FDA Mesh Recall List

October 22, 2012

The FDA has declared surgical mesh used in the treatment for pelvic organ prolapse and stress urinary incontinence as an area of ongoing concern. In July of 2011, the US Food and Drug Administration also stated that the serious risks and complications following mesh surgery for POP are not rare, a change from their previous 2008 safety warning. In September of last year, the Obstetric-Gynecology Devices Panel of the Medical Device Advisory Committee met in order to further discuss both the effectiveness and the safety of using urogynecologic mesh devices. The panel also sought to choose a position on the marketing and use of these devices in the future. Although there has not been an FDA recall of mesh products, they were reclassified as Class III devices in January of 2012.

FDA Mesh Recommendation List

Recall that vaginal mesh is a permanent implant that can result in making future procedures more difficult or challenging.

Consider other treatment options because usually pelvic organ prolapse and stress urinary incontinence can be treated successfully without the use of vaginal mesh.

  • Other treatments for SUI and POP do not have the same risks and complications.
  • There are both other surgical and non-surgical treatments for SUI and POP.

Only elect to have mesh implanted after carefully studying all of the serious complications and potential risks associated with the transvaginal placement of surgical mesh.

Ask your physician the following mesh related questions before surgery:

  • Will mesh be used in this procedure?
  • Why are you choosing to use mesh rather than a non-mesh treatment option?
  • What other alternatives are there for my treatment, both surgical and non-surgical?
  • Will the mesh implant used in my treatment be felt by my sexual partner during intercourse?

Mesh Complications: Is a Recall in Sight?

Several companies, including Johnson & Johnson’s Ethicon, have chosen to voluntarily recall some of their mesh products. However, to date, there has been no FDA recall of transvaginal mesh devices. However, many victims of mesh injuries and the attorneys that represent them are trying to have the FDA mandate a mesh implant recall for all of these potentially harmful devices.

Consult with a Mesh Recall Attorney

If you or a loved one has been harmed by POP or SUI surgery using transvaginal mesh, contact the Willis Law Firm today. You may be legally entitled to financial compensation, and we may be able to help you secure that settlement. All mesh clients are represented on a fee contingency basis. We are now reviewing mesh recall cases nationwide.

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