Harold Ellis CBE FRCS
Human Sciences Research, King's College London, Hodgkin Building, Guy's Hospital Campus, London SE1 1UL, UK
SUMMARY
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES Postoperative adhesions are an almost invariable consequence of abdominal and pelvic surgery. Their most important morbidity is small-bowel obstruction, but other sequelae include female infertility and dyspareunia and increased risk of visceral injury at subsequent laparotomy or laparoscopy. Whether chronic abdominal pain is truly a consequence of adhesions is debatable, although it is likely to be accepted as an entity by both patients and their legal advisors. Of 14 successful claims dealt with by a British medical defence organization, 5 were for perforations after laparoscopic division of adhesions, 2 for adhesions after laparoscopic surgery, 1 for infertility as a result of adhesions and 6 for delayed diagnosis of obstruction. General practitioners, surgeons and gynaecologists need to be aware of the increasing burden of medicolegal claims arising from these complications.
INTRODUCTION
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES Complications resulting from postoperative intra-abdominal adhesions have been the subject of increasing medicolegal litigation, but hard facts are not easily obtained. Repeated letters to the National Health Service Litigation Authority, which is the body responsible for all NHS hospital litigation since January 1990, have not been acknowledged. However, I have been greatly helped by Dr Stephen Green, of the Medical Defence Union, and by Dr Jane Cowan, of the Medical Protection Society, who have provided details of patients' claims and complaints that have reached these organizations in recent years. Although this information is confined to claims made against general practitioners in the public and private sectors and against surgeons and gynaecologists in private practice, it does provide a picture of litigation resulting from the consequences of abdominal adhesions over the past decade.
Adhesions are almost invariable after abdominal surgery. In our review of 210 laparotomies on patients who had undergone one or more previous abdominal operations, 94% had adhesions; the exceptions were patients who had undergone lower segment caesarean section or elective appendicectomy1. Today, abdominal surgery is extremely common in the western world. In 2645 necropsies, Robert Beart, at the University of Southern California in Los Angeles, found evidence of previous abdominal operations, in 32%—a figure that rose to 44% in those over sixty years of age (Personal communication). We can infer, therefore, that nearly one-third of the adult population have intra-abdominal adhesions. The great majority of these are entirely symptomless; however, even a low morbidity in such a large group of the population will result in a considerable surgical workload.
FREQUENCY OF INTESTINAL OBSTRUCTION
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES Far and away the most important morbidity from adhesions is the development of acute intestinal obstruction. Indeed, adhesions are responsible for between 60% and 70% of all cases of small-bowel obstruction in the western world2. In our own study of 2708 laparotomies, 1% of the patients required surgery for adhesive obstruction within a year of surgery, half of these within the first four weeks. There is also a long-term risk of this complication; of 80 patients admitted with adhesive obstruction, 17 (21%) had had their initial laparotomy ten years or more previously1.
We have reported3 a study of the entire population of Scotland, some five million, based on figures obtained from the Scottish NHS medical record linkage database in Edinburgh. Patients were identified who had undergone open abdominal or pelvic surgery in 1986 and who had no record of such surgery in the preceding five years. These patients were followed up for ten years. Of the 29 790 patients studied, 5.7% were readmitted with complications directly consequent on adhesions, of which 3.8% required surgery. Of these readmissions, 22.1% occurred in the first year after the initial surgery, but the remainder of readmissions continued steadily over the ten-year period.
MEDICOLEGAL CONSEQUENCES
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES The following, in order of frequency, are the topics that, in recent years have led to complaints and claims against medical practitioners: failure of diagnosis, or delay in diagnosis; bowel damage at adhesiolysis (at laparoscopy more than at laparotomy); chronic abdominal or pelvic pain; infertility or risk of infertility; starch granuloma consequent upon use of starch-powdered gloves; and failure to take precautions to prevent adhesion formation.
Between 1989 and 1999, the Medical Protection Society dealt with 13 claims in which adhesions had been implicated. 9 of these involved general practitioners; in all of them the complaint was of delayed or failed diagnosis. 3 claims were made against gynaecologists—one for failure to diagnose and two for bowel damage at adhesiolysis (one at surgery, the other at laparoscopy). The final case involving a surgeon was, again, bowel damage at operative division of adhesions.
