J&J To Take Gynecare Mesh off the Market
Gynecare Vaginal Mesh
Faced with more than 600 lawsuits alleging that its Gynecare pelvic mesh systems caused internal injuries, Johnson and Johnson’s Ethicon unit has announced that it would be taking four of its vaginal mesh products off the market. According to a letter to U.S. District Judge Joseph R. Goodwin, who is overseeing the litigation, Johnson and Johnson has requested approval from the FDA to stop commercializing the following devices:
- Gynecare TVT Secur System
- Gynecare Prosima Pelvic Floor Repair System
- Gynecare Prolift Pelvic Floor Repair System
- Gynecare Prolift+M Pelvic Floor Repair System
If you were implanted with a Johnson and Johnson Gynecare mesh or any other vaginal mesh implant in the treatment of POP or SUI and experienced mesh erosion or other problems, you may be entitled to compensation. Hundreds of lawsuits have already been filed and it’s not too late to make a claim - even if you are unsure as to which vaginal mesh implant you received. Fill out our free case review form today to learn more about your eligibility for compensation. There is no cost or obligation associated with this evaluation.
Ethicon Requests Time to End Sales of Mesh Systems
Ethicon requested that the FDA allow them 120 days to end the sales of these Gynecare mesh systems to inform customers of their actions and to provide medical providers the opportunity to select different treatment options for their patients. Ethicon also asked that the FDA allow them to continue selling the Gynecare Gynemesh PS with updated labeling restricting use of the product to an abdominal procedure for the treatment of pelvic organ prolapse. According to an e-mail, a company spokesman announced that Ethicon is discontinuing sales of the products worldwide, but would not recall meshes already sold or implanted.
Gynecare Prolift Sold without Proper Regulatory Approval
In March, the FDA announced that Johnson and Johnson had sold the Gynecare Prolift implant for three years without proper regulatory approval. In March 2005, Ethicon introduced the Prolift mesh as an “innovative” and “effective” surgical option for women suffering from weakened pelvic muscles. According to the FDA, it only learned of the device in 2007 when the pharmaceutical giant sought approval for a similar product. Although Johnson and Johnson claimed that it could market the Prolift without approval based on its similarity to the Gynemesh, the FDA disagreed, finding that the distribution commenced without the proper clearance. This announcement came after the agency ordered the pharmaceutical giant and 30 other vaginal mesh manufacturers to study organ damages and other side effects linked to the products.
Vaginal Mesh Lawsuits Mounting
Johnson & Johnson’s Ethicon and numerous other manufacturers have faced a mounting of number of lawsuits alleging that the meshes eroded and caused pain and injuries. If you or a loved one has experienced problems with these vaginal mesh systems, you may be able to participate in a lawsuit against the manufacturer to seek compensation for medical bills, pain and suffering and other damages. For more information, please complete our free case review form today for a no cost evaluation of your complaints.