|
Today, the U.S. Food and Drug Administration (FDA) is providing the final results of the postmarket surveillance (“522") study on Coloplast transvaginal mesh for pelvic organ prolapse (POP). The study results showed the mesh had similar outcomes to native tissue repair (repairs without the use of mesh) at 36 months. However, devices of this type for transvaginal POP mesh repair present potential additional risks compared to native tissue repair, including mesh exposure and erosion. Based on currently available information, the FDA has determined that the benefits do not outweigh the risks of surgical mesh placed transvaginally to treat POP.
Although these devices are no longer commercially available in the US, the FDA required the manufacturer to continue follow-up of previously implanted patients already enrolled in its postmarket surveillance study.
The FDA continues to take steps to support women's health and access to safe and effective medical devices. The FDA's efforts on urogynecologic surgical mesh have focused on identifying benefit-risk concerns related to some of these devices, and strengthening the FDA's regulatory oversight to protect patients, while enabling those who need these devices to benefit from them.
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
|
|
|
|