The Medical Defence Union was able to supply more comprehensive information. This organization has a membership of some 22 000 general practitioners, 500 gynaecologists and 720 general/vascular surgeons. Over the six years 1994-1999 it received 77 claims pertaining to abdominal adhesions, as follows: failure to diagnose or delay in diagnosis, 21; visceral injury at laparoscopy, 12; visceral injury at laparotomy, 10; pain, dyspareunia, infertility, 7; failure to use ‘Sepracoat’, 1; failure to warn of risk, 1; and various (including death during adhesiolysis, miscarriage following), 25.
Over an eleven-year period, 14 cases were settled out of court by the Medical Defence Union, the range being £7960-124 261, average per case £50 765. These 14 cases comprised:
Perforations after laparoscopic division of adhesions, 5
Adhesions after laparoscopic surgery, 2
Infertility as a result of adhesions, 1
Delayed diagnosis of obstruction, 6
STARCH GRANULOMAS
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES Cases of intra-abdominal starch granulomas, often presenting as postoperative intestinal obstruction, were extensively reported in the 1960s4, resulting from the starch on surgical gloves. Since 1971 the US Food and Drug Administration have required warnings of the starch hazard on glove packets, and since 1983 powder-free gloves have been commercially available. Because of the almost universal use of such gloves in the UK, there seem to have been no cases of litigation on this count. There were three court cases concerning starch granulomas in the USA in 1969, 1970 and 1974.
WHAT ARE THE LESSONS TO BE LEARNED?
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES Surgeons, gynaecologists and general practitioners must be alert to the possibility that obstructive symptoms early and late after abdominal surgery are likely to be caused by adhesions. Delayed diagnosis can result in gangrene and even perforation of the strangulated bowel, with substantial morbidity and mortality.
The question of chronic abdominal pain as a result of adhesions is a difficult one. The clinical features of acute and of recurrent subacute intestinal obstruction are well known. Whether ‘grumbling’ abdominal pain can result directly from adhesions is debatable. Most surgeons in the UK doubt the organic basis of this syndrome, which is particularly seen after gynaecological surgery. Clearly, millions of people with postoperative adhesions remain pain-free for life. However, the judiciary are more likely to believe post hoc, propter hoc and to side with the complainant. It is easier to understand how a tethered ovary in the pelvis might result in dyspareunia.
The risk of visceral injury, especially of gut perforation, when adhesions are divided at reoperation has lately been quantified in a retrospective study. Workers from the University Hospital at Nijmegen5 showed that inadvertent enterotomy occurred in no fewer than 52 (19%) of 270 patients undergoing relaparotomy, with 7 deaths (13%) compared with 16 (7%) in the remaining 218 patients. Independent risk factors for injury to the bowel were obesity, age and three or more previous laparotomies. A similar study of incidence and risk factors for laparoscopic adhesiolysis would be welcome. Clearly, patients need to be warned of this danger preoperatively and surgeons need to be alert to it, ready for immediate repair of any injury. For injuries sustained at laparoscopy, this will mean conversion to an open operation.
Although adhesion formation is almost invariable after laparotomy, surgeons should take all reasonable precautions to limit its extent and, in particular, try to prevent adhesions to small intestine with their risk of bowel obstruction. Starch-powdered gloves must be avoided. Peritoneal defects and the pelvic floor should be left open since these rapidly reperitonealize. Anastomoses should be covered by omentum, which should be drawn down under the inner aspect of the laparotomy incision. There is obvious need for the development of effective and safe antiadhesion agents.
REFERENCES
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES
Menzies D, Ellis H. Intestinal obstruction from adhesions; how big is the problem? Ann R Coll Surg Engl1990; 72:60 -3[Medline]
Ellis H. The magnitude of adhesion related problems. Ann Chir Gynaecol 1998;87:9 -11[Medline]
Ellis H, Morgan BJ, Thompson JN, et al. Adhesion related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet1999; 353:1476 -80[Medline]
Ellis H. Pathological changes produced by surgical dusting powders. Ann R Coll Surg Engl1994; 76:5 -8[Medline]
Van der Krabben AA, Dijkstra FR, Nieuwenhuijzen M, et al. Morbidity and mortality of inadvertent enterotomy during adhesiotomy. Br J Surg2000; 87:467 -71[Medline]
Tuesday, April 29, 2008
Agencies Team Up in War Against Internet Health Fraud
by Linda Bren
…cures Alzheimer's and HIV/AIDS…proven effective in treating over 650 infectious diseases…recognized in scientific journals to be a revolutionary breakthrough in treating arthritis
These health product claims found on the Internet can provide hope for those suffering from painful or debilitating diseases. But they are false claims, leading to false hopes. They are also fraudulent, illegal, and the cause of recent government enforcement actions against the companies that made them.
