The Food and Drug Administration Department of the US has given orders to the manufacturers of the pelvic mesh implants to fulfill new data requirements, with a view to strengthening the safety measures for the repair pelvic organ prolapse (POP). The devices are inserted inside via vagina, and the treatment is recommended when the pelvic floor’s tissue and muscles torn, become weak or too stretched to support the pelvic organs leading to prolapsed vagina.
Thousands of patients have complained about the complications such as urinary problems, organ perforation, infection and bleeding caused due to mesh implants for the transvaginal POP repair owing to which the FDA decided to come up with additional safety measure requirements for the process. In some women, the complications have been so severe that they had to undergo multiple surgeries to place the mesh in the right position or to remove it.
The two orders from FDA apply to the manufacturers of the mesh implants and also to the public. Women advised to undergo surgical mesh will have to fulfill the new data requirement if they want to repair pelvic organ prolapsed via either vagina or transvaginally. Thus, the new implant devices will have to undergo federal scrutiny so that they do not cause serious problems.
FDA to Classify Medical Devices
According to the new order from FDA, these medical devices until now were categorized under class II that include devices with moderate risk. However, the new order from FDA has shifted it under class III which lists high-risk devices. Another rule makes it mandatory for the mesh implant makers to furnish a premarket approval (PMA) application supporting the effectiveness and safety of the device.
Deputy Director of science and chief scientist for Devices and Radiological Health at FDA, William Maisel, M.D., and M.P.H said that the new clinical requirements would underline the greater risks that are caused due to the surgical mesh POP repair. He further said that his department would monitor how the device fares after months and years of surgery by adopting continuous postmarket surveillance measures.