Intergel Side Effects May Result In Infertility Lawsuits
Intergel | Lawsuits, Lawyers | Side Effects: Infertility, Severe Pelvic Pain, Repeat Surgeries, Scarring, Death
Intergel is a thick liquid gel made of sodium hyaluronate and iron. It is used during gynecological surgery to disconnect and safeguard tissues as they heal, preventing adhesions. The gel is supplied in a sterile, single-use bottle. The product was developed in a collaborative effort between Lifecore Biomedical and Gynecare, a branch of Ethicon, a Johnson & Johnson company.
The FDA originally turned down approval for Intergel in 2000, concluding that administering the gel raised a woman's risk of infection. Upon this rejection, Gynecare filed an appeal, and in November 2001, Intergel was considered convincingly safe by the FDA. Nearly a year later, the FDA's doubts were illustrated when the product was withdrawn from the market after more than 100 reports showed that the use of Gynecare Intergel led to serious health problems including reported infertility, severe pelvic pain, repeat surgeries, scarring, and death. On March 27, 2003, Lifecore withdrew Intergel from the market and suspended global sales to assess information obtained from post marketing experience with the product.
The Food & Drug Administration (FDA) has received roughly 72 reports of adverse events, including three deaths and 48 injuries, in the United States of patients who where treated with Intergel. The gel had also been used off label for uses including laparoscopic surgery, hysterectomy, and certain intestine-related procedures. Some of these uses had been warned against.
Former Chief Medical Examiner Blows Whsitle On Johnson & Johnson
Dr. Joel Lippman claims that during his 15 years in high-ranking medical positions at Johnson & Johnson subsidiaries, Elthicon Inc. and Ortho McNeil, Johnson & Johnson constantly released or refused to recall dangerous products to which he objected. One of the products was Intergel, which caused frequent product liability lawsuits displaying that Intergel spreads infection during surgery, rather than preventing it. In 2002, Dr. Lippman, said that he “insisted on the recall of Intergel, which had caused serious injuries and was related to a number of deaths.
Lippman says that he demanded for more than a year that Intergel be recalled, and that after a decision to recall the product was made, he was summoned to the office of the Chairman of Medical Devices & Diagnostics for J & J in New York City, where the Chairman and four attorneys attacked him for the decision to recall Intergel.
Legal Rights for Intergel Users
If you or a loved used Intergel and suffered side effects, please fill out the short form to the right for a free case evaluation by a qualified defective drugs attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).