Product Liability

Women should discuss with doctors safety of transvaginal mesh

As the Food and Drug Administration (FDA) gears up to determine the fate of surgical mesh used to treat pelvic floor disorders, women who suffer from these conditions are left asking what options they have for treatment.

Surgical mesh is a device used to repair various conditions including stress urinary incontinence (SUI) and pelvic organ prolapse (POP). SUI is a type of incontinence caused by leakage of urine during moments of physical stress. POP occurs when a pelvic organ, such as the bladder, drops from its normal position and pushes against the walls of the vagina. This can happen if the muscles that hold the pelvic organs in place become stretched or weakened because of childbirth or surgery. More than one pelvic organ can drop at the same time. Organs involved include the bladder, uterus, bowel and rectum. POP can cause pain or problems with bowel and bladder functions or cause sexual intercourse to be uncomfortable.

A surgery that treats both conditions involves implanting surgical mesh into the vagina to hold up the prolapsed organs. The FDA recently issued a warning to patients that it had received reports of complications associated with the transvaginal implantation of the mesh for the treatment of POP and SUI. These complications can have serious consequences.

The most frequent complications include erosion through the vagina, infection, pain, urinary problems, and recurrence of the prolapse and/or incontinence. In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgeries to remove the mesh. Other complications included injuries to neighboring organs such as the bowel and bladder or the blood vessels. Several women who allege they have suffered injuries have filed lawsuits against the manufacturers of transvaginal mesh.

Women who suffer from POP or SUI should discuss their concerns with their doctors before having repair surgery, and tell their doctors if they have had any past reactions to mesh materials such as polypropylene. The FDA also suggests women ask their doctors the following questions to determine whether surgery with transgavinal mesh is right for them:

  • What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully performed without using mesh?
  • If a mesh is to be used, what’s been your experience with implanting this particular product? What experience have your other patients had with this product?
  • What’s been your experience in dealing with the complications that might occur?
  • What can I expect to feel after surgery and for how long?
  • Are there any specific side effects I should let you know about after the surgery?
  • What if the mesh doesn’t correct my problem?
  • If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?
  • If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?

Women who have had POP or SUI repair surgery and experienced problems should file a report with the FDA MedWatch Adverse Events Reporting Program at www.FDA.gov/MedWatch/Report/htm.

Source: FDA