Tougher regulations have been slapped onto mesh surgical implants used for repairing pelvic organ prolapse (POP) in women, a condition that typically follows childbirth.
The U.S. Food and Drug Administration announced ont Monday that from being class II or moderate-risk, these medical devices will now be classified as class III or high-risk devices.
In a second order, it required manufacturers to submit a premarket approval application that vouches for the safety and effectiveness of these implants used transvaginally in patients.
The strengthened regulations followed an increased number of complaints and lawsuits associated with the use of these mesh implants.
Dr. William Maisel, chief scientist at the Center for Devices and Radiological Health of FDA, said these requirements will help address the issues associated with the said medical devices.
“We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures,” he said in an official statement.
POP Symptoms And Treatment
POP occurs when the bladder, uterus, or other reproductive organs slip out of place and bulge or prolapse into the vagina. This happens when the pelvic floor’s muscles and tissues become stretched or torn and can no longer support the organs.
Symptoms include low back pain, constipation, painful sexual intercourse, or urinary issues such as a chronic urge to urinate.
Plastic mesh is typically implanted during POP surgery to support the weakened pelvic wall. Surgical mesh has been used for repairing abdominal hernias since the 1950s. In the 70s, gynecologists started to use it for abdominal POP repair, and in the 90s, it began to be implanted for transvaginal POP repair.
Reported Problems And Complications
“[O]ver the past several years the FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair,” warned the FDA announcement, citing severe pelvic pain, bleeding and infection, and organ perforation as among the most common complications.
Over four years ago, the agency concluded that patients with vaginal mesh implants suffer more complications than those undergoing traditional surgery involving stitches. It estimated that around 10 percent of women experienced side effects from mesh, even sometimes going through multiple surgeries for implant repositioning or removal.
In 2011, an expert panel said more data is necessary to prove these devices’ safety. In 2012, the FDA issued orders for manufacturers to conduct post-market surveillance research on plastic mesh for transvaginal POP surgery.
The FDA’s 2014 draft orders first contained the changes announced Monday.
Thousands of patients also filed lawsuits against mesh makers, including Johnson & Johnson, Boston Scientific, and Endo International. Ireland-based firm Endo announced in 2014 an $830 million settlement of over 20,000 personal injury cases in court.
Like 90 percent of medical devices marketed and sold in the country, pelvic mesh was cleared before under a streamlined FDA review process considered similar to products that preceded them.
Mesh makers for transvaginal implant surgery have 30 months to submit a premarket approval application for devices already sold to the public. Makers of new devices need to submit an application before their products can be marketed.
In December last year, a team of gynecologists urged the FDA to revise its 2014 ban on using morcellator, a device designed to remove uterine fibroids. They pinpointed the agency’s reliance on flawed data analysis, leading to banning such mechanical devices that chop fibroids into tiny pieces during surgery.
Photo: Daniel Lobo | Flickr