In the ongoing war against Internet health fraud, federal and state government organizations have united, in an effort dubbed Operation Cure.All, to crack down on unscrupulous marketers who use the Internet to prey on the sickest and most vulnerable consumers.
Operation Cure.All, a partnership of the Federal Trade Commission, the Food and Drug Administration, Health Canada (the Canadian federal health department), and various state attorneys general and state health departments, combines a law enforcement effort with a consumer education campaign.
Almost 100 million adults in the United States use the Internet to find health-related information, according to a poll conducted by the market research firm Harris Interactive. "The Internet provides many benefits. But, its unique qualities--including its broad reach, relative anonymity, and ease of creating new Web sites or removing old ones--pose new enforcement challenges," says Bernard A. Schwetz, D.V.M., Ph.D., acting principal deputy commissioner of the FDA. "FDA and the FTC are working together to protect the public from those who try to take advantage of consumers through this new technology."
In June, the FTC, which developed and leads Operation Cure.All, announced enforcement actions against six companies that fraudulently marketed health products on the Internet. These actions mark Operation Cure.All's fourth group of targeted enforcement efforts to address marketing of unproven health products on the Internet.
Five of the companies have agreed to settle the charges. Settlements included such actions as removal of all unsubstantiated claims for products, warnings about potential dangerous interactions with some prescription drugs, a notice to purchasers with an offer for a full refund, and agreement to pay fines for consumer redress. The FTC has filed a complaint in federal district court against the sixth company.
Among the many false and unsubstantiated claims challenged in these recent cases were promises that:
People could cancel their surgery, radiation or chemotherapy in favor of herbal cures that cost hundreds of dollars;
A device that delivered mild electric current would kill the parasites that cause such serious diseases as cancer and Alzheimer's; and
Those with HIV or AIDS could use St. John's wort as a safe treatment for the disease. (The FDA and FTC warn that St. John's wort may have potentially dangerous interactions with other medications, including some proven HIV/AIDS medications.)
"It's bad enough when someone, with little or no evidence, touts unproven remedies to vulnerable populations such as people infected with HIV or AIDS," says Walter H. Carr, partnership council chairman of the National AIDS Health Fraud Task Force Network. "It's even more frightening when they do so despite--and without so much as a mention of--emerging risks that those remedies pose to the very people to whom they are pitching their sale. St. John's wort and protease inhibitors: They don't mix."
Since the launch of Operation Cure.All in 1999, the FDA and FTC have won a number of battles against Internet health fraud. The FDA's efforts to curtail online marketing of unapproved drugs have resulted in at least 12 product seizures, 11 product recalls, 43 arrests, and 22 convictions. The FDA continues to investigate more than 80 incidences of Internet health fraud and unapproved drug products.
Since 1999, the FTC has brought 13 law enforcement actions against Internet marketers for unsubstantiated health claims. One case resulted in a $1 million settlement with the maker of a shark cartilage product promoted as a cure for cancer. Another settlement required consumer refunds for electronic devices and herbal remedies that were sold as cures for cancer, AIDS, Gulf War syndrome, and many other diseases. All were required to remove their bogus claims from the Web. In addition, the FTC estimates that more than 100 other Web sites have taken down their sites or removed their claims after the FTC contacted them.
"Consumers should avoid Web sites that promise quick and dramatic cures for serious diseases," says Howard Beales, director of the FTC's Bureau of Consumer Protection. "And they should always consult a physician or other health-care professional before using any product or treatment."
How to Report Suspicious Claims
The FTC and FDA encourage people to report suspicious health claims. Since January 2000, the FDA has checked out more than 3,000 tips submitted by consumers about suspicious online prescription Web sites, according to Tom McGinnis, R.Ph., the FDA's director of pharmacy affairs.
