Complications and Risks Associated with Transvaginal Mesh
Transvaginal mesh refers to surgical mesh threaded into the vaginal area to strengthen pelvic muscles. Mesh has been used as a treatment for Stress Urinary Incontinence or Pelvic Organ Prolapse. Mesh treatment has been a favored treatment option among surgeons. In 2010, doctors inserted devices from various manufacturers in over 70,000 patients.
The results were negative for some patients who reported severe side effects. The Food and Drug Administration (FDA), which monitors the safety of medical products, issued a warning noting that in a three-year period (2005-2007) it had received more than 1,000 reports of adverse results with the device. From January 2008 through 2010, the agency said they had received 2,874 additional reports. The FDA began advising healthcare practitioners to avoid using the mesh when possible.
Common Medical Problems from Mesh
Most commonly reported problems involved erosion through the vaginal epithelium, vaginal scarring, pain (including dyspareunia), infections, urinary problems, and general ineffectiveness of the mesh. Some patients also experienced bowel, bladder, and blood-vessel perforation, or damage to other organs.
The FDA says these complications have led to a “significant decrease in patient quality of life.” Since the insertion of transvaginal mesh is permanent, the complications are often difficult to treat and additional surgeries may mitigate but not entirely correct the problems.
Claims Against Transvaginal Mesh Manufacturers
Many women and their families are already seeking compensation from the manufacturers for harm caused by transvaginal mesh. Johnson & Johnson, for example, as one of the leading makers of transvaginal mesh, faces 23,000 claims relating to the devices. Recently, the company resolved four of those cases with settlements (the details of which are confidential). Johnson & Johnson had already pulled their product from the market in 2012 following widespread publicity over complications.
Bard, a mesh manufacturer, paid $21 million to settle more than 500 lawsuits. Endo, another major manufacturer of the mesh, recently added $400 million to the $1.2 billion it had already set aside for settlements. Those additional funds were set aside over the potential for 10,000 new suits (according to Bloomberg Business) with a value of about $48,000 each.
Your Legal Options
Complications resulting from the treatment are painful, long-lasting, and can encroach on all areas of one’s life. If you or a loved one suffered as a result of a mesh product, you may be entitled to compensation. This could mean either a class-action lawsuit or an individual claim. It is crucial that you get trusted counsel in any medical malpractice case. Speak with a medical malpractice lawyer today from Gruber Law Offices, LLC in Milwaukee.
Sources:
- Bloomberg Business: Endo Said to Pay $400 Million Plus in Vaginal Mesh Accord
- J&J Agrees to First Vaginal Mesh Implant Settlements
- US Food & Drug Administration