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Transvaginal Mesh

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Transvaginal mesh is a permanent surgical implant designed to reinforce a weak vaginal wall and to repair pelvic organ prolapse (POP) or to  support the urethra to treat stress urinary incontinence (SUI). In July 2011,  the FDA  issued updated warnings regarding the serious complications associated with transvaginal mesh for repair of POP and SUI.  In 2012, the FDA ordered the manufacturers to conduct postmarket surveillance studies (522 studies)  about the rates of organ damage and complications linked to the implants.  More than 1 million women have received transvaginal mesh inserts during the past 15 years.

Erosion of mesh through the vagina is the most commonly reported mesh-related complication.  Mesh erosion can require multiple surgeries to repair and can be debilitating.  In some cases, even multiple surgeries will not resolve the complication.  Another reported complication is mesh contraction (shrinkage), which is associated with vaginal shortening, tightening, and pain.  Both mesh erosion and mesh contraction may lead to severe pelvic pain and/or painful sexual intercourse.  

In the last few years, a wave of lawsuits have been filed in federal and state courts involving pelvic mesh products.  Johnson & Johnson (J&J) alone faces more than 12,000 lawsuits, many of which have been consolidated in a multidistrict litigation (MDL) in a West Virginia federal court: In Re Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, U.S. District Court, S.D. of West Virginia (Charleston).  Other manufacturer-defendants that have had their cases consolidated in the MDL proceedings include Boston Scientific, Coloplast, Cook Medical, C.R. Bard, and Endo Health Solutions.   In March 2014 Coloplast agreed to pay $16 million to settle some of the lawsuits, while officials from Boston Scientific, Endo, and C.R. Bard are reportedly continuing settlement discussions.  J&J has not publicly commented on its position.

While the federal MDL information gathering proceeds, state court juries are beginning to return verdicts.  
  • In February 2013, a New Jersey jury awarded $11.1 million in damages over Johnson & Johnson's Gynecare Prolift device.  It was the first case of J&J's implants to go to trial.  Plaintiff Linda Gross suffered constant pain and underwent 18 operations after the Gynecare Prolift was implanted.  The award included $3.35 million in compensatory damages and $7.76 million in punitive damages.  Gross v. Gynecare Inc., Sup. Ct. of N.J., Atlantic County, ATL-6966-10.  
  • In April 2014, a Texas jury awarded $1.2 million to the plaintiff in a case involving Johnson & Johnson's TVT-O sling.  The jury found that the product was defectively designed and awarded compensatory damages but declined to award punitive damages because it found that the company adequately warned of the product's risks.  Batiste v. McNabb, No. 12-14350, District Court for the 95th Judicial District, Dallas County Texas (Dallas).

If you have had a pelvic mesh implant and would like to know more about pending litigation contact us.  Statutes of Limitations limit the time you have to file a legal claim.

Alerts

FDA Proposes to Reclassify Transvaginal Mesh to Class III High-Risk Device
04/29/2014

FDA Issues Warning Letter to Vaginal Mesh Maker Endo 
04/17/2014

Texas Jury awards $1.2 M in J&J/Ethicon Pelvic Mesh Lawsuit
04/07/2014

Legal News: Coloplast Agrees to $16M Settlement of Transvaginal Mesh Claims
3/6/2014

Legal Actions: States Investigate Pelvic Mesh Products Made By Endo
3/5/2014

FDA Recommendations for Women with Pelvic Organ Prolapse (POP)
8/26/2013

FDA Recommendations for Patients for Stress Urinary Incontinence (SUI)
3/27/2013

Legal News: Pelvic Mesh Claims Against Endo, Boston Scientific, and Johnson & Johnson Consolidated in Multidistrict Litigation
2/9/2012

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If you have experienced adverse events or side effects from a surgical mesh product find help here.
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Statutes of Limitations limit the time period that plaintiffs have to file a legal claim.  These time limits vary from state to state, but generally range from 2-6 years.  In product liability cases, the statute of limitations usually begins when the injury occurs, but in some cases may not start until the affected person discovers, or should have discovered, that the product caused their injury.  
Need help finding a medical or legal professional?  Email us at info@medwarn.org

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