Scotland’s Health Secretary, Alex Neil, announced that he will seek a suspension of surgical mesh procedures in the country pending the completion of an inquiry into the safety of surgical mesh implants used to treat pelvic organ prolapse and stress urinary incontinence. According to the BBC, Neil took action in response to a petition circulated by “Hear Our Voices,” a group made up of women who were allegedly injured by the devices.
The new initiative was announced by Neil as he gave testimony to the Scottish Parliament’s Public Petitions Committee. “No women should have to go through the hell these women have been through,” he said.
The health secretary’s request for a suspension of pelvic mesh procedures in Scotland comes two weeks after members of “Hear Our Voices” appeared before the same committee to testify about their experience with vaginal mesh complications.
“We can’t change what happened to us but it’s not too late to make the changes we believe will protect others from future injury saving them and their families from pain, frustration and helplessness and possible disability,” Elaine Holmes told the Committee on June 3rd.
According to Holmes, her pelvic mesh injuries include chronic pain so severe that she often requires the use of a wheelchair.
According to the BBC report, more than 1,500 Scottish women undergo treatment with transvaginal mesh every year.
In the U.S., more than 50,000 women have filed lawsuit claims over complications they allegedly sustained from the devices. Plaintiffs filing these complaints allege that the products were never tested adequately, and that their manufacturers failed to provide appropriate warnings about their risks. The majority of pelvic mesh cases are pending in several consolidated litigation underway in West Virginia federal court, while thousands of others have been filed in state courts around the country.
As is the case in Scotland, mesh implant problems have also resulted in regulatory changes in the U.S. The Food & Drug Administration (FDA) has proposed that surgical mesh implants used to treat prolapse be reclassified as high-risk medical devices. This would make the devices ineligible for the FDA’s 510(k) clearance process, which allowed such products to come to market without human clinical trials. The reclassification would require companies that market mesh for prolapse repair to conduct studies of their products if they want to continue selling them.