FDA Reclassifies Vaginal Mesh as High-Risk Device
By: CPR @ Jan 13, 2016
On January 4, 2015, the FDA reclassified vaginal mesh as a high-risk device. The original proposal to reclassify the mesh was announced in April of 2014, and was based on complaints that the surgical mesh had been linked to a variety of complications in female patients. In addition to the reclassification from a class II moderate-risk product to a class III high-risk product, the FDA’s decision also has implications for manufacturers of the surgical mesh.
Manufacturers Have 30 Months to Meet Standards
Not only did the FDA reclassify the transvaginal mesh has a high-risk product, but it also gave manufacturers of the mesh, which is used in transvaginal repair of pelvic organ prolapse in women and other surgeries, 30 months to prove that their products are safe for use. What’s more, these companies must submit a premarket approval (PMA) application before the transvaginal mesh can be used in surgeries, an act that they previously were not required to do. Prior to the new ruling by the FDA, companies merely were required to show that their mesh products were ‘substantially equivalent’ to those that were already on the market, according to an article in Medscape. The new standards will more highly scrutinize transvaginal mesh products, and will require that manufacturers fully detail and prove the mesh’s safety and effectiveness prior to gaining approval for use from the FDA. As a note, the FDA’s decision only apply to mesh that is used for transvaginal repair of pelvic organ prolapse, not to vaginal mesh that is used to treat urinary incontinence or abdominal repair of pelvic organ prolapse.
Why the Reclassification?
The FDA’s decision to reclassify vaginal mesh was based on a slew of complaints about the mesh—the FDA reports that is has received thousands of reports of adverse events—as well as multiple lawsuits against one of the most well-known vaginal mesh manufacturers: Johnson & Johnson. Vaginal mesh has been linked to severe pain, infection, uncomfortable and painful intercourse, urinary problems, perforation and puncture of organs, and internal bleeding. In fact, Johnson & Johnson has faced so many lawsuits for the above complaints that it has since ceased marketing transvaginal mesh products.
What Are My Legal Rights?
If you have suffered an adverse event as a direct result of the use of surgical mesh during a pelvic organ prolapse or other surgery, and if you have suffered harm due to the defective and dangerous nature of that mesh, you have legal rights. Like dozens of others before you, you can file a defective product suit against the makers of the transvaginal mesh for damages. The attorneys at the law firm of Cohen, Placitella & Roth, P.C. can help.
Contact a Defective Medical Device Attorney Now
The statute of limitations for filing a claim against the manufacturer of defective transvaginal mesh is quickly approaching. To ensure that your right to recover damages is protected, take action now by contacting the experienced Pennsylvania and New Jersey vaginal mesh attorneys at Cohen, Placitella & Roth, P.C. You can request your free case consultation online, or contact our offices now at (215) 567-3500.
Cohen, Placitella & Roth, PC (215) 567-3500