Gynecare Intergel Linked To Pain, Tissue Adherence, and Internal Scarring

Chaska, MNLawyers are investigating the possibility of filing lawsuits against Ethicon Inc., after a number of women were harmed by the use of Gynecare Intergel Adhesion Prevention Solution. The solution was used during gynecological surgery to protect tissue as it healed but in some cases it caused serious injury to patients.

The United States Food and Drug Administration (FDA) received 103 complaints of injury, including three deaths, associated with Gynecare. Other injuries included pelvic pain, internal scarring, infertility, allergic reactions, and tissue adherence. Some of the women who suffered injury from Gynecare required additional surgery to correct the problems.

On March 28, 2003, Gynecare Worldwide sent a letter to physicians titled "Urgent Voluntary Market Withdrawal of Gynecare Intergel Adhesion Prevention Solution." The letter advised doctors to immediately discontinue use of the product while Gynecare assessed information it had received regarding reports of "onset of pain, non-infectious foreign body reactions, and tissue adherence."

According to a United States Securities and Exchange Commission (SEC) filing, Lifecore Biomedical Inc. was a defendant in 80 product liability lawsuits in which the plaintiffs claimed they suffered injury after Gynecare Intergel was used in their surgery. Other defendants in the suits included Ethicon, Inc., Johnson & Johnson, and Vital Pharma, the contract packager for Intergel Solution. The filing states that as of September 20, 2006, settlement documents for 79 of the lawsuits were executed. However, settlement of those suits does not mean other lawsuits cannot be filed.

In 2004, Lifecore received a letter from the FDA Center for Devices and Radiological Health (CDRH) warning that Gynecare Intergel was misbranded and the company did not submit required Medical Device Reports (MDRs) for 11 complaints that involved device malfunctions related to serious injury or death. The FDA's warning letter stated "Specifically, for 11 separate events...you failed to submit an MDR to the Food and Drug Administration (FDA) within 30 days of receiving information that reasonably suggested that one of your commercially distributed devices may have caused or contributed to a death or serious injury." The letter went on to cite the case of a patient who developed severe abdominal pain with tachydardia, high temperature, and shortness of breath. An examination of the patient showed that the left side of her pelvis appeared frozen which is a sign of serious adhesive disease.

Gynecare Intergel was approved for use in the market in 1998 and voluntarily withdrawn in 2003. It was approved by the FDA for use in open gynecologic procedures but was also used off-label for laparoscopic surgery and hysterectomies. The solution was not approved for laparoscopic surgery because studies showed a higher infection rate associated with its use. Gynecare Intergel was not shown to be either safe or effective in laparoscopy or in hysterectomy.

Gynecare Intergel was used in surgery to prevent adhesions. Adhesions occur in the majority of women who have abdominal surgery, including removal of fibroid tumors and treatment of endometriosis, and can cause infertility and bowel obstruction. Intergel, a solution made of sodium hyaluronate and iron, was developed to prevent adhesions by separating and protecting tissues after the surgery.

Gynecare is a division of Johnson & Johnson. Lifecore Biomedical Inc manufactured the Intergel Solution.