FDA Now Moves to Reclassify Transvaginal Mesh Kits as High Risk | Law Firm Newswire

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

  • 4 Key Signs That You Need a Personal Injury Lawyer
    <p>When you’ve been injured due to the actions, inactions, or behavior of a negligent person or establishment, you might wonder if you should hire a personal injury attorney. The answer is yes, because you’ll need an attorney to work on your behalf to get the compensation that you deserve. It is always in your best …</p>
    <p>The post <a rel="nofollow" href="https://www.lgrlawfirm.com/2019/09/4-key-signs-that-you-need-a-personal-injury-lawyer/">4 Key Signs That You Need a Personal Injury Lawyer</a> appeared first on <a rel="nofollow" href="https://www.lgrlawfirm.com">Lee Gober & Reyna</a>.</p>
  • Common Types of 18 Wheeler Truck Accident Injuries
    <p>Most drivers on the road have certain expectations when it comes to automobile accidents. It’s no surprise that accidents involving semi or 18 wheeler commercial trucks can be extremely dangerous. Personal injury lawyers in the Austin area are available to help accident victims deal with a variety of injuries. Even when fully unloaded, semi-trucks are …</p>
    <p>The post <a rel="nofollow" href="https://www.lgrlawfirm.com/2019/08/common-types-of-18-wheeler-truck-accident-injuries/">Common Types of 18 Wheeler Truck Accident Injuries</a> appeared first on <a rel="nofollow" href="https://www.lgrlawfirm.com">Lee Gober & Reyna</a>.</p>
  • Why Car Insurance Claims Are Often Denied and How To Avoid It?
    <p>After an auto accident, you probably trust that your insurance company will take care of everything for you. Since you went with a name brand insurance company, pay your premiums each month, and try to drive safely, you haven’t considered looking into a car accident attorney. Sadly, most insurance companies are not your friends. Since …</p>
    <p>The post <a rel="nofollow" href="https://www.lgrlawfirm.com/2019/08/why-car-insurance-claims-are-often-denied-and-how-to-avoid-it/">Why Car Insurance Claims Are Often Denied and How To Avoid It?</a> appeared first on <a rel="nofollow" href="https://www.lgrlawfirm.com">Lee Gober & Reyna</a>.</p>
  • The Process of Personal Injury Claim in Austin, Texas
    <p>Part of the reason the legal process makes so many people anxious is that it’s something they rarely experience, and even when they do, they have a hard time understanding it. This is true in both civil and criminal matters and is one of the key reasons people fear lawyers the way they do. Being …</p>
    <p>The post <a rel="nofollow" href="https://www.lgrlawfirm.com/2019/07/the-process-of-personal-injury-claim-in-austin-texas/">The Process of Personal Injury Claim in Austin, Texas</a> appeared first on <a rel="nofollow" href="https://www.lgrlawfirm.com">Lee Gober & Reyna</a>.</p>
  • How Can An Attorney Help In A Car Accident Injury Situation?
    <p>Safety is the primary concern of anyone who has been in a car accident in Austin, Texas. Bad decision making after a collision can lead to medical complications, legal jeopardy, financial disaster, and loss of driving privileges or insurance coverage. The outcome could also have a negative impact on your job and family relationships. When …</p>
    <p>The post <a rel="nofollow" href="https://www.lgrlawfirm.com/2019/07/how-can-an-attorney-help-in-a-car-accident-injury-situation/">How Can An Attorney Help In A Car Accident Injury Situation?</a> appeared first on <a rel="nofollow" href="https://www.lgrlawfirm.com">Lee Gober & Reyna</a>.</p>

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



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

* indicates required