Boston Scientific Ordered to Halt Sale of Mesh Targeted in Suits Copyright Boston Scientific, Inc.

Boston Scientific Ordered to Halt Sale of Mesh Targeted in Suits

The FDA has determined that Boston Scientific has not demonstrated a "reasonable assurance of safety and effectiveness for these devices.”

U.S. health regulators ordered two medical device companies to stop selling surgical mesh used in pelvic repair surgeries after saying there isn’t enough evidence that the product embroiled in thousands of lawsuits is safe or effective.

The Food and Drug Administration told Boston Scientific Corp. and the Danish company Coloplast A/S “to stop selling and distributing their products in the U.S. immediately.” They were the last two companies selling surgical mesh for use during minimally invasive repair of pelvic organ prolapse, a common condition in women that develops when the muscles holding in the bladder and uterus weaken and the organs start to protrude from the vagina.

Vaginal mesh, which helps hold in the organs, was once made by 31 companies including Johnson & Johnson, C. R. Bard and Endo International Plc. The mesh was clouded by safety complaints after doctors started implanting it through the vagina in 2002, with complications including pain, infection and even death on rare occasions. The FDA recategorized mesh as a high-risk device in 2016 and required the companies to prove its benefits in order to keep the product on the market.

“The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices,” the agency said in a statement.

Vaginal mesh generates about $25 million in annual sales for Boston Scientific, according to Larry Biegelsen, an analyst at Wells Fargo & Co., who said the impact should be manageable. Vijay Kumar, an analyst at Evercore ISI, said the setback could lead Boston Scientific to lower its 2019 revenue estimates.

Coloplast has settled the lawsuits brought against it by women who said they were harmed by the devices. Boston Scientific has set aside more than $900 million for legal liabilities, with most of it tied to mesh lawsuits.

The companies will have 10 days to submit their plans for withdrawing their devices, the agency said.

Boston Scientific, based in Marlborough, Mass. decried the decision and said it would work with the agency to determine the company’s next steps. “We are deeply disappointed by the FDA’s decision,” said Kelly Leadem, a company spokeswoman. “The inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives,” she said.

Vaginal mesh accounts for about 0.2% of group revenue for Humlebaek, Denmark-based Coloplast, said company spokeswoman Lina Danstrup, who declined to comment further. The company generated $2.6 billion in sales last year.

While some mesh makers -- like Coloplast -- have settled all their cases, Boston Scientific still faces about 18,000 suits over the controversial implants. Most of those cases are in settlement negotiations, company officials said in a February filing with the U.S. Securities and Exchange Commission.

Other device makers, such as J&J, still face more than 34,000 claims their mesh devices damaged women’s organs and left them in severe pain., according to a February SEC filing. Unlike Boston Scientific and Endo, J&J hasn’t announced a settlement program. Instead, the device maker is resolving suits on a case-by-case basis.

By Michelle Fay Cortez and Jef Feeley

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