Life-changing injuries caused by a defective transvaginal mesh surgical device. An Arizona woman has become the latest to claim that she’s suffered serious and life-changing injuries caused by a defective transvaginal mesh surgical device.
In a lawsuit filed recently in U.S. District Court for the Southern District of West Virginia, the Arizona woman claims she received a defective Obtryx Transobturator Mid-Urethral Sling System manufactured by Boston Scientific Corp. Her lawsuit has been filed alongside numerous others which make similar claims against the device in a federal Multidistrict Litigation known as In Re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation (MDL No. 2326).
In this latest claim, the Arizona woman received the Obtryx Transobturator Mid-Urethral Sling System in a February 2006 procedure. This device, along with other transvaginal mesh products, was approved to treat conditions common among many women, stress urinary incontinence and pelvic organ prolapse. The risk of developing these conditions, caused by weaknesses or failures of the pelvic wall, increases after a woman endures childbirth.
Transvaginal mesh devices were mostly approved for use through the Food and Drug Administration’s maligned 510(k) “fast-track” approval system that grants clearance to the open market without the benefit of having endured much pre-market safety testing.
Arizona woman says she began developing complications common among victims
After receiving this Boston Scientific device, the Arizona woman says she began developing complications common among victims of a defective transvaginal mesh device. These include erosion of the mesh through the vagina, severe pain, infections, bleeding, pain during intercourse, organ perforation, and other urinary problems.
Furthermore, the lawsuit claims that because the materials used in the Obtryx Transobturator Mid-Urethral Sling System are not inert, and that leads to many of these complications.
The woman also claims that Boston Scientific was aware of the potential problems its transvaginal mesh device could cause but continued to market it as a safe and effective treatment for these conditions.
This lawsuit and many others have been filed in the last two years after the FDA warned in the summer of 2011 that injuries caused by transvaginal mesh devices were “not rare” and the agency has ordered makers of these devices, like the Obtryx Transobturator Mid-Urethral Sling System, to produce post-market safety data that shows the devices to be safe and effective than traditional means of treating these conditions.