FDA Bans Transvaginal Mesh Products for Pelvic Organ Prolapse
In This Article
- Safety concerns and poor outcomes from the placement of transvaginal mesh led to the sales ban
- While some physicians lamented that they would have fewer options to treating pelvic organ prolapse (POP), others applauded the ban, as mesh placement for POP leads to complications too often
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The U.S. Food and Drug Administration (FDA) has banned the sale of transvaginal mesh for pelvic organ prolapse (POP). The ruling is based on concerns about the safety and effectiveness of the mesh for women receiving treatment for POP.
Before the ban on mesh sales, many companies had already pulled their transvaginal mesh products off shelves. The FDA ruling thus ordered remaining manufacturers still selling mesh products to swiftly present a plan to discontinue sales.
Elise De, MD, urologist at Massachusetts General Hospital, told Medscape that even though transvaginal mesh is not needed in about 90% of cases, it is a good tool for surgeons to have in rare cases.
Dr. De explains that complications from transvaginal mesh made her less excited about implanting the product in patients with POP. She said that when the product was introduced, it was marketed as a way to expand the repertoire of surgeons who felt comfortable performing pelvic reconstruction by offering them an easier way to do it. This approach meant that safe products ended up in the hands of people who may not have been experienced enough to use them.
Human cadaveric products are an alternative to transvaginal mesh, said Dr. De, although there is a lack of long-term data on those products. Other than biologic products, however, there is a lack of new, comparable alternatives.
Given poor outcomes from transvaginal mesh, the official statement from the FDA advised women who were planning to have mesh placed transvaginally to discuss other treatment options with their doctors. The FDA also advised women who have had mesh implanted transvaginally with no complications to leave the mesh in place.
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