C.R. Bard’s Transvaginal Mesh Devices Allegedly Utilize Plastic not Suitable for Human Implantation, Notes Parker Waichman LLP

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Parker Waichman LLP, which has filed numerous lawsuits as part of a Transvaginal Mesh-related Multidistrict Litigation in West Virginia against C.R. Bard and four other companies, notes that Bard was warned that a resin-based plastic it used in mesh implants was not suitable for human implantation. This information was found in unsealed court records in the form of internal company emails.

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Once again we are faced with the possibility that a company is more concerned with the bottom line than the health and wellness of the people being implanted with their products.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is reporting that C.R. Bard Inc., the subject of one of five transvaginal mesh-related multidistrict litigations (MDL) consolidated in West Virginia, is alleged to have used a resin-based plastic said to be unsuitable for human implantation in its mesh devices, according to court records. A June 26 Bloomberg report noted that this information will be used in the upcoming July 8 trial in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Cisson v. C.R. Bard Inc., Case No. 2:11-cv-00195), where it is one of many cases pending in the MDL called In Re: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation (MDL No 2187).

Bard managers used a resin-based plastic made by a unit of Chevron Phillips Chemical Co. to produce medical mesh devices – even after the supplier of the material warned that the plastic should not be permanently implanted inside people, according to emails and documents in the lawsuit over Bard’s mesh implants. Lawyers for the thousands of women who filed lawsuits as part of the MDL against C.R. Bard, faulting its Avaulta line of transvaginal implants for their injuries, said that court files show that not only did company officials know that the resin-based plastic used in the mesh wasn’t fit for human implantation – they also tried to cover up their use of it, according to the Bloomberg report.

According to Bloomberg, U.S. District Judge Goodwin ruled that the email correspondence regarding the resin-based mesh raised “a genuine issue of material fact about whether Bard was aware its conduct was practically certain to cause injuries.” Goodwin will oversee 20,000 lawsuits now pending in U.S. District Court for the Southern District of West Virginia. Aside from C.R. Bard, the other MDLs are: In Re: Boston Scientific Products Liability Litigation, MDL No. 2326; In Re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2327; In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation, MDL No. 2387; and In Re: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2325).

“Once again we are faced with the possibility that a company is more concerned with the bottom line than the health and wellness of the people being implanted with their products,” said Gary P. Falkowitz, a Managing Attorney at Parker Waichman LLP. “Companies that make medical devices should be extra vigilant about the materials they use.”

According to the U.S. Food and Drug Administration (FDA), 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 FDA also 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

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