J&J Failed to Warn about Risks of Prolift Transvaginal Mesh, Jury Rules


J&J Failed to Warn about Risks of Prolift Transvaginal Mesh, Jury RulesOverview: Jurors have awarded a verdict of $3.35 million to Plaintiff Linda Gross in the first of 2,100 lawsuits to go to trial over the Gynecare Prolift transvaginal mesh. Gross sued Ethicon and Johnson & Johnson over the Prolift, which allegedly caused serious injuries due to its defective design. According to Bloomberg, the jury ruled the Johnson & Johnson failed to warn about the risks of the Prolift, a device that the company is currently under investigation for.

  • Plaintiff Linda Gross has been awarded $3.35 million in the first Gynecare Prolift trial
  • The jury ruled that J&J failed to warn about the risks of the transvaginal mesh
  • There are 2,100 lawsuits alleging that the Prolift caused serious injuries in women; the company is currently being investigated by the government over the way it marketed the device

Product: Prolift, Prolift + M, TVT Secur, and Prosima transvaginal mesh implants

Manufacturer: Ethicon, Inc./Johnson & Johnson

Side Effects & Complications

  • Mesh erosion
  • Pain during sexual intercourse (dyspareunia)
  • Perforation or puncture of the bladder, bowels, intestines, and blood vessels near the vaginal wall
  • Recurring Pelvic Organ Prolapse (POP)
  • Vaginal bleeding
  • Urinary problems
  • Chronic vaginal drainage, discharge, or infection
  • Vaginal scarring and shortening

Jury Rules in Favor of Transvaginal Mesh User

On the fifth day of deliberations in the case of Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey, jurors ruled that Johnson & Johnson’s Ethicon unit failed to properly warn about the risks of the Prolift transvaginal mesh. The company has been ordered to $3.35 million to Linda Gross, a 47-year old nurse from South Dakota who underwent 18 operations after receiving the mesh. Gross had testified before jurors that her life worsened dramatically after receiving the mesh. . “Who you see standing here now is not who I was,” she said. “I was eager and energetic, loved to go to work, loved to participate in church activities, school activities.” She has been through at least 400 doctors visits for her condition and has described the experience as “horrific”. “I am fearful of dying because this pain is so bad,” Gross stated.

Gynecare Prolift and Transvaginal Mesh Safety Issues

Last year, Johnson & Johnson said they would no longer be selling four types of transvaginal mesh, including the Prolift. The device came under scrutiny when it was reported that J&J had sold the mesh with obtaining proper approval from the U.S. Food and Drug Administration (FDA). We recently reported that Johnson & Johnson is under investigation by the government over the way it marketed the Prolift. The Gynecare Prolift and other transvaginal mesh implants are used to treat pelvic organ prolapse and stress urinary incontinence. Lawsuits filed over the device, however, allege that it does more harm than good. The FDA has warned that complications from transvaginal mesh devices are “not rare”; in the fact, the agency said that there is little evidence that these devices offer any benefits over non-mesh methods of treating pelvic organ prolapse.