FDA has classified Transvaginal Mesh as "High Risk", Doctors warn of safety concerns.

Physician and FDA Warnings Regarding the Safety of Transvaginal Mesh Implants

  April 8th, 2015


Many people do not realize that TVM devices currently on the market are generally modeled after an original TVM product that was subsequently recalled because patients suffered serious injuries. Despite this history, FDA rules permitted some devices that were comparable to be marketed to the medical community and patients without inclusion in human testing or clinical trials.


TVM Comes Under Increased Scrutiny from FDA

The safety of current vaginal mesh products first came to the attention of the FDA in 2008, when the agency analyzed approximately 1,000 adverse event reports regarding complications associated with the medical device. The federal agency acknowledged that transvaginal placement of this medical device could cause significant adverse effects but characterized the problems as “rare.”

The FDA received thousands of more adverse reports by 2011 which led the agency to revise its prior conclusion that the serious consequences associated with TVM were “rare.” Moreover, the agency indicated that sparse evidence existed that TVM procedures were even an effective treatment to repair POP. The FDA indicated that between the two reports, the complications most often reported included severe infection, mesh erosion into the vagina, urinary problems, severe pain and perforation of organs. Along with bleeding and painful intercourse. Federal medical regulators also indicated that other complications like vaginal scarring, emotional disturbances, recurrent prolapses and neuro-muscular issues were associated with TVM implants.

Federal regulators changed the classification of TVM from a Class II moderate risk device to a Class III high risk device in early 2012. This classification means that a medical device must be subjected to rigorous pre-market testing prior to being marketed to consumers. Unfortunately, this change has yet to be implemented.


Lawsuits Allege Lack of Clinical Trials of TVM Implantation


Meaningful clinical trials prior to marketing a medical device is an important form of protection for consumer safety. Many lawsuits against manufacturers of TVM allege that a lack of clinical trials has resulted in patients suffering adverse events.

An article was published in the Journal of Obstetrics and Gynecology in August of 2010 entitled “Vaginal Mesh for Prolapse, a Randomized Controlled Trial.” The trial included 65 women, and 32 had received implantation of vaginal mesh. The trial was terminated a short time after it was initiated because almost 16 percent of the women in the study experienced erosion of the mesh during the initial 90 day period following implantation.

The FDA reclassification of TVM devices used for treatment of POP to Class III means that any new device or significant alterations to current TVM products must undergo pre-clinical testing. During the last few years, tens of thousands of transvaginal mesh lawsuits have been filed against TVM manufacturers. These lawsuits have already resulted in multi-million dollar settlements and verdicts. Lawsut.Watch Has Helped hundreds of women find a Transvaginal Mesh Attorney click here to file a Lawsuit.Watch Transvaginal Mesh Lawsuit.


Transvaginal Mesh Lawsuits Have Already Resulted in Significant Verdicts and Settlements

Approximately, 73,000 lawsuits have been filed in federal court against companies that manufacture transvaginal mesh products. This number continues to rise as an increasing number of women injured by this medical product come forward to assert their legal rights and to seek financial compensation. Some notable settlements and verdicts have already resulted in significant compensation, such as:

  • August 2015:  C.R. bard agrees to pay $200 Million to settle a portion of their Pelvic mesh (TVM) claims. This is the second largest Transvaginal Mesh Settlement up to this date. Read More .
  • October 2014: Endo Health settled claims for TVM injuries for over $400 million to settle a plethora of TVM lawsuits. The company has already incurred over a billion dollars in costs related to TVM claims.
  • November 2014: Boston Scientific was the subject of a $26.7 million verdict in favor of four women injured by the company’s Pinnacle® mesh implant. Read more about Boston Scientific Transvaginal Mesh Settlement.
  • February 2013: A jury awarded $11 million to a woman who had to have 18 revisionary surgeries after being implanted with TVM manufactured by Johnson and Johnson’s subsidiary Ethicon.
  • August 2013: A jury returned a verdict for $2 million against C.R. Bard brought by a woman who suffered injury from one of the company’s vaginal mesh products.
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Judge in MDL Warns TVM Shareholders

U.S. District Judge Joseph Goodwin, who is overseeing the MDL in West Virginia recently issued a warning to shareholders of C.R. Bard that failure to settle pending claims could lead to enormous financial losses according to a recent Bloomberg article. The warning was issued at a December 9, 2014 hearing in the wake of several multi-million dollar jury awards in TVM lawsuits against C.R. Bard. “I can’t imagine a corporation facing potentially billions of dollars in verdicts wouldn’t find it advisable to try to achieve a settlement for a much lesser sum, said Judge Godwin. “I based that billions of dollars business on some of the rather large verdicts that we’ve had.”

Recent Large Jury Verdicts/Settlements

A number of recent settlements and verdicts in TVM lawsuits offer encouragement to many patients who have suffered serious harm caused by this medical device. Some recent examples include: February 18, 2015: C.R. Bard settles a bellwether case for an undisclosed amount one day prior to the date set for trial. Bellwether trials provide a way to gauge likely jury responses to witnesses and testimony likely to be presented in multiple cases. The victim claimed that transvaginal mesh posed an unreasonable risk of complications that include bleeding and scarring. (Reuters)


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