Parker Waichman LLP

Victims of Transvaginal Mesh Complications Doubt FDA

  Woman Who Experienced Transvaginal Mesh Complications Questioned FDA. Research published in Obstetrics and Gynecology on May 4, 2016 by Northwestern University criticizes the agency for approving a number of high-risk women’s health devices based on weak clinical studies, including transvaginal mesh. Lead researcher Dr. Steve Xu said, “Although it is impossible to know retrospectively whether […]

Transvaginal Mesh Complications

 

Woman Who Experienced Transvaginal Mesh Complications Questioned FDA. Research published in Obstetrics and Gynecology on May 4, 2016 by Northwestern University criticizes the agency for approving a number of high-risk women’s health devices based on weak clinical studies, including transvaginal mesh.

Lead researcher Dr. Steve Xu said, “Although it is impossible to know retrospectively whether more rigorous regulation would have prevented complications associated with transvaginal mesh, it may have provided earlier warning of patient safety risks.” Now, women who have experienced transvaginal mesh complications question why the U.S. Food and Drug Administration (FDA) took so long to classify the mesh as a high-risk medical device.

According to the FDA website, the agency claimed the current mesh product was similar to older mesh products and was cleared under the fast-track process, allowing transvaginal mesh to be cleared as a safe and effective device. Meanwhile, it took the FDA until the beginning of 2016 to classify the transvaginal mesh as a Class III, or high-risk medical device, which mandates a more stringent clearance process involving clinical trials.

Device Regulation Is So Much Weaker Than Drug Regulation

The Northwestern University researchers studied 18 high-risk devices that were approved between 2000 and 2015. Of those, four did not demonstrate effectiveness, six were not require to post-marketing safety studies, and three were withdrawn from public sales by manufacturers because of safety or other issues.

“Device regulation is just so much weaker than drug regulation, and it doesn’t make any sense,” said Dr. Xu. The question is why should high-risk medical devices be held to a lower standard of evidence than drugs? Dr. Xu also expressed concern that the 21st Century Cures Act, legislation that has passed the House and is being considered in the Senate, would make device regulation weaker than it already is.

Need Legal Help Regarding Transvaginal Mesh Complications?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
I am more than satisfied with Parker Waichman, especially my attorney Shelly Davis. They literally made this difficult process effortless for me. I was kept informed immediately as soon as they were informed. The process went much faster than I thought it would and that is directly a result of Parker Waichman staying on top of my case. I would highly recommend this firm, they don,t treat you as a case they treat you as a person in need of assistance.
Deborah White
3 years ago
5 Star Reviews 150
Want to thank you, Shelly Davis, for all that you did for me to receive my compensations thru out my career in The NYPD ! Greatly appreciated!!
Danny Torres
a month ago
5 Star Reviews 150
Positive: Professionalism Benita Rollis was very professional and caring. She returns my calls promptly and kept me updated on my case. Parker and Waichman please keep up the good work you have great person working for your company. I have no regrets
D Ferg
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038