Cutter Law P.C. Update: Transvaginal Mesh Litigation Overview

In The News:

  • Boston Scientific ordered to pay $26.7 million after losing first round in federal court over transvaginal mesh

Transvaginal mesh (TVM) is used to repair pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI) in women.

The California product liability attorneys at Cutter Law P.C. are representing women nationwide who have vaginal mesh implants and have had (or may need) revision surgery due to device failure.

To date, the most prominent manufacturers involved with TVM products include:

  • Bard
  • Coloplast
  • Cook Medical
  • American Medical Systems
  • Boston Scientific
  • Ethicon (a division of Johnson & Johnson)
  • Mentor

FDA Warnings For Transvaginal Mesh

The U.S. Food and Drug Administration had previously issued a public health notification to health care providers regarding the use of TVM, citing 1,000 reported adverse events (complications) between 2005 and 2008 from nine manufacturers.

An additional 2,784 reports had been received by December 2010, forcing the FDA to reclassify the use of TVM as high risk in an updated alert on July 13, 2011, and concede that its previous statement regarding severe injuries as "rare" was incorrect.

The updated FDA alert also recommended that physicians obtain specialized training in mesh placement techniques, be vigilant in postoperative evaluation for infection and other known signs of failure, and carefully consider the benefits of alternative, more traditional abdominal procedures. The FDA also emphasized physician disclosure of the risks and alternative surgical procedures available to patients prior to using TVM.

Complications following a transvaginal mesh implant include:

  • Additional (multiple) surgeries for repair
  • IV therapy
  • Blood transfusions
  • Drainage of abscesses caused by infection
  • Acute postoperative pain
  • Life-threatening septic infection
  • Scarring, erosion and eventual perforation of the vaginal wall
  • Organ perforation
  • Uncontrolled bleeding
  • Painful intercourse (if capable of having sexual relations at all)
  • Reoccurrence of incontinence and prolapsed organs

Once the mesh is surgically woven into the vaginal wall, full removal of the device during a repair or reconstructive surgery is very difficult.

Experience Matters

Transvaginal mesh attorney Brooks Cutter and his legal team have successfully prosecuted cases against both Boston Scientific ($240 million) and Johnson & Johnson/Ethicon (confidential settlement) for defective medical devices, representing over 5,000 clients. We understand what it takes to fight large corporations and dedicate the resources necessary to win on behalf of our clients.

Free Consultation: Contact Us Today

If you or a loved one received a transvaginal mesh implant and suffered an injury or needed further surgical repair, contact us for a free case evaluation. Give us a call toll free at 888-285-3333.