Transvaginal Mesh Injury Lawyers in Arlington
The FDA approved the first ever transvaginal mesh product in 1996. It was called the ProteGen® sling and was introduced and manufactured by Boston Scientific. The mesh was introduced as a means to support the bladder and use was intended for treatment of stress urinary incontinence, or SUI. Unfortunately, the ProteGen® sling was recalled in 1999 after hundreds of complaints were received by the FDA. While there are currently many more manufacturers of transvaginal mesh devices, the complaints have not abated and many women have suffered injury.
Transvaginal Mesh Devices
Just like the ProteGen® sling, there were a number of transvaginal mesh devices introduced throughout the late 1990’s for treatment of the two most common conditions that occur in females: pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
- Pelvic organ prolapse (POP) – results from weak or damaged vaginal walls that allow the bladder, rectum or uterus to drop into the vaginal cavity
- Stress urinary incontinence (SUI) – results when pressure on the bladder causes complications in the ability to control urination
These conditions affect women and can result from weak or damaged vaginal walls that typically occur after pregnancy or childbirth. POP and SUI can also occur following a hysterectomy, and is a known result of menopause.
In 2008, the Food and Drug Administration (FDA) issued a public health advisory warning that serious complications could occur when transvaginal mesh devices are implanted, but reassured the public that complications were rare. Over the next three years (2008-2010) the FDA received more than 1,500 reports of complications from these devices. The FDA updated its advisory and finally admitted that complications were not rare at all and that other treatments were far safer and could be done without all of the complications that accompany transvaginal mesh implants. The FDA also ordered all of the manufacturers to conduct post-market safety studies and report back to them.
The largest makers of transvaginal mesh products include American Medical Systems, Boston Scientific, C.R. Bard, and Johnson & Johnson. Below is a list of transvaginal mesh products manufactured by these corporations.
American Medical Systems (AMS):
- Advantage™ Transvaginal Mid-Urethral Sling System
- Advantage™ Fit
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Obtryx® Transobturator Mid-Urethral Sling System
- Prefyx Mid U™ Mesh Sling System
- Prefyx PPS™ System
- Precision SpeedTac® Transvaginal Anchor System
- Precision Twist® Transvaginal Anchor System
- Uphold Vaginal Support System
- Lynx® Suprapubic Mid-Urethral Sling System
- Pinnacle® Pelvic Floor Repair Kit
- Solyx® SIS System
- Avaulta™ BioSynthetic
- Avaulta Plus™ BioSynthetic
- Avaulta Solo™ Synthetic
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
- Avaulta™ Solo Synthetic
Johnson & Johnson:
- Ethicon® TVT
- Gynecare® TVT
- Gynecare® Prosima
- Gynecare® Prolift
- Gynecare® Prolift + M
- Gynemesh PS
- Prolene™ Polypropylene Mesh Patch
If You Have You Been Injured?
If you have been injured by a transvaginal mesh device implant, the attorneys at Zinda Law Group would like to help you. Call us at (800) 863-5312 for a free no-fee consultation and let us help you today.
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