Gynecare Prolift Transvaginal Mesh Problems
Recently it has come to light that Johnson & Johnson’s Ethicon subsidiary introduced and sold their Gynecare Prolift transvaginal mesh several years before obtaining FDA approval to market the device. The lawyers at Saiontz & Kirk, P.A. represent women throughout the United States who have experienced problems with Ethicon’s Gynecare Prolift mesh, which has now been linked to devastating and painful injuries.
The FDA’s fast-track medical device approval process, known as 510(k), has received substantial criticism in recent years for being too quick and allowing dangerous products to reach consumers without being rigorously tested. However, for Johnson & Johnson, the process was apparently not fast enough.
According to an article last week by Bloomberg News, the medical giant’s Ethicon division began selling the Gynecare Prolift transvaginal mesh in 2005, but the FDA did not approve the device until 2008.
Although Johnson & Johnson has indicated that it thought it was allowed to sell the device because the Gynecare Prolift mesh was substantially similar to Ethicon’s Gynecare Gynemesh, the FDA has indicated that they disagree with this position and did not even learn that the Prolift was on the market until 2007, when the manufacturer asked for approval of a related device.
Between 2005 and 2008, approximately 123 adverse event reports involving Ethicon Gynecare Prolift mesh problems were submitted to the FDA, according to Bloomberg.
The Gynecare Prolift transvaginal mesh is one of a number of different products made by several manufacturers that have been associated with a risk of problems like:
- Erosion of the mesh through the vagina
- Infection
- Pelvic Pain
- Hardening or Shrinkage of the mesh
- Pain during sexual intercourse
- Urinary problems
- Injury to nearby organs
The products, which are also commonly referred to as a vaginal mesh or bladder slings, are implanted to support the bladder or other organs and treat pelvic organ prolapse (POP) or female stress urinary incontinence. However, concerns have grown in recent years about the risks associated with transvaginal mesh, and evidence suggests that they may provide no benefits over other treatment options.
ETHICON GYNECARE PROLIFT MESH LAWSUIT
Johnson & Johnson has acted with apparent disregard for the safety of consumers in manufacturing and promoting the Ethicon Gynecare Prolift mesh. The fact that they introduced the product without obtaining FDA approval provides further support for claims brought by women throughout the United States.
The transvaginal mesh lawyers at Saiontz & Kirk, P.A. are reviewing potential claims for women throughout the United States. In addition to lawsuits over the Ethicon Gynecare Prolift mesh, claims are also being reviewed for women who received other types of surgical mesh that was transvaginally placed to repair pelvic organ prolapse or female stress urinary incontinence. Some other common products used during these procedures include:
- Bard Avaulta Support System
- AMS Elevate Prolapse Repair System
- AMS Apogee Vault Suspension System
- AMS Perigee System
- AMS Monarc Sling System
- AMS Sparc Sling System
- Ethicon Gynecare Gynemesh
- Ethicon Gynecare Prolene Soft Mesh
- Ethicon Gynecare TVT Transvaginal Sling
- Boston Scientific Pinnacle Pelvic Floor Repair Kit
- Boston Scientific Uphold Vaginal Support System
- UGYTEX Dual Knit Mesh
- Coviden IVS Tunneler Sling
No Comments • Add Your Comments