The problems associated with transvaginal mesh implants have sparked an array of lawsuits against the manufacturers of the mesh as well as doctors who implanted the mesh in women. Since November 2014, plaintiffs have filed over 65,000 lawsuits regarding transvaginal mesh. Many cases have settled out of court with a monetary award to the plaintiff. Others have gone to court. Yet other cases are still pending litigation.
A Brief History of the Relevant FDA Warnings
The road to transvaginal mesh litigation began in 2005, when the FDA first received complaints about the side effects of surgical mesh use. From 2005 to 2008, the FDA received more than a thousand such complaints. In 2008, the agency issued a safety alert, stating that serious complications were associated with transvaginal mesh use.
In spite of this warning, doctors kept performing the surgeries. Between 2008 and 2010, the FDA received another 1,500 complaints about the mesh. The FDA took no action, except to reiterate its original safety warning. Finally, in January 2012, the FDA commanded companies that manufacture surgical mesh to conduct studies into the safety of the transvaginal use of this material. The FDA later added an addendum to its initial warning: treating prolapse with transvaginal mesh is actually riskier than using more traditional surgical options, and the process leads to no benefits beyond those that can be expected from the traditional methods.
Lawsuits Involving Transvaginal Mesh – Their Context and a Brief History
Many of the relevant lawsuits allege the following:
- Transvaginal mesh surgery was not tested enough to prove that the process meets basic standards of safety;
- Manufacturers failed to inform doctors and patients of the risks involved with the vaginal placement of the mesh for treating prolapse.
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The history of these lawsuits dates back to 2005, shortly after doctors began to use the mesh to treat prolapse. Most lawsuits have been handled quietly; however, some key cases do make the news.
In our next blog we will discuss what factors the Judges, presiding over Transvaginal Mesh lawsuits, when making financial award decision.
Know that you are not alone and our experienced attorneys are here to help. Call 1-855-423-3666 for a free and confidential case evaluation.
And for more information regarding the harm of transvaginal mesh implants download a copy of our free E-book, Transvaginal Mesh Lawsuits: What You Need to Know If You Have Suffered Harm from Vaginal Mesh Implants. Be sure to check back each week for more blogs regarding transvaginal mesh injury and what we can do to help.