To file a complaint regarding a possible fraudulent, deceptive, or unfair business practice, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at www.ftc.gov.
If you find a Web site you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, or cosmetics over the Internet, use the complaint form at www.fda.gov/oc/buyonline/buyonlineform.htm.--L.B.
Be Suspicious
Promoters of fraudulent health-care products often use similar claims and practices to lure consumers into buying their goods. The FTC and FDA advise consumers to be suspicious of:
Claims that the product is "natural" or "non-toxic," suggesting it does not have side effects. "Natural" or "non-toxic" does not necessarily mean safe. Some "natural" supplements contain potent stimulants; others can result in negative interactions with medicines.
Testimonials from people who claim amazing results. Testimonials often are undocumented and are not a substitute for scientific proof.
Claims that a product is a "scientific breakthrough," "miraculous cure," "secret ingredient" or "ancient remedy."
Claims that the product is an effective cure for a wide range of ailments.
Claims that use impressive-sounding medical terms.
Claims that the product is available from only one source, and payment is required in advance.
Claims of a "money-back" guarantee.
Web sites that fail to list the company's name, physical address, phone number or other contact information.
--L.B.
For More Information…
For tips on buying health-care products on the Internet, check out:
FTC's Virtual Health Treatments [Note (8-6-2003): Now called Operation Cure.All]
FDA's Buying Medicines and Medical Products Online
For safety and other information on dietary supplements, see:www.cfsan.fda.gov/~dms/supplmnt.html
Table of Contents How to Subscribe Back Issues Editorial Questions
FDA/Office of Public Affairs
…cures Alzheimer's and HIV/AIDS…proven effective in treating over 650 infectious diseases…recognized in scientific journals to be a revolutionary breakthrough in treating arthritis
These health product claims found on the Internet can provide hope for those suffering from painful or debilitating diseases. But they are false claims, leading to false hopes. They are also fraudulent, illegal, and the cause of recent government enforcement actions against the companies that made them.
In the ongoing war against Internet health fraud, federal and state government organizations have united, in an effort dubbed Operation Cure.All, to crack down on unscrupulous marketers who use the Internet to prey on the sickest and most vulnerable consumers.
Operation Cure.All, a partnership of the Federal Trade Commission, the Food and Drug Administration, Health Canada (the Canadian federal health department), and various state attorneys general and state health departments, combines a law enforcement effort with a consumer education campaign.
Almost 100 million adults in the United States use the Internet to find health-related information, according to a poll conducted by the market research firm Harris Interactive. "The Internet provides many benefits. But, its unique qualities--including its broad reach, relative anonymity, and ease of creating new Web sites or removing old ones--pose new enforcement challenges," says Bernard A. Schwetz, D.V.M., Ph.D., acting principal deputy commissioner of the FDA. "FDA and the FTC are working together to protect the public from those who try to take advantage of consumers through this new technology."
In June, the FTC, which developed and leads Operation Cure.All, announced enforcement actions against six companies that fraudulently marketed health products on the Internet. These actions mark Operation Cure.All's fourth group of targeted enforcement efforts to address marketing of unproven health products on the Internet.
Five of the companies have agreed to settle the charges. Settlements included such actions as removal of all unsubstantiated claims for products, warnings about potential dangerous interactions with some prescription drugs, a notice to purchasers with an offer for a full refund, and agreement to pay fines for consumer redress. The FTC has filed a complaint in federal district court against the sixth company.
Among the many false and unsubstantiated claims challenged in these recent cases were promises that:
People could cancel their surgery, radiation or chemotherapy in favor of herbal cures that cost hundreds of dollars;
A device that delivered mild electric current would kill the parasites that cause such serious diseases as cancer and Alzheimer's; and
Those with HIV or AIDS could use St. John's wort as a safe treatment for the disease. (The FDA and FTC warn that St. John's wort may have potentially dangerous interactions with other medications, including some proven HIV/AIDS medications.)
"It's bad enough when someone, with little or no evidence, touts unproven remedies to vulnerable populations such as people infected with HIV or AIDS," says Walter H. Carr, partnership council chairman of the National AIDS Health Fraud Task Force Network. "It's even more frightening when they do so despite--and without so much as a mention of--emerging risks that those remedies pose to the very people to whom they are pitching their sale. St. John's wort and protease inhibitors: They don't mix."
