Boston Scientific Found Liable for Transvaginal Mesh Injury in Dallas Trial
Boston Scientific has lost a personal injury trial in Dallas, which alleges that the company failed to warn about the potential side effects of its transvaginal mesh devices and was negligent toward patients and doctors.
Martha Salazar’s personal injury case was separate from the 12,000 transvaginal mesh injury cases in a multidistrict litigation (MDL). The plaintiff was a property manager in Dallas, but after receiving a transvaginal mesh implant, which she received to treat her urinary incontinence, Salazar suffered severe pain and infection. She sought to have the transvaginal mesh removed, but surgeons were unable to take it out. Consequently, she was unable to continue working.
The jury reportedly returned on the same day of deliberations, deciding in favor of the plaintiff. The judge awarded her $23 million in compensatory damages for physical and mental anguish, and $50 million in punitive damages against Boston Scientific.
Meanwhile, Boston Scientific also faces its second bellwether case in its MDL, which began on August 14th. Plaintiff Maria Cardenas alleges similar damages as Salazar, including chronic pain, infection, bleeding, and continued urinary incontinence.
Boston Scientific won its first transvaginal mesh bellwether case on July 29th of this year. Other transvaginal mesh manufacturers, such as CR Bard and Johnson & Johnson’s Ethicon unit, have faces several bellwether trials in their MDLs.
Transvaginal mesh was originally developed in 1996 and approved by the FDA for organ prolapse that caused vaginal pain and stress urinary incontinence. The original transvaginal mesh, Boston Scientific’s ProtoGen, was recalled in 1999, but due to an FDA approval loophole called 510(k) – which fast-tracks approval of devices similar to previously-approved devices – many other medical manufacturing companies began developing transvaginal mesh devices of their own.
Because of numerous complaints about the transvaginal mesh devices eroding, which can cause organ perforation, bleeding, infection, severe pain, and continued organ prolapse, the FDA ordered major transvaginal mesh manufacturers like Boston Scientific and Johnson & Johnson to study the devices’ effectiveness more in depth. Recently, the regulatory agency stated that it would not allow any more transvaginal mesh devices to use the 510(k) process, which allows medical devices substantially similar to previously-approved devices to get a “quick approval.” Transvaginal mesh devices today are based on one original device, the Gynecare ProLift, which was approved in 1996 but then recalled in 1999 because of the side effects.
The Strom Law Firm Fights for Women in Transvaginal Mesh Personal Injury Case
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, Transvaginal Mesh Injury can arise from vaginal mesh slings, including organ perforation, infection, internal scarring, continued organ prolapse, 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