Mounting research and numerous case studies have determined that Ethicon Gynecare Mesh has been associated with a much higher rate of adverse health complications than rival transvaginal mesh products. In June 2012, Ethicon (a Johnson & Johnson company) decided to discontinue its line of Gynecare Mesh devices and pull them off the market. The company reportedly made the decision after being hit with more than 1,000 lawsuits over it surgical mesh products.
Free Gynecare Mesh Recall Lawsuit Evaluation: If you or a loved one has been injured or suspect that you may have complications directly linked to the placement of a Gynecare Mesh product, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Which Gynecare Mesh Devices Have Been Recalled?
It is important to note that while an official Gynecare Mesh recall has not been enforced, Ethicon decided to discontinue the following devices after they were linked to a large number of adverse health complications:
- Gynecare Prolift Kit
- Gynecare Prolift + M Kit
- Gynecare TVT Secure
- Gynecare Prosima Pelvic Floor Repair System Kit
These products, which are used for the repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI), have been associated with a number of serious complications including:
- erosion of vaginal tissue
- mesh erosion
- perforations of the bowel, bladder or blood vessels
- recurrence of pelvic organ prolapse (POP) and stress urinary incontinence (SUI)
- urinary problems
- vaginal scarring
Although not technically considered a recall, the action by Ethicon essentially constitutes a nationwide recall for Gynecare mesh products. In announcing the action, Ethicon requested that the U.S. Food & Drug Administration (FDA) allow it four months to “cease commercialization,” so that they could provide healthcare facilities with enough time to select alternative treatment options, revise marketing materials, and notify customers of the change.
Ethicon also petitioned the FDA to place a hold on recent orders so that they could conduct additional research to assess the risk of transvaginal mesh products. The administration required all manufacturers of such devices to perform these studies after thousands of women experienced complications after procedures to repair POP and SUI. The FDA ordered the additional testing to give the agency a better understanding about whether the health risks associated with vaginal mesh products outweigh the potential benefits.
Do I Have a Gynecare Mesh Recall Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Gynecare Mesh recall lawsuits. We are handling individual litigation nationwide and currently accepting new Gynecare Mesh recall lawsuits in all 50 states.
Free Gynecare Mesh Recall Lawsuit Evaluation: Again, If you or a loved one has been injured or suspect that you may have complications directly linked to POP or SUI surgery and/or the placement of a Gynecare Mesh product, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.