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Boston Scientific Wins First Transvaginal Mesh Trial

First Bellwether Trial Against Boston Scientific Goes to Transvaginal Mesh Manufacturer

transvaginal meshBoston Scientific has won their first bellwether trial involving their transvaginal mesh devices when a Massachusetts jury rejected the plaintiff’s claims of faulty design.

On Tuesday, July 29th, jurors found that Boston Scientific’s Pinnacle transvaginal mesh device was properly designed and implanted, and that the manufacturer adequately warned plaintiff Diane Albright and her doctors about the potential dangers of using such a device.

The bellwether trial is one of more than 12,000 personal injury lawsuits in a multidistrict litigation (MDL) against the transvaginal mesh manufacturer, alleging that the device causes serious, long-term damage to the body.

“We are pleased with the outcome,” Denise Kaigler, a spokeswoman for Boston Scientific, said in an e-mail. “Patient safety is of utmost importance to Boston Scientific and we dedicate significant resources to deliver safe, high-quality products.”

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 next transvaginal mesh trial in Massachusetts is set for August 11th, and the next bellwether trial is set for November of this year.

History of Transvaginal Mesh Problems

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.

The six current transvaginal mesh MDLs are:

  1. C.R. Bard MDL 2187: In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation.
  2. Johnson & Johnson/Ethicon MDL 2327: In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation
  3. American Medical Systems MDL 2325: In Re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation
  4. Boston Scientific MDL 2326: In Re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation
  5. Mentor ObTape MDL 2004: In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation
  6. Coloplast MDL 2387: IN RE: Coloplast orp. Pelvic Support Systems

Recently, due to the high number of personal injury claims involving transvaginal mesh devices, CR Bard, Endo Health Solutions, Boston Scientific, Coloplast, and Cook Medical, began settlement talks. Reportedly, these five transvaginal mesh manufacturers faced a total of 30,000 personal injury lawsuits. Johnson & Johnson, meanwhile, has not agreed to any settlement talks and will continue facing bellwether trials in its MDL in Virginia.

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, vaginal mesh slings can cause a host of problems, 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



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