Dangerous Drugs - Intergel
Intergel is used during gynecological surgery to safeguard and disconnect tissues as they heal, preventing the tissue from adhering to foreign surfaces. The thick liquid gel is supplied in a sterile, single-use bottle. It was developed in a collaborative effort between Lifecore Biomedical and Gynecare, a branch of Ethicon, a Johnson Johnson company.
In the year 2000, the FDA rejected approval of Integral after concluding the drug elevated a woman's risk for infection. After the rejection, Gynecare filed a successful appeal and the drug was approved in 2001.
The FDA had reason for its doubts concerning the drug. In March of 2003, the creator of the drug, Lifecore, withdrew the drug from the market, citing an assortment of symptoms including:
- Repeated Surgeries
- Reported Infertility
- Severe Pelvic Pain
- Death
- Scarring
Since its withdrawal, the FDA has released approximately 72 reports of adverse events related to Intergel, including three deaths. In addition to gynelogical surgery, the gel is also used for laparoscopic surgery, hysterectomy, and intestine-related procedures.
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