April 17, 2019

Boston Scientific anticipates $25M hit after FDA pulls women's health products

Photo | TMS Aerial Solutions
Boston Scientific's Marlborough headquarters

Boston Scientific said Wednesday is forecasting a $25 million hit to its 2019 revenue after the U.S. Food & Drug Administration yanked two of its product lines from the market.

The Marlborough medical device manufacturing company, which recorded revenues of $9.8 billion in 2018, publicly announced the anticipated financial hit in a U.S. Securities & Exchange Commission filing.

The products are surgical mesh products designed for the transvaginal repair of pelvic organ prolapse and have been the subject of scrutiny in the press and courts, with thousands of lawsuits filed against the company due to pain and discomfort caused by the devices.

Sales of the two systems, the Uphold LITE vaginal Support System and Xenform Soft Tissue Repair Matrix were halted by the FDA on Tuesday after the agency determined the products did not meet its safety and effective standards.

In 2016, the FDA reclassified the products as high risk, requiring premarket approval for the devices to stay on the market.

Boston Scientific and Denmark-based Coloplast -- which sold a similar device -- have 10 days from Tuesday to submit a plan to withdraw the products from the market.

The company's stock price has taken a hit, falling from a Tuesday open of $38.05 to $35.52 around 11:30 a.m. Wednesday, a 7% drop.

On Tuesday, Boston Scientific released a statement, saying the inaccessibility of the products will severely limit treatment options for 50% of women in the U.S. suffering from pelvic organ prolapse.

"Patient safety is always our highest priority, and we will work closely with the agency to understand its direction and determine next steps," the company said.


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