Ethicon to Discontinue Sales of Four Vaginal Mesh Implants
Attorneys for Johnson & Johnson’s Ethicon unit informed a West Virginia Federal Judge this week that the company will stop selling four of its vaginal mesh implant products. The company currently is facing hundreds of lawsuits stemming from the implantation of these products to treat pelvic organ prolapse and stress urinary incontinence. Wexler Wallace LLP represents a number of women who have suffered injuries as a result of the mesh and is seeking damages on their behalf.
Johnson & Johnson has asked the Food and Drug Administration (“FDA”) for 120 days to end sales of Prolift, Prolift+ M, TVT Secur and Prosima vaginal mesh systems. A fifth product, Gynecare Gynemesh, may continue to be sold with changes to the labeling, provided the FDA grants Johnson & Johnson’s request. The 120 days will allow time for Johnson & Johnson to “notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients,” according to the letter sent to Judge Joseph Goodwin on June 4. In addition, during this time Ethicon will discontinue or revise as appropriate all marking materials.
The FDA first issued warnings to healthcare practitioners regarding serious complications associated with the mesh more than 3 years ago. Earlier this year, the FDA ordered Johnson & Johnson and C.R. Bard to study the rates of organ damage and infection linked to vaginal implants. In addition to Johnson & Johnson, mesh makers C.R. Bard and Endo Pharmaceutical Holdings, American Medical Systems, Boston Scientific and others have also been sued.
Wexler Wallace partner, Ed Wallace, who has litigated these cases for the past several years, said of the market withdrawal by Johnson & Johnson:
“This decision reinforces why the litigation was started in the first place. It’s unfortunate this decision was not made years ago.”
Complications associated with the mesh include pain, recurrence, infection, mesh erosion through bodily tissue, permanent nerve damage, painful sexual intercourse and other serious losses to the implantee’s quality of life. If you or a loved one has suffered complications after use of Transvaginal Surgical Mesh to treat Pelvic Organ Prolapse or Stress Urinary Incontinence, please contact us or complete our Online Form.