FDA Statement: Urgent Global Market Withdrawal: GYNECARE INTERGEL Adhesion Prevention Solution Voluntarily Withdrawn from the Market by GYNECARE Worldwide
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Urgent Global Market Withdrawal: GYNECARE INTERGEL Adhesion Prevention Solution Voluntarily Withdrawn from the Market by GYNECARE Worldwide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.