In 1996, the FDA approved the first transvaginal mesh device manufactured by Boston Scientific. The first Boston Scientific vaginal sling, called Protegen, was designed to treat stress urinary incontinence in women, and set a precedent that would enable a slew of other transvaginal mesh devices to be receive FDA clearance for marketing and sale in the U.S. Since its first product, Boston Scientific developed several other pelvic mesh or bladder sling products including:
- Advantage Fit Transvaginal Mid-Urethral Sing System
- Lynx Suprapublic Mid-Urethral Sling System
- Obtryx Transobturator Mid-Urethral Sling
- Pinnacle Pelvic Floor Repair Kit
- Prefyx PPS Pelvic Sling System
- Solynx SIS Vaginal Sling System
- Solynx SIS Vaginal Sling System
What is a Transvaginal Mesh Device?
Transvaginal surgical mesh devices are used to treat two conditions: pelvic organ prolapse and stress urinary incontinence, both of which are caused by weakening of the muscles surrounding the affected organs. Traditional surgeries used to treat either condition used sutures to lift the sagging organ and did not use any implants. Although the use of a surgical mesh in urogynecological surgeries became popularized by doctors who believed the mesh provided additional support, the FDA recently released a statement concluding that there was no evidence to substantiate those claims, but that the transvaginal mesh devices increased the risk of complication in patients.
FDA 510(k) Clearance Process
FDA 510 (k) clearances are an expedited approval process that does not require the same rigorous clinical testing and review required of premarket approvals products. The first transvaginal mesh product manufactured by Boston Scientific was approved with little more than a three-month rat study as evidence of its safety and efficacy. Within a couple years, other medical device manufacturing companies such as Johnson & Johnson, American Medical Systems, and C.R. Bard received clearance for their respective transvaginal mesh implants via the FDA 510(k) process. An investigation of the medical literature pertaining to transvaginal mesh slings revealed that there was little if any evidence supporting the use of mesh implants in urogynecological surgeries.
Boston Scientific Legal Issues
Presently, Boston Scientific is one of several medical device-manufacturing companies facing product liability litigation related to transvaginal mesh products. However, this is not the first time Boston Scientific faced lawsuits over its vaginal devices, in 2003 the company settled 738 lawsuits filed by women who suffered severe complications from the then-recalled Protegen device. By 2010, the FDA estimated 300,000 women received transvaginal mesh implants, and had received more than 4,000 reports of adverse events such as:
- Pelvic pain or pain during sex
- Organ perforation
- Urinary problems
- Vaginal bleeding
- Neuro-muscular problems
- Vaginal scarring/shrinkage
Seek Legal Representation
The Boston Scientific vaginal mesh implant lawyers at Estey Bomberger are screening potential product liability claims for women who have experienced complications or serious side effects following a transvaginal surgery. If you have received a mesh implant during a pelvic organ prolapse repair surgery or a vaginal sling to treat stress urinary incontinence, please contact our experienced defective medical device attorneys for a free consultation.