Posted by Article on 5/6/2003, 3:32 pm
Board Administrator

I feel this is a very important article for everyone to read that may have had Gynecare Intergel used during their surgery and for the rest of us to inform ourselves about. There is an earlier article describing this product further down on this board. Sue ************** Sales of surgical gel suspended pending investigation of problems Apr. 16, 2003 Provided by: Canadian Press WASHINGTON (AP) - Worldwide sales of a surgical gel have been suspended pending investigation of reports of pain, repeat operations and even three deaths among women who received it during gynecological operations, the Food and Drug Administration said Wednesday. The FDA publicized the Gynecare Intergel withdrawal by posting on its Web site letters from the manufacturer urging that physicians stop using the surgical gel. Intergel's maker, Johnson & Johnson division Gynecare Worldwide, had suspended sales March 28. Intergel is supposed to reduce a type of internal scar tissue that forms after some pelvic operations. But Gynecare has received about 103 complaints worldwide of pain, internal scarring and repeat surgeries, FDA officials said. They said there were 72 reports from the United States, including three deaths, which the FDA is still evaluating. Spokeswoman Sharon Snider said that the reports alone did not establish any cause and effect for the problems, but merely suggested further inquiry. In some patients, when doctors reoperated they found an unexpected amber-coloured residue left inside the woman. The FDA initially deemed Intergel too risky to sell here, citing studies that found women given the gel had only one fewer internal scar but almost twice the risk of infection as women given standard treatment. But Intergel's maker appealed, and in November 2001, the FDA made an unprecedented about-face and approved Intergel after all, terming it "reasonably safe" if used only in select patients. With "many marketed products, you really don't get the true story, the full story, on a product until it's out there and it's widely used," said Tim Ulatowski, the FDA official monitoring Intergel, when asked if that decision was now proving wrong. It's too early to predict if Intergel will resume sales, he said. The gel also was sold in 22 other countries, and Gynecare called complaints low considering 80,000 doses were sold. - On the Net: FDA notice: fda.gov/medwatch/SAFETY/2003/intergel.htm *********************** Below taken from: http://www.fda.gov/medwatch/SAFETY/2003/intergel.htm 2003 Safety Alert - INTERGEL Adhesion Prevention Solution -------------------------------------------------------------------------------- This is the text of a statement from FDA Center for Devices and Radiological Health. Contact the company for a copy of any referenced enclosures. -------------------------------------------------------------------------------- Urgent Global Market Withdrawal: GYNECARE INTERGEL Adhesion Prevention Solution Voluntarily Withdrawn from the Market by GYNECARE Worldwide April 16, 2003 GYNECARE Worldwide, a division of Ethicon Inc. of Somerville, New Jersey, notified FDA that they are voluntarily withdrawing “GYNECARE INTERGEL Adhesion Prevention Solution” from the global market and are urging customers to immediately stop using this device. This product has been distributed in the following countries; Austria, Canada, Egypt, England, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Portugal, Republic of Singapore, Saudi Arabia, Scotland, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and the United States. This product is intended to be used in open, conservative gynecological surgery as an adjunct to good surgical technique to reduce post-surgical adhesions. GYNECARE is conducting this voluntary withdrawal to complete an assessment of information obtained during post-marketing experience with the device, including adverse events associated with off-label use in laparoscopy and non-conservative surgical procedures such as hysterectomy. Post-market reports include late-onset post-operative pain and repeat surgeries following the onset of pain, non-infectious foreign body reactions, and tissue adherence. In some patients a residual material was observed during the repeat surgery. Post-operative pain could be suggestive of other serious complications and physicians should be aware of this in managing patients in the post-operative period. GYNECARE is withdrawing the device from the market to conduct a full and thorough assessment of technical issues, surgical techniques and circumstances associated with the post-market events. From the launch of this device in 1998 to February 2003, the overall complaint rate worldwide is low. GYNECARE is requesting all GYNECARE INTERGEL product and samples be returned to GYNECARE. Questions about returning these products can be answered by GYNECARE sales representatives or the Customer Hotline at 1-800-551-7683. Further information can be found at: http://www.fda.gov/medwatch/safety/2003/Intergel.pdf FDA is also investigating to determine the nature of the problem and will update this webpage as information becomes available. If you become aware of a problem associated with these products, please contact MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch one of four ways: online at http://www.accessdata.fda.gov/scripts/medwatch/; by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, HFD-410, 5600 Fishers Lane, Rockville, MD 20857.

Link: Link to first article above