The United States Food and Drug Administration (“FDA”) often issues public health notifications (“PHNs”) and safety alerts when it finds that certain pharmaceutical drugs or medical devices may pose a risk to patients and consumers. Over the past eight years, there have been numerous PHNs regarding surgical mesh implanted transvaginally for the treatment of pelvic organ prolapse (“POP”) as well as stress urinary incontinence (“SUI”), conditions hundreds of thousands of women experience all across Pennsylvania and the rest of the United States.
Because so many women have been negatively affected by transvaginal mesh for the treatment of POP and SUI, it is important that anyone who has been implanted with a transvaginal mesh product should be aware of the FDA’s PHNs regarding the use of transvaginal mesh. Each of the FDA’s PHNs is described in further detail below.
October 21, 2008 FDA PHN About Surgical Mesh for the Treatment of POP and SUI
The first PHN regarding transvaginal mesh was released back in October of 2008 after both transvaginal mesh manufacturers as well as the FDA itself received more than 1,000 reports of complications associated with the use of transvaginal mesh for the treatment of POP and SUI. Such complications included, but were not limited to, erosion of the mesh, infection, pain, urinary problems, recurrence of POP and/or SUI, bowel perforation, bladder perforation, blood vessel perforation, and dyspareunia (pain during intercourse). Some of these complications have the potential to be permanent for some women.
July 13, 2011 FDA PHN – Serious Complications Associated with Transvaginal Mesh for POP
On July 13, 2011, the FDA strengthened its previous PHN on the use of transvaginal mesh, finding that there are serious complications that both physicians and patients must be aware of. This warning got the attention of a wider audience than the 2008 warning, and many people have become aware of just how dangerous transvaginal mesh can be. The FDA’s updated PHN documented that complications associated with transvaginal mesh for the treatment of POP were not rare, but rather more prevalent than previously thought.
March 27, 2013 FDA Notification About Surgical Mesh for Stress Urinary Incontinence (SUI)
Reported complications with the use of transvaginal mesh continued to increase after the 2011 warning, and the FDA further documented just how extensive the problem is with transvaginal mesh. The March 2013 FDA PHN alerted physicians and patients to what are called “mini-slings,” or “single-incision slings,” and how there is a lack of safety and efficacy associated with these types of slings for the treatment of SUI. The FDA indicated that there are no long-term studies to prove that these slings are both safe for women, and are effective for their intended use to treat SUI.
April 1, 2016 FDA Notification About Boston Scientific Corporation’s Transvaginal Mesh Products
The most recent FDA notification regarding transvaginal mesh was released in April of this year on allegations that one mesh manufacturer, Boston Scientific Corporation, used counterfeit transvaginal mesh material to make its products that were subsequently implanted into women. While these are simply allegations according to the FDA, the notification demonstrates that concerns about the use of transvaginal mesh continue to rise year after year, causing serious and debilitating injuries to women implanted with a transvaginal mesh product.
Contact Cordisco & Saile LLC Today to Schedule Your Free Consultation
Nobody deserves to suffer the consequences of transvaginal mesh that have left hundreds of thousands of women in constant pain and discomfort, both physically and mentally. If you or a loved one is experiencing complications and injuries associated with the placement of transvaginal mesh for pelvic organ prolapse or stress urinary incontinence, you should discuss the matter with a Pennsylvania Transvaginal Mesh Attorney as soon as possible. At Cordisco & Saile, LLC, we strive to represent our clients’ rights and interests to the best of our abilities. To learn more about what options may be available to you, contact the Pennsylvania Transvaginal Mesh Attorneys of Cordisco & Saile, LLC today by calling (215) 791-8911, or complete an online form on our Contact Us page to schedule your free consultation.