Transvaginal Mesh Product Dangers
Having had enough with the women in his state’s suffering, Kentucky’s attorney general- Andy Beshear- is suing Johnson & Johnson for millions of dollars. He says the company has “concealed and misrepresented” the risk of its transvaginal mesh products to doctors and patients. The lawsuit lists chronic pelvic pain, pain associated with intercourse and/or the loss sexual function, as well as other health problems.
Johnson & Johnson have called the lawsuit “unjustified”.
AG Beshear says that more than 15,000 women in Kentucky have had transvaginal mesh implanted but that Johnson & Johnson, via its medical device company, Ethicon, didn’t provide enough information about adverse effects to the patients.
From the article:
“The way this company clearly chose profits over people is outrageous,” Beshear said in a written statement. “My office has talked to victims whose lives have been devastated by this company’s deceitful practices. We may not be able to give them back the lives they once had, but my office will do everything we can to hold this company accountable.”
The lawsuit says one of the misrepresentations the company made was that it said its products were approved by the Food and Drug Administration. It adds the surgical mesh devices were FDA cleared, not approved.”
Johnson & Johnson, however, denied they were deceitful, maybe because transvaginal mesh is good business: they sold $6.4 billion worth of medical devices worldwide in the second quarter of 2016.
And so with this suit, Kentucky becomes the third state, behind California and Washington, to sue Johnson & Johnson over the marketing of transvaginal mesh products. While the FDA cleared mesh devices in 2002, they did so marking them as a “moderate-risk device”. Then, this past January, the FDA reclassified the devices into the “high-risk” category and gave companies 30 months to submit applications for premarket approval. If that information wasn’t being communicated to thousands of women, they need to pay the consequences.