To those following the vaginal mesh controversy, Boston Scientific will always play an important role having been the company that produced Protegen, the original pelvic mesh which was used as predicate device for succeeding vaginal mesh products under the Food and Drug Administration’s (FDA) 510(k) prenotification process. It reportedly recalled the product after only two years in the market and settled more than 700 complaints from women who suffered severe complications. Boston Scientific is once again in the limelight with the huge number of vaginal mesh lawsuits filed against the company, with the first bellwether trial scheduled for early 2014 in a West Virginia multidistrict litigation (MDL).
This Massachusetts-based company was able to penetrate the urogynecological market after its Protegen fiasco with a new set of mesh products. It has been reported that these new products were made available to the market under the FDA’s 510(k) prenotification process using other mesh devices whose clearance may be traced to the recalled Protegen sling as predicate device.
Mesh products carried by Boston Scientific include the Advantage Fit Transvaginal Mid-urethral Sling Systems, Pinnacle Pelvic Floor Repair Kit, Obtryx Transobturator Mid-Urethral Sling, Lynx Suprapublic Mid-Urethral Sling System, Prefyx PPS Sling System and the Solynx SIS Vaginal Sling System.
Patients who have been implanted with these mesh products have reported serious injuries as a result of complications attributed to these devices. Among the severe complications experienced by thousands of women using these products are mesh erosion, mesh shrinkage, dyspareunia, infections, and recurrent pain. These injuries which have led to great pain and suffering have prompted these women to take legal actions against Boston Scientific.
As of October 11, 2014, there are 6,580 vaginal mesh lawsuits pending before the US District Court for the Southern District of West Virginia under Judge Joseph Goodwin. This does not include the other claims brought before various state courts in the country.
In his court order released on October 9, 2013, Judge Joseph Goodwin has set March 10, 2014 as the date of the trial for the first bellwether case involving Boston Scientific on a claim filed by Carol Lynn Fawcett. The second bellwether trial is slated to start on July 14, 2014.
Court records will show that in just nine days between October 1 to 11, 2013, 219 additional vaginal mesh lawsuits were submitted. This number is expected to increase further in the coming months as more women injured by vaginal mesh devices, such as those made by Boston Scientific, start exercising their legal rights.
References:
This Massachusetts-based company was able to penetrate the urogynecological market after its Protegen fiasco with a new set of mesh products. It has been reported that these new products were made available to the market under the FDA’s 510(k) prenotification process using other mesh devices whose clearance may be traced to the recalled Protegen sling as predicate device.
Mesh products carried by Boston Scientific include the Advantage Fit Transvaginal Mid-urethral Sling Systems, Pinnacle Pelvic Floor Repair Kit, Obtryx Transobturator Mid-Urethral Sling, Lynx Suprapublic Mid-Urethral Sling System, Prefyx PPS Sling System and the Solynx SIS Vaginal Sling System.
Patients who have been implanted with these mesh products have reported serious injuries as a result of complications attributed to these devices. Among the severe complications experienced by thousands of women using these products are mesh erosion, mesh shrinkage, dyspareunia, infections, and recurrent pain. These injuries which have led to great pain and suffering have prompted these women to take legal actions against Boston Scientific.
As of October 11, 2014, there are 6,580 vaginal mesh lawsuits pending before the US District Court for the Southern District of West Virginia under Judge Joseph Goodwin. This does not include the other claims brought before various state courts in the country.
In his court order released on October 9, 2013, Judge Joseph Goodwin has set March 10, 2014 as the date of the trial for the first bellwether case involving Boston Scientific on a claim filed by Carol Lynn Fawcett. The second bellwether trial is slated to start on July 14, 2014.
Court records will show that in just nine days between October 1 to 11, 2013, 219 additional vaginal mesh lawsuits were submitted. This number is expected to increase further in the coming months as more women injured by vaginal mesh devices, such as those made by Boston Scientific, start exercising their legal rights.
References:
- bloomberg.com/news/2011-10-20/j-j-vaginal-mesh-approved-by-fda-based-on-older-recalled-device.html
- wvsd.uscourts.gov
- bostonscientific.com