Women with mesh implants are experiencing more problems than those who have a traditional surgery to repair prolapse.
The United States Food and Drug Administration (FDA) has said that pelvic mesh devices, used to repair pelvic organ prolapse (POP) in women, will now be considered a class III, high-risk device, and with the new classification, will be under even more federal scrutiny, according to CBS News.
POP, a condition that often develops in women after experiencing childbirth, occurs when the bladder or the reproductive organs slip out of place in the body, and usually results in pain, constipation and urinary issues.
Pelvic mesh is often a plastic mesh that is inserted through the vagina, with a small incision, and supports the pelvic wall and the organs when a patient has suffered from prolapse. It has been reported that some 200,000 operations are being done each year, and that as many as half of all women may experience prolapse within their lifetime.
The change in classification by the FDA comes about after many cases of pain, bleeding and infection among women who had the devices implanted, and the agency says that more women with the devices are experiencing difficulties than women who undergo a more traditional surgery to repair the condition.
The devices were previously considered “moderate-risk” by the FDA, with a corresponding class II warning. The new classification also means the manufacturers of the products will have to submit a pre-market approval application, that will provide information as to the safety and effectiveness of the devices.
The article continued by saying tens of thousands of lawsuits have been filed against the manufacturers of mesh devices, and that in 2014, one maker based in Ireland, agreed to pay $830 million to settle the more than 20,000 personal injury lawsuits facing the company.
Mesh implants are not the only options for women facing this condition. In addition to the aforementioned traditional surgery, there are exercise programs and other non-invasive treatments available to some with the condition.
The FDA has recommended that women make themselves aware of all the options available before making the decision to have the mesh implants, and to be sure to discuss any and all treatment options with your surgeon, both surgical and non-surgical.