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Surgical Solution GYNECARE INTERGEL Linked to Serious Side Effects

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Case ID: 2334 | Drugs / Medical | 06/20/2003
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Have you had a surgery where an adhesion prevention solution (a thick liquid gel) used to separate and protect tissues as they heal caused you harm?

Kahn Gauthier Swick is investigating possible legal actions against Ethicon Inc. on behalf of women who were harmed by the use of GYNECARE INTERGEL Adhesion Prevention Solution in the course of gynecological or other surgery. GYNECARE INTERGEL is a thick liquid (gel) made of sodium hyaluronate and iron. It is used during gynecological surgery to separate and protect tissues as they heal, preventing adhesions. This product was voluntarily recalled on April 16 due to adverse reaction reports.

Adverse reactions that have been reported 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 has received 103 complaints worldwide of pain, internal scarring and repeat surgeries, the U.S. Food and Drug Administration (FDA) has said. Seventy-two of the reports, including three deaths, are from the United States. The FDA said that the reports alone did not establish any cause and effect for the problems, but merely suggested further inquiry.

GYNECARE INTERGEL is intended to be used in open, conservative gynecological surgery as an adjunct to good surgical technique to reduce post-surgical adhesions. Some of the reported adverse events occurred with off-label use in laparoscopy and non-conservative surgical procedures such as hysterectomy.

GYNECARE INTERGEL was approved for use in the United States on November 16, 2001. It is made by GYNECARE Worldwide, a division of Ethicon Inc., which is itself owned by Johnson & Johnson. GYNECARE's Customer Hotline is (800) 551-7683.


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