Transvaginal Mesh Injury Lawyers in Dallas
The FDA approved the first ever transvaginal mesh product in 1996 for the treatment of stress urinary incontinence, or SUI; it was later added as a corrective measure for both for pelvic organ prolapsed (POP).
- Pelvic organ prolapsed (POP) – can result from weak or damaged vaginal walls that allow the bladder, rectum or uterus to drop into the vaginal cavity; can also be caused by pregnancy and childbirth and often leads to SUI.
- Stress urinary incontinence (SUI) – occurs when pressure against the vaginal wall or the bladder causes complications in the ability to control urination, often known as overactive bladder syndrome.
These conditions occur predominantly in women and can result from weak or damaged vaginal walls that typically occur after pregnancy or childbirth. POP and SUI can also occur after a hysterectomy, and is a known condition of menopause.
Makers of Transvaginal Mesh Products
While transvaginal mesh (TVM) products are manufactured by nine different companies, six have become market leaders in the United States. These manufacturers enjoy a large share of the TVM market and market a host of different mesh products for the treatment of SUI and POP, among other things. These market leaders are:
- American Medical Systems
- Boston Scientific
- C.R. Bard
- Ethicon by Johnson & Johnson.
- Mentor Corporation
Recalls of TVM Devices
The Food and Drug Administration (FDA) issued a public health advisory in 2008 warning of serious complications that could occur when TVM devices are implanted. The FDA reassured the public that complications were rare, but after receiving more than 2,874 complaints over the next three years, the FDA updated its advisory. In the advisory, it was noted that complications from TVM devices were not rare at all and that other treatments were safer and could be done without many of the complications that accompanied transvaginal mesh implants. In addition, the FDA ordered all of the manufacturers of TVM to conduct post-market safety studies and report back to them; those reports are pending.
Meanwhile, there have been three recalls of TVM devices to date, although the first one happened more than a decade ago. Listed below are the three companies and the devices that were recalled.
- 1999 – Boston Scientific
- 2012 – C.R. Bard
- Avaulta Plus
- 2012 – Ethicon (Johnson & Johnson)
- Gynecare Prolift Kit
- Gynecare Prolift + M Kit
- Gynecare TVT Secure
- Gynecare Prosima Pelvic Floor Repair System Kit
If You Have You Been Injured?
Nearly 75,000 women had vaginal TVM devices implanted last year alone for the treatment of SUI, and more than 100,000 POP surgeries were also performed. Many of those surgeries have resulted in side effects and complications, often severe and life altering. If you have been injured by a TVM implant, you need the help of the Personal Injury attorneys at Zinda Law Group. We can help you get the care and compensation that you need and deserve. Call us today at (800) 863-5312 to speak with an attorney and let us help you. We offer a free no-fee consultation, so why not call us today?