Drug Injury
Gynecare Intergel™
Gynecare Intergel™ withdrawn from the market!
In 2001, the makers of Gynecare Intergel™, the first liquid scar-prevention surgical solution to be used in open pelvic surgery, encountered many problems in their quest for FDA approval. The FDA initially rejected the product, citing unacceptable risks. But when the Intergel makers resorted to an unprecedented appeal, the FDA reluctantly approved the risky product in November 2001. Barely a year later, the FDA’s reservations proved valid when the product was withdrawn from the market after over 100 reports showed that the use of Gynecare Intergel led to serious health problems including severe pelvic pain, scarring, repeat surgeries, reported infertility and even death.
What is Gynecare Intergel?
Gynecare Intergel Adhesion Prevention Solution is a liquid scar-preventing treatment that was approved for use during open gynecologic surgeries. The solution works by lubricating the surfaces of the abdominal lining to separate and protect organs and tissues as they heal, thereby creating an environment that is less conducive to the formation of post-operative scars. Internal scar tissue can cause chronic pain, intestinal obstruction, infertility and other debilitating problems.
Gynecare Intergel was deemed “reasonably safe” and approved by the FDA in November 2001 after the prolonged and dramatic rejection-appeal-approval process. The product was developed in a collaborative effort between Lifecore Biomedical and Gynecare, a division of Ethicon, a Johnson & Johnson company.
What are the side effects?
Soon after Gynecare Intergel was approved for use, some women began reporting post-operative complications believed to be caused by the surgical solution, including:
- Pelvic pain
- Allergic reactions
- Scarring, and related complications
- Infertility
- Repeat surgeries
One disturbing note, and perhaps a factor in the complications experienced with Gynecare Intergel use: in some follow-up surgeries, it was reported that hardened Intergel residue still remained inside the body. The surgical solution was only supposed to remain inside the body for 7 days, to facilitate the healing process, after which it would be naturally—and completely—flushed out of the body.
Who is at risk?
At least 80,000 doses of Gynecare Intergel were sold in the U.S. and 22 other countries. The surgical solution was approved for use in “open, conservative gynecologic surgery,” a term which encompasses several fairly common surgical procedures to treat female health problems such as:
- Ovarian cysts
- Fibroids
- Endometriosis
- Laparoscopic surgery
- Hysterectomy
- Certain intestine-related procedures
Because Gynecare Intergel was found to only marginally decrease the occurrence of scars and almost doubled the risk for infection, the FDA initially rejected the application for approval. It was only through the never-before-used appeals process that the FDA was forced to take a second look at the Intergel studies. After examination of the product by a panel of independent scientists, the FDA rendered its approval at their suggestion, albeit with reservations. Upon hearing news of Gynecare Intergel’s official approval in November 2001, Lifecore’s president was reported as stating, “We don’t care how it got approved, we just care that it got approved.”
In March 2003, barely a year after the surgical gel’s marketing debut, sales of Intergel were halted after the FDA announced over 100 reports of pain, internal scarring, repeat surgeries and 3 deaths. Sales have not since resumed.
What if Gynecare Intergel was used during my surgery?
If Gynecare Intergel was used during your surgery and you have yet to experience any problems, be conscious of any questionable symptoms, and contact your physician immediately if you begin to experience pelvic pain, as this may be a sign of more serious health complications. Contact our lawyers today for an immediate and confidential evaluation of your case.
This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice you should always consult with your physician.
Intergel™ is a trademark of Ethicon, Inc., one of the Johnson & Johnson group of companies, and is used here only for the purpose of identifying the product in question.
This law firm is not affiliated with, sponsored by or associated with the FDA, Gynecare, Ethicon, Inc., Lifecore Biomedical, or Johnson & Johnson companies.
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