Articles Posted in Transvaginal Mesh Litigation

In a recent Journal of the American Medical Association Surgery (JAMA Surgery) article, the safety concerns of the use of the transvaginal mesh in pelvic organ prolapse (POP) repair has been noted by the U.S. Food and Drug Administration (FDA).The recent article by two physicians was published in the Journal of the American Medical Association Surgery edition published online on Nov. 30, 2016.

The article highlights studies that reveal the incidences and timing of complications related to the use of the transvaginal mesh organ prolapse repair, the amount of vaginal mesh used with mesh erosions and repeated surgery after pelvic organ prolapse repair and urinary incontinence surgery. The study is discussed expertly in the JAMA article by the authors, physicians Bhumy A. Davé, M.D., a female pelvic medicine & reconstructive surgeon associated with Northwestern Medicine, and Anne-Marie Boller, M.A., M.D., FACRS, a colon and rectal surgeon also with the Northwestern Medical Group in Chicago.

The article points out that the recent transvaginal mesh study focused on the clinically important mesh complications (those that require an intervention as opposed to asymptomatic erosions) and it references a statewide database, which minimizes under reporting that occurs when patients change doctors secondary to complications.
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Barbara Watt underwent a hiatal hernia repair surgery. The procedure was carried out by general surgeon Dr. Cimenga Tshibaka, and it was unsuccessful. Dr. Tshibaka performed a second surgery, this time using a synthetic surgical mesh. The second surgery was about 2 weeks after the first.

The following month, Watt was diagnosed as having an esophageal leak, which required nine additional surgeries to, among other things, remove the synthetic mesh that had eroded into her esophagus.

As a result of these many surgeries, Watt must now eat slowly and in limited amounts. She must also wear special undergarments due to scarring and is unable to bend over to lift more than 5 pounds. She also missed time from her job as a financial operations specialist where she was earning $21 per hour.

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A recent count showed that more than 25,000 transvaginal mesh cases are pending in the Southern District of West Virginia.  These cases involve the vaginal mesh manufacturers C.R. Bard, Inc., American Medical Systems, Inc., Boston Scientific Corp., Ethicon, Inc., Coloplast Corp. and Cook Medical, Inc.

There are several thousand more cases pending in state court cases around the country, including the states of New Jersey, California, the Commonwealth of Massachusetts and Minnesota.  The first round of bellwether trials involving the transvaginal mesh manufacturers Bard, Boston Scientific and AMS are being scheduled in the Southern District of West Virginia. These cases will be tried in November 2013, as well as February and April 2014.  These will be the first of the bellwether trials involving these three defendants.

There have been other bellwether trials against the defendant C.R. Bard. In the first case, Cisson, et al. v. C.R. Bard, Inc., the jury returned a verdict in favor of the plaintiff, Donna Cisson. In a second case involving C.R. Bard, a settlement was reached with the injured party.

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On July 8, 2013, the U.S. District Court in Charleston, W.Va., started the first bellwether jury trial in the C.R. Bard, Inc. Multidistrict Litigation (MDL). Bard manufactures transvaginal mesh products. Not long after the beginning of the trial, the trial judge declared a mistrial. After opening statements and the testimony of at least one witness, a physician then testified inadvertently that the manufacturer (Bard) was no longer selling this type of mesh product, which was at issue in the case.

The court declared the mistrial because the testimony violated a pretrial order that prohibited evidence of a subsequent remedial measure. The case was restarted again in mid-August, but this time the jury returned a $2 million verdict for the injuries suffered by Donna Cisson, a public-health nurse from Georgia. She received the Bard Avaulta Plus implant in 2009. Jurors deliberated for 12 hours over two days before reaching their verdict. The vaginal mesh implant is made by Bard. Bard’s attorneys have said on the record that the company intends to appeal the verdict ($250,000 in compensatory damages and $1.75 million in punitive damages), which they say was wrong because Cisson’s injuries were not caused by Bard’s product.    

The transvaginal mesh products are used in surgical procedures to repair conditions in women that have pelvic organ prolapse and stress urinary incontinence. Bard has removed its Avaulta Plus implant product off the market in 2012 after the FDA ordered that all makers of these implant products review reports of organ damage, infection and pain during sex.

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