» FDA Now Moves to Reclassify Transvaginal Mesh Kits as High Risk

FDA Now Moves to Reclassify Transvaginal Mesh Kits as High Risk

Austin, TX (Law Firm Newswire) July 14, 2014 – The FDA has announced new regulations pertaining to surgical mesh used in transvaginal surgery to repair pelvic organ prolapse.

“The new regulations are supposed to impose greater levels of scrutiny on such products and mandate that manufacturers submit a pre-market approval application to have their product evaluated. Prior to issuing these new regulations, the transvaginal mesh kit was rated as being a moderate risk device. However, in the face of thousands of lawsuits against various mesh makers, the FDA had to move to do something. Because the mesh was rated as a moderate risk, there was no requirement to conduct human clinical trials before marketing it,” explains Bobby Lee, a personal injury lawyer with Lee, Gober and Reyna in Austin.

The move to reclassify the transvaginal mesh products as high-risk means any further mesh products would not be marketed without trials and that if current mesh makers intend to keep selling their products, they must conduct safety studies. “While this is good news, it is a bit like closing the barn door after the horse has escaped. Testing existing products in light of the thousands of lawsuits for defective surgical mesh would seem to be redundant since it was inappropriately tested in a live, unsuspecting market over the last few years, with disastrous consequences,” points out Lee. “Clearly, settling the large number of lawsuits relating to defective mesh products may take many years.”

Recent court documents indicate there are over 50,000 transvaginal mesh lawsuits filed in the U.S. District Court, Southern District of West Virginia by women allegedly injured by mesh products.

The lawsuits are:
· In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2440)
· In Re: Coloplast Corp. Pelvic Support System Products Liability Litigation (MDL No. 2387)
· In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2187)
· In re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326)
· In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation - MDL No. 2327)
· In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2325)

Lee, Gober & Reyna
11940 Jollyville Road #220-S
Austin, Texas 78759
Phone: 512.478.8080

  • Young drivers have more accidents due to risky driving behavior
    Younger drivers, who do not have a lot of driving experience, exhibit more risky driving behavior than older, experienced drivers. Inexperience and distracted driving together cause accident rates to escalate exponentially. Car crashes are the leading cause of death for those 16 to 19-years-old. Mobile technology has many advantages if used properly, but it causes major distractions for drivers who need to be concentrating on the road and not on the screen of their smartphone. Anything that takes a driver’s attention and focus off the road can lead to an accident. According to the Centers for Disease Control and Prevention […]
  • Are billboards a driving distraction?
    Those who sell digital signboard space want more roadside billboards to capture the attention of drivers. Those who have seen drivers get into accidents as a result of distracted sign watching disagree. Digital billboard proponents say the signboards need to be plentiful in the largest cities in Texas because they attract more customers for local businesses. However, law enforcement, who see many accidents resulting from distracted driving due to looking at billboards, disagree with adding more to the cityscape. While there are billboards in some Texas cities, digital sign distractions are banned in Austin, Houston and Fort Worth. San Antonio […]
  • Are smartphone makers doing enough to prevent fatal accidents?
    With the technology growth in the development of personal devices, an interesting question arises. Are smartphone makers doing enough to prevent fatal accidents? Just recently a lawsuit was launched against Apple after a fatal collision in which one of the drivers was texting while driving. The lawsuit questions Apple’s liability in such accidents. It will be up to the court to decide whether or not cellphone makers are doing enough to prevent drivers from being distracted by notifications, calls, texts and whether they are liable in whole or in part for the accident. Legal pundits suggest Apple would likely not […]
  • Man involved in a head-on crash seeks to be hidden by store clerks
    The head-on crash in this story happened in an intersection in eastern Montgomery County. The wreck involved a 56-year-old man and a teenager. The teen managed to make it out of the crash unscathed, but the man left the scene. He ran to a gas station across the street, where he begged the store clerks to hide him. It was revealed later that the man had a blood alcohol content of .184, twice the legal limit. As it subsequently turned out, this particular felony crash was the man’s ninth DWI conviction. He received a life sentence to prevent him from […]
  • Lawsuit alleges trucker drove recklessly
    According to the statement of claim in this lawsuit, a Longview couple were left badly injured when a trucker, employed by a bottled water supply company, crashed into their vehicle. The suit alleges the company negligently entrusted a delivery truck to a reckless employee. It is further alleged the trucker was texting while driving, did not apply his brakes in a timely manner, was tailgating and did not maintain proper control of his truck. The accident happened in 2014 when the truck collided with the couples’ vehicle causing them to sustain severe physical and mental pain, loss of consortium and […]

See other news sources publishing this article. BETA | Tags: , , , , ,



Get headlines from Law Firm Newswire sent right to your inbox.

* indicates required