Johnson & Johnson’s Ethicon, Inc. division stated on June 4,2012 that they would stop selling 4 of their transvaginal mesh implants: Gynecare TVT Secur system, the Gynecare Prolift, the Gynecare Prolift+, and the Gynecare Proisma.
Ethicon and Johnson & Johnson had been named in a couple hundred transvaginal mesh implant injury lawsuits, and asked the FDA for their approval to stop selling the devices through a letter filed with the US District Court, Southern District of West Virginia. The company will stop sales of these implants throughout the next 3-9 months, their goal is to end sales world-wide in the beginning of 2013.
Currently, there have been many women have been experiencing problems following a pelvic organ prolapse repair surgery or a stress urinary incontinence using a Ethicon Gynecare mesh, or other bladder sling products.
The Gynecare surgical mesh is designed to support prolapsed organs and improve symptoms that are associated with both SUI and POP by acting as a hammock. They are surgically implanted during a pelvic organ prolapse (POP) to help in providing support for a woman’s pelvic organs when they fall, drop or prolapse into the vaginal wall because of weakened muscles.
Ethicon Gynecare Mesh side effects include:
- Hardening of the mesh
- Urinary problems
- Mesh erosion
- Injury to organs nearby
- Pelvic pain
- Difficulty during sex
The FDA has recently had thousands of reports of adverse affects when using the Ethicon Gynecare vaginal mesh system and vaginal mesh products made by other companies. These devices have a high risk of developing serious complications and there is not any evidence to prove that the insertion of a bladder sling will provide any benefit over another type of treatment available for pelvic organ prolapse.
These devices were first approved by the FDA under their 510(k) Premarket Notification System, and allows a manufacturer to begin selling their product without extreme premarket testing when a product is supposed to be equivalent to another already approved product.
If you have been experiencing side effects after a POP using the Ethicon Gynecare transvaginal mesh, you may have a legal case. Since the company failed to put their patients safety ahead of profits, there have been thousands of women who became exposed to painful injuries that might permanently affect their life. Get the legal help you need today, you may be eligible to claim compensation for any pain, suffering, or medical expenses the Ethicon Gynecare transvaginal mesh may have caused you.