The Food and Drug Administration (FDA) approved Intergel in November 2001 as an anti-adhesion surgical gel for gynecological surgeries. The product, Gynecare Intergel Adhesion Prevention Solution, is manufactured by Lifecore Biomedical, Inc. of Minnesota and before its April 2003 recall was used to help reduce post-operative internal scarring that led to intestinal obstruction and chronic pain.
The FDA originally refused to approve the product, concluding that administering the gel increased a woman's risk of infection
. Lifecore appealed the denial and the FDA allowed a panel of scientists to reevaluate the agency's decision. The appeal commission reversed the FDA's initial denial and approved the adhesive.
Throughout Intergel's short history, the FDA considered the product only "reasonably safe." According to the agency, 5.6% of those who received the gel developed an infection at the surgical site compared to only 2.9% of women who received more conventional treatment.In April 2003, GYNECARE Worldwide (a Johnson & Johnson Company) and the FDA Center for Devices
and Radiological Health (CDRH) announced the voluntary market withdrawal of
"GYNECARE INTERGEL Adhesion Prevention Solution" from the global market, urging customers to immediately stop using this device. 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.
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.
See your doctor if you have experienced serious health problems because of Intergel. In addition, it may be important to contact an attorney
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.
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