The FDA ordered Boston Scientific and Coloplast to cease surgical mesh sales, saying the companies didn't demonstrate "a reasonable assurance of safety and effectiveness" for the devices, CNBC reports.
Three insights:
1. The companies were given 10 days to submit plans for withdrawing the products from the market. The meshes are used in some pelvic procedures.
2. Boston Scientific is "deeply disappointed" by the FDA's decision and will work with the agency to "determine next steps," the company told CNBC. The company said ending sales will restrict treatment options for women suffering from pelvic organ prolapse.
3. Coloplast plans to comply with orders to stop selling surgical mesh products, which represent 0.2 percent of its total revenue.