Austin, TX (Law Firm Newswire) January 5, 2017 – Over 23,641 physicians reported the adverse effects of the transvaginal mesh (TVM) device, used for stress urinary incontinence (SUI) or pelvic organ prolapse (POP).
In addition, 25,000 attorneys and over 1,000 hospitals sent negative reports of TVMs to the Food and Drug Administration (FDA). Furthermore, there was a high number of medical device distributor reports to the FDA, as well.
According to the FDA, there were 126,349 adverse events reported relating to TVM kit failures and 49 recalls for the various medical device manufacturers involved which included Boston Scientific, Bard, Medventure Technology and Johnson & Johnson. Johnson & Johnson alone had 42,890 complaints.
Former FDA Program Manager, Madris Tomes, now the founder of Device Events, firmly believes all TVM kits are dangerous. Additionally, although many of the adverse event reports deal with ongoing symptoms, a question arises whether TVMs could cause deaths.
Due to the nature of the reporting system, death may be reported as malfunctions and injuries. Based on current information in the FDA reporting system it is allegedly not clear how many deaths may be related to TVM kits. However, according to Medscape, an FDA review of records for all urogynecologic mesh products spanning the years 2005 to 2010, there were 3,979 reports of malfunctions, injuries and deaths.
“It was not until 2011 that the FDA announced that the serious complications with the TVM kits everyone was reading about in the news were not rare — a reversal of its original stance on the product issued in 2008,” said Austin TVM attorney, Bobby Lee. After the FDA released its revised position on TVM kits, it was revealed they had been sent over 4,000 complaints involving TVM malfunctions, injuries and/or deaths over a five-year period.
More recent figures relating to TVM lawsuits show there are almost 60,000 mesh lawsuits pending with thousands filed daily in the United States. There are even more such lawsuits being filed globally. The scope of the damage done by TVM kits is devastating, leaving thousands of women in pain for the rest of their lives, living with a foreign object in their bodies that they may not be able to have removed.
“If you have had a TVM implant and are having serious medical issues, our office is able to advise you of your legal rights in this regard. We can also discuss filing a lawsuit if you wish to proceed with one against the maker of your implant,” added Lee.
Lee, Gober & Reyna
11940 Jollyville Road #220-S
Austin, Texas 78759