tissues - especially where further surgery is needed for partial or total mesh removal
• dyspareunia
• persistent pelvic/groin pain.

Further information

NHS Choices webpage on treatment for prolapse of the uterus (external link).

NICE guidance

The National Institute for Health and Clinical Excellence (NICE) has produced guidance on the use of mesh for pelvic organ prolapse, which is available on the NICE website, along with summaries of the guidance produced for patients.

For the following procedures NICE guidelines state that current evidence on the efficacy and safety of these procedures is inadequate in quantity and quality. Therefore the procedure should only be used with special arrangements for clinical governance, consent and audit or research.

Infracoccygeal sacropexy using mesh for uterine prolapse repair (IPG280)

• Interventional procedure guidance for healthcare professionals (external link).
• Summary of this guidance for patients and carers (external link).

Infracoccygeal sacropexy using mesh for vaginal vault prolapse repair (IPG281)

• Interventional procedure guidance for healthcare professionals (external link).
• Summary of this guidance for patients and carers (external link).

Insertion of mesh uterine suspension sling (including sacrohysteropexy) for uterine prolapse repair(IPG282)

• Interventional procedure guidance for healthcare professionals (external link).
• Summary of this guidance for patients and carers (external link).

Sacrocolpopexy with hysterectomy using mesh for uterine prolapse repair (IPG284)

• Interventional procedure guidance for healthcare professionals (external link).
• Summary of this guidance for patients and carers (external link).

For the procedure Sacrocolpopexy using mesh for vaginal vault prolapse repair (IPG283), current evidence on the safety and efficacy of sacrocolpopexy using mesh for vaginal vault prolapse repair appears adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance and audit.

• Interventional procedure guidance for healthcare professionals (external link).
• Summary of this guidance for patients and carers (external link).

Karen Steward and her "Business Prospects" on Facebook

Many Facebook Users Willingly Give Out Personal Information

December 8th, 2009
Facebook, Internet Safety, Online Reputation Management, Privacy, Social Networking
Rob Frappier

Karen's quote:

#1 karen on 12.11.09 at 8:39 am

Facebook was presented to me as a way to build my business via networking. Many whom I’ve befriended are also on facebook to build their business connections. With that concept, one would have to add unknown friends. Also, if someone simply googles your name, it is easy to find their address, etc. There’s lots of personal information on the internet about a person that the person did not place there themselves. So, please explain how building a network of friends on facebook is any worse than just being alive and vulnerable to GOOGLE.


http://www.reputation.com/blog/2009/12/08/many-facebook-users-willingly-give-out-personal-information/

Adhesion Awareness Giveaway Offers Over $9,700 in Prizes

By Djordje Jurinac on Aug 30, 2011
Virtually all people have adhesions (internal scars). If you scrape your knee, have a fall, undergo surgery or develop an infection, adhesions form to surround the injured area. As the body heals, adhesions often remain at the site of the trauma, surgery, infection or inflammation.


Unfortunately, they can spread to nearby organs, muscles, or nerves, causing unexplained pain or dysfunction. Small but powerful adhesions can act like nylon ropes or straight-jackets, and can cause a myriad of health problems.


Adhesions are often an underlying cause of chronic pain, female infertility, endometriosis pain, and bowel obstructions. Because they are invisible on most diagnostic tests, such as x-rays, CT and MRI scans, they often go undiagnosed by physicians and health care professionals.


Clear Passage Physical Therapy has developed and researched non-invasive treatments for adhesions for over twenty years. Their non-surgical, hands-on therapy (Wurn Technique) uses techniques that feel like a deep massage, to release adhesions that bind structures within the body. In published studies, most patients reported significant pain relief, and a return of function.


In honor of Adhesion Related Disorder (ARD) Awareness Month this September, Clear Passage will donate over $9,700 in treatment and lodging, to three prize winners. Patients who suffer from an ARD can enter this giveaway on the Clear Passage website or on their Facebook page.


The grand prize winner will receive 20 hours of free treatment at Clear Passage’s national headquarters in Gainesville, FL and five days of lodging at a lovely Florida waterfront cottage (a $6,100 value). The second prize winner will receive 10 hours of free treatment (a $2,600 value), and the third prize winner will receive 20 percent off a 20 hour treatment program (a $1,040 value).


“Diagnosing adhesions can be confusing, because they often cross body systems,” says Clear Passage National Director Belinda Wurn, PT. “Many people go from specialist to specialist, sometimes for years, simply searching for a diagnosis. Their problems increase when they learn that the surgery to remove adhesions can often create more adhesions.”


“We are pleased to offer a non-surgical alternative to patients” she said. “It’s very gratifying to give adhesion sufferers back their lives.”


About Clear Passage Physical Therapy

Clear Passage Physical Therapy is a network of high quality physical therapy clinics specializing in hands-on treatment of adhesions, chronic pain, infertility, endometriosis, and bowel obstruction.
http://eyugoslavia.com/featured/30/adhesion-awareness-giveaway-offers-over-9700-in-prizes-2223748/

ARD Education and Awareness

ARD Education and Awareness from the best educational ARD website!

http://www.adhesionrelateddisorder.com/adhesion3.html

Abdominal/Pelvic Pain Can Occur After Surgery.

