American Medical Systems and Boston Scientific Transvaginal Mesh Devices Alleged to Be Defective in New Lawsuit

A woman allegedly injured by several transvaginal mesh devices manufactured by American Medical Systems and Boston Scientific has filed a lawsuit in the federal litigation now underway in U.S. District Court for the Southern District of West Virginia, Charleston Division.  According to the complaint, American Medical Systems’ Elevate Prolapse Repair System and Perigee Prolapse Repair System, along with Boston Scientific’s Lynx Suprapubic Mid-Urethral Sling System, are defective and caused the Plaintiff to suffer permanent complications.  The Plaintiff is being represented by the National Law Firm of Parker Waichman LLP.

According to the complaint, the Plaintiff was implanted with the Elevate Prolapse Repair System, Perigee Prolapse Repair System and Lynx Suprapubic Mid-Urethral Sling System in April 2009 to treat pelvic organ prolapse and stress urinary incontinence.  The lawsuit alleges that all of the transvaginal mesh products the Plaintiff received suffer from the same defect- mainly, that the mesh is not inert and reacts with the tissues in the body. This, the suit states, creates an unreasonable risk of vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess. As a result, the transvaginal mesh device caused meshes caused harm to the Plaintiff, leading to significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and loss of bodily organ system.

Hundreds of woman throughout the country have filed similar lawsuits against tAmerican Medical Systems, Boston Scientific, and other manufacturers of  transvaginal mesh in the Southern District of West Virginia.  Cases have also been filed in state courts throughout the country.  Just last week, a California jury awarded $5.5 million dollars to a couple who filed a lawsuit alleging C.R. Bard’s Avaulta Plus transvaginal mesh caused serious damage.

All of the transvaginal mesh products named in lawsuits were approved through the U.S. Food & Drug Administration’s (FDA) 510(k) protocols. This means that the products were not subject to any type of human clinical testing for safety or efficacy before they were marketed because they were deemed “substantially equivalent” to older devices. Earlier this year, the FDA has asked 33 manufacturers, including American Medical Systems and Boston Scientific, to conduct post-market studies of transvaginal implants in order to understand their impact on organ damage and other relevant health concerns.  The order came after the FDA issued a warning in July 2011 that the devices may not be more effective than non-mesh methods used to treat pelvic organ prolapse while carrying additional risks.  At the time, the FDA said it had received 2,874 reports of complications associated with transvaginal mesh products between 2008 and 2011.

This entry was posted in Defective Medical Devices, Transvaginal mesh and tagged . Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.