In a stunning move that sent ripples through the two manufacturers left making mesh devices, the US Food and Drug Administration put a stop to sales of pelvic meshes by Boston Scientific and Coloplast in the country. The agency cited a lack of proof that meshes are safe over the long term as their reasoning, as well as an increase in reports of “adverse events” tied to the devices.
Designed and marketed as a treatment option for women suffering from pelvic floor collapse, the condition can cause internal organs to slip out of place and cause pain, constipation, and issues with urination. Prior treatments had included invasive surgical techniques, however the mesh was supposed to be implanted as a way of supporting those organs, putting them back in place, and providing relief for symptoms.
It didn’t take long for the FDA to start receiving reports about a multitude of horrific injuries and adverse events after the devices were released, and the number of these reports of harm and injury would rise into the tens of thousands. By 2016, pelvic and transvaginal meshes would be classified as “high-risk” devices by the FDA as the complaints continued to flood the agency.
By 2018, over 100,000 gynecological mesh lawsuits were waiting to be heard in courtrooms around the country as devices continued to fail in disastrous ways including migration, organ perforation, breakage, and subsequent unbearable pain, bleeding, and other issues.
In an incredible piece of investigative reporting, 60 Minutes learned last year that many of the devices’ failures could be tied to a Boston Scientific plot to use inferior Chinese materials in the production of its mesh devices. Rebuffed by its primary materials supplier because of concerns over the implications of long-term use of the material Marlex in the human body, Boston Scientific would eventually move to import tons of counterfeit Chinese Marlex into the country and disguise the shipments so they would clear customs. During their investigation, CBS purchased 15 mesh kits produced by Boston Scientific and had them tested by a plastics lab. Every kit came back as being made from counterfeit Chinese plastic and not genuine Marlex.
In response to the FDA’s decision, Boston Scientific issued a statement noting its disappointment in the move and that “patient safety is always [the corporation’s] highest priority.”