Transvaginal Mesh Recall Petition From Public Citizen Supported by Schmidt & Clark, LLP

September 09, 2011 (PRLEAP.COM) Health News
The watchdog group Public Citizen is urging the U.S. Food & Drug Administration (FDA) to recall transvaginal mesh for the treatment of pelvic organ prolapse (POP), stating that the products needlessly expose patients to serious complications.

The nationally recognized plaintiff's law firm Schmidt & Clark, LLP strongly supports Public Citizen's position, and is currently accepting new transvaginal mesh failure claims from women who have suffered injuries or transvaginal mesh complications after undergoing a surgery where the medical devices were used.

Michael E. Schmidt, Managing Partner of Schmidt & Clark, LLP, has noticed and alarming number of inquiries to the firm related to transvaginal mesh. Mr. Schmidt stated, "Our firm has substantial expertise in the area of product liability litigation. As a result, we have received a number of inquiries from women who have received transvaginal mesh and suffered complications."

Public Citizen's petition, which was filed on August 25, 2011, requests a ban on the marketing of transvaginal mesh devices, an order to all manufacturers to recall the products, and a requirement that all future transvaginal mesh products be classified as Class III medical devices.

While vaginal mesh was originally approved by the FDA to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), in July 2011 the administration issued a press release stating that the devices expose patients to a number of extremely serious side effects. Making the matter more troubling, transvaginal mesh products are currently classified by the FDA under Class II, which allows them to be cleared for use as long as they are 'substantially equivalent' to existing products already on the market. Public Citizen's petition stated that these devices "have been cleared for marketing based solely on in vitro bench and/or animal testing to confirm that engineering specifications are met." The watchdog group is urging the FDA to reclassify transvaginal mesh products as Class III, which requires premarket approval and mandatory testing in well-designed studies with human subjects to assess whether they are safe and effective.

A number of transvaginal mesh device manufacturers including American Medical Systems, Inc., C.R. Bard, and Johnson & Johnson have been the subject of recent product liability and personal injury lawsuits. Some of the complications alleged in these transvaginal mesh lawsuits include:

  • mesh erosion through the vagina (also commonly referred to as exposure, extrusion or protrusion)
  • pain
  • infection
  • bleeding
  • pain during sex (dyspareunia)
  • organ perforation
  • urinary problems
  • recurrent prolapse
  • neuro-muscular problems
  • vaginal scarring / shrinkage
  • emotional problems

  • About Schmidt & Clark, LLP
    Schmidt & Clark, LLP represents individuals injured by transvaginal mesh complications nationwide. If you or a loved one has received a transvaginal mesh product during a POP or SUI surgery and subsequently developed any of the complications listed above, we urge you to contact us immediately for a free confidential consultation. You can speak with one of our lawyers by calling (866) 588-0600 or by visiting our website: