Are There Arguments Against Banning Transvaginal Mesh?

April 28, 2013  

As our Boston transvaginal mesh attorneys know, many hospitals and health professionals throughout the country have taken action to ban transvaginal mesh (TVM) products in light of the serious dangers presented by these medical devices. The FDA has also mandated that manufacturers conduct further studies to determine the danger of TVM, and some manufacturers including Johnson & Johnson have voluntarily pulled their products from the shelves as more and more patient complications arise. 1157469_you_are_ill_2.jpg

Yet, even with mounting concerns and with thousands of patient lawsuits throughout the country, some officials are actually making an argument that transvaginal mesh should not be banned. This argument comes from officials at the American Urogynecological Society (AUGs).

The Banning of Transvaginal Mesh Products
According to Ob.Gyn. News.com, the American Urogynecological Society believes that decisions on the use of transvaginal mesh should be made in consultation with a physician and should be made on a case-by-case basis. The Society recognizes that transvaginal mesh does present some very significant dangers but has issued a strong opposition to a blanket ban on the use of the products.

The Society released their statement after a medical malpractice company, state medical organization and health care system all either considered a ban on the use of transvaginal mesh or adopted a ban.

It is important to note that these bans are issued with very good reason. Transvaginal mesh products, which are used in the treatment of stress urinary incontinence and pelvic organ prolapse, have proven to be very dangerous.

Many women who have had these transvaginal mesh products implanted have experienced serious complications including pain, infection, erosion of the mesh and a repeat prolapse that necessitates further surgery. Further, when complications do develop, multiple revision surgeries are normally required because the mesh becomes part of the tissues of the body and is hard to remove.

Taking a risk of experiencing these side effects is often not worthwhile, especially with the high failure rate of transvaginal mesh products and when most evidence indicates that using transvaginal mesh is generally not any more effective than other methods of treating pelvic organ prolapse or stress urinary incontinence.

The bans, therefore, exist in order to try to protect women from a dangerous product.

AUGS Guidelines
AUGS suggests that hospitals and healthcare providers follow specific guidelines that have been issued in order to determine on a case-by-case basis when transvaginal mesh products should be used. These guidelines address auditing surgeons who perform procedures, using special credentialing procedures before a physician performs surgery, and creating special hospital review boards to review cases and complications.

AUGS also stresses the importance of obtaining informed consent from patients before transvaginal mesh products are used. While these are good principles to employ in practice and while no surgery should ever be performed with uninformed patients, it seems there are very few situations where the added risk of a transvaginal mesh product would be justified in light of the serious potential issues that may arise.

If you are dealing with transvaginal mesh complications in Massachusetts, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment -- 1-888-367-2900.

Additional Resources:
Transvaginal Mesh products--PBS Explores the Risks, Boston Personal Injury Attorney Blog, April 16, 2013.