On April 16, 2019, the U.S. Food and Drug Administration (FDA) ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to immediately stop selling and distributing their products in the United States. The manufacturers, Boston Scientific and Coloplast, have been marketing three surgical mesh products for transvaginal repair of POP.
The FDA has determined that Boston Scientific and Coloplast “have not demonstrated a reasonable assurance of safety and effectiveness for these devices,” which is the premarket review standard that now applies to them since the FDA reclassified them in class III (high risk) in 2016. As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of premarket approval (PMA) applications, the FDA’s most stringent device review pathway, in order to continue marketing their devices in the United States. Boston Scientific and Coloplast have 10 days to submit their plan to withdraw these products from the market.
In reviewing the PMAs submitted by Boston Scientific and Coloplast, the FDA determined that they failed to provide an adequate assessment of the long-term safety of these devices and failed to demonstrate an acceptable long-term benefit of these devices compared to transvaginal surgical tissue repair without the use of mesh (native tissue repair). Since the FDA has not received sufficient evidence to assure that the probable benefits of these devices outweigh their probable risks, the FDA concluded that these products do not have a reasonable assurance of safety and effectiveness.
In announcing te FDA’s action, the Director of the FDA’s Center for Devices and Radiological Health stated, “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term. Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
Even though the mesh devices can no longer be used in patients moving forward, Boston Scientific and Coloplast are required to continue follow-up of the subjects already enrolled in their 522 studies.
Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias. In the 1970s, gynecologists began implanting surgical mesh for abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device for transvaginal repair of POP was cleared for use as a class II moderate-risk device.
About 1 in 8 women has surgery to repair POP over her lifetime, and a subset of these surgeries are completed transvaginally with the use of surgical mesh. However, the percentage of women undergoing transvaginal POP mesh procedures has decreased in recent years after the FDA began issuing warnings about the risks associated with using transvaginal mesh used for POP repair.
The FDA advises that women who have had transvaginal mesh placed for the surgical repair of POP should continue with their annual and other routine check-ups and follow-up care, and that there is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms. The FDA recommends that patients should notify their health care professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, and that they should also let their health care professional know if they have surgical mesh, especially if they plan to have another surgery or other medical procedures.
If you or a family member were implanted with vaginal mesh or other surgical mesh and suffered complications, injuries, or chronic pain afterwards, you should find a mesh claim lawyer in your U.S. state who may investigate your vaginal mesh claim for you and represent you in a claim against the manufacturer, distributor, and/or supplier of the vaginal mesh, if appropriate.
Visit our website or call us toll-free in the United States at 800-295-3959 to find mesh claim attorneys who may assist you.
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