» 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

  • A motorcyclist died in a crash with UPS truck
    A fatal crash occurred on Highway 813 in Waxahachie, Texas between a UPS truck and a motorcycle. According to police reports, the UPS truck was traveling west and the motorcycle was traveling east on Highway 813. The accident happened as the UPS truck proceeded to turn left and the motorcycle hit the side of the truck. The motorcyclist died at the scene. Motorcycle accidents are common. In fact, according to the Insurance Institute for Highway Safety (IIHS), motorcycle accidents have been on the rise since 1998. Drivers in other vehicles cause most motorcycle accidents. The IIHS recommends helmet use by […]
  • Boating accident in Texas reveals potential safety hazards
    Waterfowlers face many dangerous conditions when out hunting. Consider the recent accident involving a 26-year-old man and his 5-year-old son. Both drowned in Lake Tawakoni in Texas while waterfowling. Waterfowl hunting is a risky sport. Some of the dangers associated with the sport include: limited visibility, cold and unpredictable weather, overloaded and small vessels. If safety precautions are not strictly followed any accident can be a matter of life and death. The father and son had been caught in a storm, and their 12-foot aluminum boat was found by Texas game wardens the day after they were reported missing. The […]
  • Man on the run for seven years finally apprehended
    Vincente Gonzalez, a man on the run for seven years was hiding from intoxication manslaughter charges relating to a June 2009 accident that killed three. Gonzalez was finally apprehended by U.S. Marshals Joint East Texas Fugitive Task Force. The accident killing three — a 48-year-old male from Alto, a 29 year-old female from Lufkin and a four-year-old boy — happened in 2009. Gonzalez, the drunk driver, was taken to hospital for his injuries, a brain bleed and broken leg. He was not considered to be a flight risk and was not arrested. Gonzalez subsequently disappeared from the hospital and remained […]
  • Police Chief gets rear-ended by distracted driver
    A Police Chief, Michael Galvan, was rear-ended by a driver who was texting at the time of the accident. The crash happened in San Benito, Texas. The Chief was subsequently faced with $6,000 in repairs and had to deal with injuries to his lower back, wrist and shoulder. Partly in response to this particular incident and the very prevalent unsafe use of mobile devices while driving, San Benito city commissioners gave their approval to an ordinance banning texting while driving. The new ordinance does have a 90-day grace period to allow local residents to get used to the law. However, […]
  • Texas the state with the worst drivers in the United States
    According to the CarInsuranceComparison.com company, Texas — together with Louisiana — now ranks as the state with the nation’s worst drivers. CarInsuranceComparison.com, has been collecting driving information statistics for the past five years. This year is the first time for Texas to reach the No.1 place on the list. The yearly report is put together with information gathered by the National Highway Traffic Safety Administration (NHTSA). CarInsuranceComparison.com collects the material and compiles a score for each state based on the number of road deaths, DWI/DUI citations, careless driving, speeding and failures to obey traffic laws. Using those five categories, Texas […]

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



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

* indicates required