In August, a plaintiff filed a transvaginal mesh personal injury lawsuit because she received two mesh slings to treat her stress urinary incontinence (SUI), and both devices – from two different manufacturers – failed and have caused serious complications.
Plaintiffs Rita and Ronald Peschel filed their complaint on August 14th of this year, against both CR Bard, and Boston Scientific. Mrs. Peschel’s primary complaint is with the Obtryx Transobturator Mid-Urethral Sling System, manufactured by Boston Scientific, which was supposed to be a longer-lasting solution. The device was made from polypropylene, which at the time was advertised as a better solution to other transvaginal mesh materials.
However, several complaints about polypropylene, and Boston Scientific’s transvaginal mesh devices, allege that the material is not compatible with the human body. In a transvaginal mesh case brought forward by Debra Wooten, the plaintiffs cited evidence from scientific studies showing that transvaginal mesh made from monofilament polypropalyne triggers the body’s immune response to attack the device and surrounding tissue. The immune system is designed to attack foreign substances, white blood cells attack the medical device, causing the tissue in the area to become inflamed, which causes chronic pain, as well as other adverse reactions.
Rita Peschel reported in her complaint that she suffered serious side effects from the failure of her transvaginal mesh implants, but it is currently unclear what specific medical conditions developed.
The FDA has also acknowledged that polypropylene devices “may expose patients to greater risk” of medical problems, but the government agency has only recently begun investigating the complaints from transvaginal mesh patients, which have been coming in since 2001.
Rita Peschel and her attorneys allege that the FDA and other medical associations reported problems with the transvaginal mesh devices after Mrs. Peschel’s treatment. The American College of Obstetricians and Gynecologists even noted reports of problems and added that “some of these women will require surgical intervention to correct the condition, and some of the pain appears to be intractable.” However, Boston Scientific reportedly did not act on these concerns.
Mesh devices had been approved through a strange FDA law called 510(k), which allows devices that are similar to a previously-approved device to move through a fast-tracked approval process. The original mesh device, Boston Scientific’s ProteGen, received FDA approval in 1996, but was recalled in 1999 due to complaints and injury. However, in 2002, the FDA approved mesh devices for vaginal and transvaginal implantation, despite complaints against the original device.
The Strom Law Firm Accepts Transvaginal Mesh Cases
Transvaginal mesh kits were initially produced to help with pelvic organ prolapse and stress urinary incontinence. Several varieties of mesh kits exist, but transvaginal mesh specifically was supposed to produce less scarring and pain, because the procedure was less invasive. However, vaginal mesh slings can cause a host of problems, including organ perforation, infection, internal scarring, continued organ prolapsed, and bleeding. If you or a loved one has pelvic organ prolapse or stress urinary incontinence, have had a transvaginal mesh device implanted, and have since experienced detrimental complications, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC can help. We offer free consultations, so please contact us today, and we can help get you on the road to recovery. 803.252.4800.