Second Transvaginal Mesh Trial Underway

transvaginal_mesh_bard_trial_newThe second of four trials involving lawsuits brought over injuries alleged tied to transvaginal mesh implant devices is underway.

The trials are underway before U.S. District Judge Joseph Goodwin, according to The Daily Mail. Jurors have been picked in the case against device maker, C.R. Bard Inc. The plaintiff is a North Carolina woman who was surgically implanted with the so-called “sling” device as a treatment for her pelvic organ prolapse (POP).

Last week, a jury awarded a 54-year-old Georgia woman $2 million in a case brought over similar allegations. The majority of the $2 million–$1.75 million—was awarded for punitive damages against C.R. Bard for failing to adequately advise physicians and patients of potential complications associated with its transvaginal mesh device, according to The Daily Mail.

In that case, the plaintiff contended that, following transvaginal mesh device implantation to help resolve stress urinary incontinence (SUI), she suffered from an array of medical issues including, bleeding, pain, and additional pelvic issues. She underwent surgery to remove the device; however, surgeons were unable to fully remove the mesh, The Daily Mail reported. Her attorney advised the jury that the arms of the transvaginal mesh device were like “rebar in concrete” and that his client would be faced with the side effects of the device for the rest of her life.

This was the first bellwether case scheduled by Judge Goodwin. More than 20,000 related cases involving six transvaginal mesh manufacturers have been assigned to Judge Goodwin; the first four involve C.R. Bard, The Daily Mail, reported.Once the four trials are complete, Judge Goodwin will decide on the way in which to proceed with the rest of he litigation.

Thousands of women were recipients of transvaginal mesh devices, which have come under intense scrutiny, as many women who were implanted with these devices are reporting complications allegedly related to their defects. Transvaginal mesh devices were approved to treat SUI and POP, conditions most commonly caused by weakened pelvic muscles. The devices are meant to help correct these conditions by providing additional strength to the pelvic walls.

The vaginal mesh devices were approved through a U.S. Food and Drug Administration (FDA) fast-track process known as the 510(k), under which a formal review for safety and efficacy is neither required nor performed. Because the 510(k) route has been used to gain clearance for transvaginal mesh and other controversial devices, the process has drawn increasing criticism.

An array of companies—Boston Scientific, Endo Health Solutions, Cook Medical, and Johnson & Johnson’s Ethicon subsidiary—face about 4,000 federal lawsuits over their transvaginal mesh devices, according to MassDevice.com.

The FDA has stated that complications linked to transvaginal mesh implants are “not rare” and warned that use of such devices may actually be more harmful when compared to alternative methods for treating POP. The FDA also recently reported that the most common complications associated with transvaginal mesh may include:

  • Exposure, extrusion, or protrusion (mesh erosion through the vagina)
  • Pain
  • Infection
  • Bleeding
  • Pain during sexual intercourse (dyspareunia)
  • Organ perforation
  • Urinary problems

 

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