Boston Scientific Transvaginal Mesh Lawsuit
Boston Scientific faces transvaginal mesh lawsuits alleging the company's transvaginal mesh device was defectively designed and improperly tested. Among the alleged transvaginal mesh complications are a risk of mesh erosion, infection and pelvic pain. Thousands of lawsuits have been filed against Boston Scientific and the makers of other transvaginal mesh products, alleging women were harmed by the use of these devices.
Transvaginal Mesh Devices
The US Food and Drug Administration (FDA) has released repeated warnings about transvaginal mesh devices, although as of January 2015 the devices have not been recalled. In 2011 the FDA warned that the use of surgical mesh to treat pelvic organ prolapse may have greater risk than other surgeries without evidence of greater benefit.
In 2014, the FDA proposed a reclassification of surgical mesh devices used for pelvic organ prolapse from being a moderate-risk device to a high-risk device. That move requires manufacturers to submit a premarket approval application for the devices. The FDA's announcement came after a September 2011 advisory panel recommendation that the devices be reclassified.
Transvaginal sling complications include the following:
- mesh erosion into the vagina, bladder, intestines and uterus
- pelvic pain
- urinary problems, including recurrence of prolapse and/or incontinence
- development of urinary retention
- bowel, bladder, and blood vessel perforation during insertion
- vaginal scarring
- dyspareunia (pain with sexual relations)
- fistulas and recurrence of prolapsed organs
- neuropathic pain
Boston Scientific Transvaginal Mesh Devices
- Advantage Transvaginal Mid-Urethral Sling System
- Obtryx® Transobturator Mid-Urethral Sling System
- Pinnacle® Anterior-Apical Pelvic Floor Repair Kit
- Pinnacle® Duet Pelvic Floor Repair Kit
- Pinnacle® Posterior Pelvic Floor Repair Kit
- Uphold Vaginal Support System
Boston Scientific Lawsuits
- An award for $18.5 million to four women in November 2014;
- An award for $26.7 million to four women in November 2014;
- An award for $73 million to a woman in September 2014 (later reduced to $34 million).
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