Gynecare Prolift Transvaginal Mesh Named in LawsuitOct 11, 2011 | Parker Waichman LLP
Johnson & Johnson continues to be named in lawsuits alleging its Gynecare Prolift transvaginal mesh left women with permanent and painful injuries. The most recent lawsuit was filed by Linda Gross, 46, of Watertown, South Dakota, who received Gynecare Prolift transvaginal mesh in 2006 to repair pelvic organ prolapse (POP).
Since her initial surgery, gross say she has suffered urinary complications and constant pain due to her body's rejection of the Gynecare Prolift device. According to her complaint, Gross has undergone 12 additional surgeries, but has had no relief. Today, Gross says she cannot sit for longer than 20 minutes, cannot have sex with her husband, and she can’t be active for more than a few minutes at a time.
In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.
Last month, FDA staff proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances. Under the FDA proposal, transvaginal mesh devices already on the market would be allowed to remain, but manufacturers would have to conduct studies to asses their safety and effectiveness. An FDA panel of outside experts has backed both proposals.
Attorneys report that they are receiving an "amazing number of calls" from women who allegedly suffered transvaginal mesh complications following surgery to repair POP. As we've reported previously, about 300,000 women in the U.S. had POP surgeries last year, including more than 70,000 who received transvaginal mesh.