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GYNECARE INTERGEL Adhesion Prevention Solution Recall — Class Action Lawsuit?

GYNECARE Worldwide, a division of Ethicon Inc. of Somerville, New Jersey, notified the FDA in June 2003 that they were withdrawing “GYNECARE INTERGEL Adhesion Prevention Solution” from the market and were urging customers to immediately stop using the device.

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 conducted this 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 indicative of other serious complications, and physicians should be aware of this in managing patients in the post-operative period.

Intergel is manufactured by Lifecore Biomedical, Inc., and is marketed by Johnson & Johnson’s Gynecare unit. Intergel is used to reduce internal scarring from gynecological surgery. Intergel gained FDA approval in 1998.

Click here to see the letter that Gynecare sent out to doctors on March 28, 2003.

To this date, the FDA has received 72 reports of adverse events, including three deaths and 48 injuries to patients in the United States who where treated with Lifecore’s Intergel.

If you or someone you know has been harmed by Gynecare Intergel, please contact Audet & Partners immediately to protect your rights.

Persons seeking to preserve any potential legal claims should contact an attorney promptly, since all states have mandatory time periods in which lawsuits must be filed with the courts; otherwise, they may be forever barred. Audet & Partners represents individuals, governmental entities, small businesses and institutional shareholders in product liability, tort, negligence, consumer, construction defect, investment fraud, securities, insider trading, antitrust, environmental, whistle blower, aviation and employment cases. In recognition of their outstanding abilities and commitment to the legal profession over the years, the firm and its members have served as Court-appointed Plaintiffs’ Counsel in dozens of federal and state cases throughout the United States.