Product Liability

Pelvic Mesh Recall and Warnings

Pelvic mesh surgery is a highly controversial process. Pelvic mesh implants are used to keep internal organs in place. There has been no official government recall of pelvic mesh, but the U.S. Food and Drug Administration (FDA) has issued several warnings about this product.1,2

Uses of pelvic mesh

Doctors use pelvic mesh surgically as a treatment for:3

  • Pelvic organ prolapse (POP)
  • Hernias
  • Stress urinary incontinence

POP happens when organs within the pelvis collapse downward. Hernias are caused by internal organs protruding through the walls of the spaces surrounding them. Stress urinary incontinence results from pressure on the bladder during exercise or other ordinary activities.

Warnings about pelvic mesh

The FDA issued two warnings about pelvic mesh: one in 2008 and one in 2011. The 2011 warning was worded more strongly than the 2008 warning. The product is still on the market.

The 2008 warning said more than 1,000 incident reports had been filed. The reports were from nine surgical manufacturers. The warning cautioned doctors to:1

  • Obtain specialized training
  • Be vigilant about potential adverse effects such as infection and erosion
  • Watch for complications such as blood vessel, bladder and bowel perforations
  • Tell patients the implantation is permanent and may require additional surgery
  • Tell patients about the potential for serious complications that may reduce their quality of life
  • Give patients a copy of the written labeling from the surgical mesh manufacturer

The 2011 warning expanded on the 2008 message to let health-care providers know that these complications are not rare and that using pelvic mesh may be unnecessary. It also said thousands of new reports had been filed since 2008.2

In addition to the earlier warnings, the 2011 statement added that doctors should:

  • Recognize that mesh is not usually required to treat pelvic organ prolapse
  • Consider other alternatives before using mesh surgery
  • Notify their patients about other alternatives, including nonsurgical options, abdominal placement of mesh, and non-mesh surgery
  • Consider that abdominal placement is safer than transvaginal placement
  • Consider that surgical mesh may complicate future surgeries, lead to complications or future surgeries, or lead to permanent quality-of-life impairment
  • Talk with patients about postoperative risks and complications

Legal issues

If you or one of your relatives has undergone pelvic mesh surgery and has experienced complications, you may be interested in taking legal action. A personal injury attorney can direct you toward resources that may be available.

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