Since the launch of Operation Cure.All in 1999, the FDA and FTC have won a number of battles against Internet health fraud. The FDA's efforts to curtail online marketing of unapproved drugs have resulted in at least 12 product seizures, 11 product recalls, 43 arrests, and 22 convictions. The FDA continues to investigate more than 80 incidences of Internet health fraud and unapproved drug products.
Since 1999, the FTC has brought 13 law enforcement actions against Internet marketers for unsubstantiated health claims. One case resulted in a $1 million settlement with the maker of a shark cartilage product promoted as a cure for cancer. Another settlement required consumer refunds for electronic devices and herbal remedies that were sold as cures for cancer, AIDS, Gulf War syndrome, and many other diseases. All were required to remove their bogus claims from the Web. In addition, the FTC estimates that more than 100 other Web sites have taken down their sites or removed their claims after the FTC contacted them.
"Consumers should avoid Web sites that promise quick and dramatic cures for serious diseases," says Howard Beales, director of the FTC's Bureau of Consumer Protection. "And they should always consult a physician or other health-care professional before using any product or treatment."
How to Report Suspicious Claims
The FTC and FDA encourage people to report suspicious health claims. Since January 2000, the FDA has checked out more than 3,000 tips submitted by consumers about suspicious online prescription Web sites, according to Tom McGinnis, R.Ph., the FDA's director of pharmacy affairs.
To file a complaint regarding a possible fraudulent, deceptive, or unfair business practice, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at www.ftc.gov.
If you find a Web site you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, or cosmetics over the Internet, use the complaint form at www.fda.gov/oc/buyonline/buyonlineform.htm.--L.B.
Be Suspicious
Promoters of fraudulent health-care products often use similar claims and practices to lure consumers into buying their goods. The FTC and FDA advise consumers to be suspicious of:
Claims that the product is "natural" or "non-toxic," suggesting it does not have side effects. "Natural" or "non-toxic" does not necessarily mean safe. Some "natural" supplements contain potent stimulants; others can result in negative interactions with medicines.
Testimonials from people who claim amazing results. Testimonials often are undocumented and are not a substitute for scientific proof.
Claims that a product is a "scientific breakthrough," "miraculous cure," "secret ingredient" or "ancient remedy."
Claims that the product is an effective cure for a wide range of ailments.
Claims that use impressive-sounding medical terms.
Claims that the product is available from only one source, and payment is required in advance.
Claims of a "money-back" guarantee.
Web sites that fail to list the company's name, physical address, phone number or other contact information.
--L.B.
For More Information…
For tips on buying health-care products on the Internet, check out:
FTC's Virtual Health Treatments [Note (8-6-2003): Now called Operation Cure.All]
FDA's Buying Medicines and Medical Products Online
For safety and other information on dietary supplements, see:www.cfsan.fda.gov/~dms/supplmnt.html
Table of Contents How to Subscribe Back Issues Editorial Questions
FDA/Office of Public Affairs
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New Clinical Practice Guidelines On The Treatment Of Hirsutism
Oral Prolonged Release Oxycodone / Naloxone Combination Reduces Opioid-induced Constipation In Severe Chronic Pain Patients, With No Loss Of Analgesia
Fewer General Surgeons In United States Today
Los Angeles Times Examines 'Exodus' Of Specialists From Southern California Emergency Departments
Hanys Issues "Report Card" On Hospital Report Cards
Women & Depression
Clinical Trial Results Show Proof-of-Concept For Use Of Coriolus Versicolor As Immunonutrition In HPV Patients With Cervical Lesions (LSIL)
BR Pharma Appoints Adele Davis As Head Of Clinical Trials
FDA Approves New Once-a-Month Dose Of Actonel For Postmenopausal Osteoporosis
New Advice On Treating GERD: Johns Hopkins Health Alerts Reports On The Latest Research
Brain-Gut Relationship Studied In Those Suffering With Stomach Pain Or Discomfort
FDA Approval Of Cimzia(R) For Crohn's Disease Represents Latest Milestone For Nektar's PEGylation Technology Platform
New Clinical Practice Guidelines On The Treatment Of Hirsutism
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