Physician Malpractice in Focus for Polypropylene Mid-Urethral Slings

Manufacturers entered into various Consent Orders and Judgments with the States that requires additional language in their IFU for its mid-urethral slings

SANTA BARBARA, CA, UNITED STATES, March 28, 2022 /EINPresswire.com/ — Ethicon and Boston Scientific entered into various Consent Orders and Judgments with the States that requires additional language in their Instructions for Use (IFU) for its mid-urethral slings. Ethicon’s Consent Agreement, for example, requires the company to do the following:

a. Do not represent that any inflammatory or foreign body reaction is only transient or, in all instances, minimal.
b. Do not represent that a foreign body reaction “may occur” with implantation of the device, but instead indicate that a foreign body reaction to the device will occur, the extent of which may differ and may result in adverse reactions, which may be ongoing.
c. State the Risks include excessive contraction or shrinkage of the tissue surrounding the mesh.

Greg Vigna, MD, JD, national pharmaceutical injury attorney, national neurological medical malpractice attorney, practicing physician, and Certified Life Care Planner states, “We represent dozens of women with serious injuries from mid-urethral slings. Those injuries include ilioinguinal neuralgia, pudendal neuralgia, and obturator neuralgia which result from the acute, chronic and unpredictable foreign body response from the heavyweight polypropylene mesh that have been used by both Boston Scientific and Ethicon for over two decades.”

Dr. Vigna adds, “In case after case these manufacturers blame the implanting physicians for misplacement of the device as well as treating physicians for alleged surgical errors and mismanagement of injuries. These manufacturers make these allegations for purposes of litigation and their experts are happy to jump on board with these defenses—blaming doctors in almost every case. Interestingly, those same manufacturers lovingly embrace implanting and treating physicians when they are trying to sell the products. Given the way these manufacturers carry on, it is becoming necessary to consider bringing the implanters into the case when there is a reason to do so—especially given the litigation tactics described. Going forward we will continue investigating the implantation of a transobturator slings for physician malpractice but will be considering retropubic sling and mini-sling cases for the negligent decisions to implant the defective devices.”

Dr. Vigna concludes, “The focus of my law firm is national litigation for those who have suffered serious neurological injuries caused by those manufacturers such as Boston Scientific and Ethicon as well as possible liability against physicians and hospitals for negligence in placing mid-urethral slings. We are now at the point where the mere choice to implant a polypropylene mid-urethral sling is unjustified with all the defective qualities that by now should be known. One place doctors can look to see what problems exist with these mesh products is in the published Consent Agreements. Our position is supported by Ethicon’s Consent Agreement that states the risks of midurethral slings include ‘complications that cannot be eliminated with surgical technique and complications that are specifically associated with the use of Surgical Mesh (as opposed to non-mesh surgery)’. We are talking about ‘nerve entrapment’ from excessive tissue contraction and excessive tissue shrinkage that, to this day, there has been no warning that a properly placed mid-urethral sling may cause nerve entrapment and neuralgia.”

Dr. Vigna is a California and Washington DC lawyer and, along with Martin Baughman, PLLC, a national pharmaceutical injury law firm in Dallas, focuses on the neurological injuries caused by transvaginal mesh devices including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and Complex Regional Pain Syndrome.

Learn more on the anatomical basis for TOT injury or irritation to the obturator and pudendal nerve and the treatments of obturator and pudendal neuralgia.

Read our FREE BOOK on Vaginal Mesh Pain or listen to the Vigna Law Group Podcast.

For articles, video resources, and information visit the Pudendal Neuralgia Educational Portal at or Visit regarding sling related complications.

References:
https://www.augs.org/assets/1/6/Joint_Position_Statement_on_the_Management_of.99428.pdf
https://www.clydeco.com/clyde/media/fileslibrary/Consent_Judgment_-_Ethicon.pdf

Greg Vigna, MD, JD
Vigna Law Group
+1 800-761-9206
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