American Medical Systems’ Transvaginal Mesh Allegedly Caused Pennsylvania Woman Severe and Painful Injuries, According to Lawsuit Filed by Parker Waichman LLP

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Parker Waichman LLP has filed a lawsuit on behalf of a Pennsylvania woman who alleges that a transvaginal mesh device manufactured by American Medical Systems caused serious injuries. The Complaint alleges that the company knew its mesh product was defective, but that it did not inform consumers.

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According to the Complaint, the Plaintiff was implanted with the SPARC and IntePro LLP Y-Sling in May 2011.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by dangerous drugs and medical devices, has filed a lawsuit on behalf of a Pennsylvania woman who alleges that she was injured by a transvaginal mesh product manufactured by American Medical Systems (AMS). The suit was filed on May 17, 2013, in the U.S. District Court for the Southern District of West Virginia (Case No. 2:13-cv-11742) in the multidistrict litigation (MDL) entitled In Re: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2325). American Medical Systems, Inc. has been named as Defendant.

According to the Complaint, the Plaintiff was implanted with the SPARC and IntePro LLP Y-Sling in May 2011. The lawsuit alleges that these devices are defective and caused serious and possibly permanent injuries. Furthermore, the Defendants allegedly knew about these defects but did not warn consumers in order to protect their own financial interests. The Plaintiff is suing for pain and suffering, emotional distress, and economic loss, and is seeking compensation for punitive damages.

Thousands of transvaginal mesh lawsuits have been filed in the United States. Many of them have been consolidated into five MDLs now pending in U.S. District Court for the Southern District of West Virginia. The other MDLs are: In Re: Boston Scientific Products Liability Litigation, MDL No. 2326; In Re: C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2187; In Re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2327; and In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation, MDL No. 2387.

According to a June 10, 2013, Pretrial Order issued to AMS, presentations regarding the selection of Bellwether Cases are to be made on June 25, 2013, with the court expected to select five transvaginal mesh bellwether cases.

Transvaginal mesh devices were approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions most commonly caused by weakened pelvic muscles. Transvaginal mesh devices are supposed to help correct these conditions by providing additional strength to the pelvic walls. The U.S. Food and Drug Administration(FDA) reports that the most common complications associated with transvaginal mesh may include:    

  • Mesh erosion through the vagina (also called exposure, extrusion, or protrusion)        
  • Pain        
  • Infection        
  • Bleeding        
  • Pain during sexual intercourse (dyspareunia)        
  • Organ perforation        

According to a July 13, 2011, FDA safety alert, complications linked to transvaginal mesh implants are “not rare” and the use of such devices may actually be more harmful compared to alternative methods for treating POP. The FDA has also asked 33 manufacturers, including Johnson & Johnson, to conduct post-market safety studies in order to investigate the effect of vaginal mesh on organ damage and other health concerns.

The first transvaginal mesh lawsuit to go to trial led to an $11.1 million verdict in favor of the Plaintiff (Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey), according to a Feb. 28, 2013, Bloomberg report. The Plaintiff’s case was the first of 4,000 Gynecare Prolift cases expected to go to trial. Johnson & Johnson was ordered to pay $3.35 million in compensatory damages and $7.76 million for punitive damages.

Parker Waichman LLP continues to offer free lawsuit consultations to victims of transvaginal mesh injuries. If you or a loved one experienced complications following POP and SUI surgery with mesh, please visit the firm's transvaginal mesh injury page at yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).

Contact: Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636
http://www.yourlawyer.com

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