Abdominal/Pelvic pain can occur after surgery. Post surgical pain can present shortly following your surgery, and usually resolves over the following days and weeks as you recover from that surgery. But some pain may linger for months or years following a surgical procedure. The question is, what is the source of this pain?
In some cases, the answer is Adhesions!
Adhesions are bands of scar tissue intra-abdominal and/or pelvic cavity that bind your internal organs together, causing them to stick to each other. The result of these bands of scar tissue can lead to:
Adhesion Related Disorder or ARD.
The symptoms of ARD include:
Chronic pain
Infertility
Bowel obstruction
Gastro-esophageal reflux disease, (GERD)
Urinary Bladder dysfunction
Pain and difficulty having a bowel movement
Pain on movement such as: Walking, sitting or laying in certain positions.
Loss of Nutrients due to poor eating habits or loss of appetite.
Loss of employment due to lost work days
Loss of family and social life
Emotional Disorders such as: Depression, Thoughts of Suicide, Hopelessness
If you are experiencing pelvic pain, it’s important to see your doctor. Pain in the pelvic or abdominal area can be caused by a variety of conditions, some of which may be serious. Your doctor will be able to perform tests to determine the cause of your pain. Do not assume all pelvic or abdominal is caused by adhesion even if your post adhesiolysis, as adhesions do reform following surgery.
It is important to ask for and allow diagnostic tests to rule out other sources of pathology as being the cause for your symptoms…while some adhesion do cause pain, not all adhesions cause pain and not all pain is caused by adhesions!
If all diagnostic tests result in negative findings, one cause of pain that your doctor might consider is adhesions, particularly if you have had abdominal or pelvic surgery. Adhesions are commonly associated with pelvic pain. In fact, an estimated 38 percent of women suffering from pelvic pain have adhesions.
The better news is that there are things that your doctor can do to reduce the incidence post-operative adhesions – and maybe even prevent them altogether. Educate yourself to “Adhesion Related Disorder” as the informed patient can make informed decisions when you discuss your symptoms and medical care needs with your doctor.
Always request and keep a personal file of all your medical interventions!




Adhesions Can Cause Pain:
Adhesions can cause pain by binding normally separate organs and tissues together - essentially “tying them down.” The stretching and pulling of everyday movements can irritate the nerves involved. Some adhesions can cause pain during intercourse. Ask your medical care provide to order an “ESR = Erythrocyte Sedimentation Rate” ‘ blood test for inflammatory reaction in your body. Inflammation at the adhesion attachment sites become agitated due to the pulling and tugging on the tissues of the attached organs. This inflammation creates pain and must be taken into consideration by the Doctor when treating the ARD sufferer for pain.
While pelvic pain can be an obvious symptom of adhesions, there are other serious complications of which you should be aware. Two of the more common complications of adhesions are infertility and bowel obstruction.


Adhesion can and do cause disabling pain and loss of productivity. You will want to resent substantiating information on this issue when you meet with your Doctor.
Be prepared, be your own best Doctor!


Bowel obstruction:
Adhesion formation involving the bowel (intestine) is particularly common following hysterectomy. These adhesions occasionally they can cause the bowel to kink and not allow the passage of digested food. This causes a “back-up.” Bowel obstruction can occur shortly after surgery or many years later. Symptoms of bowel obstruction may include pain, nausea, and vomiting. Bowel obstruction is a serious illness and requires immediate medical attention.
Even though the overall incidence of bowel obstruction is low, you should be aware of the possibility of its occurrence. If left untreated, obstruction can lead to serious complications, even death. Symptoms of bowel obstruction include:


Abdominal pain
Nausea
Vomiting
Diarrhea (early)
Constipation (late)
Fever
You should talk to your doctor if you have any of these symptoms.
Endometriosis.
One of the more common non-surgical causes of pelvic pain is endometriosis.
If you have been trying unsuccessfully to conceive, you are probably searching for the cause. Your search may have led you to this site. It’s important to understand that there are many conditions that can cause infertility, and you should talk to your doctor to determine whether your situation requires medical attention.


Adhesions that form as a result of certain types of gynecologic surgery, especially tubal surgeries and myomectomies (surgery to remove fibroids), are a common cause of infertility. Adhesions can form between the ovaries, fallopian tubes or pelvic walls.
These adhesions can block the passage of ovum (an egg) from the ovaries into and through the fallopian tubes.
Adhesions around the fallopian tubes can also interfere with sperm transport to the ovum.


Ovarian Surgery
Surgical Treatment of Endometriosis
Myomectomy
Reconstructive Tubal Surgery
The good news is that infertility due to pelvic adhesions can be successfully treated in approximately 40% to 60% of women. However, the surgical procedure, adhesiolysis, can often lead to more adhesions. The best way to reduce the chances of adhesions forming and/or reforming is for your surgeon to learn the best procedure used in the attempt to reduce adhesion formation. The more a surgeon practices the procedure, the more skilled he will become in performing it. As he develops his technique over time along with the use of an effective adhesion barrier, the better the results for improvement in the symptoms of the adhesion patient!
Talk to your doctor if you have pelvic pain of any kind.

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

Heated and Humidified gas 

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