Boston Scientific To Incur $25 Mln Negative Impact To FY19 Revenue

(RTTNews) - Boston Scientific Corp. (BSX) revealed Wednesday in Form 8-K with the U.S. Securities and Exchange Commission that it anticipates about $25 million negative impact globally to 2019 full year revenue.

This was based on an April 16, 2019 order by the U.S. Food and Drug Administration (FDA) that all manufacturers of surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse stop selling and distributing their products in the U.S. immediately, stemming from the FDA's 2016 reclassification of these devices to class III (high risk) devices.

The FDA's order applies to two Boston Scientific product lines, Uphold LITE Vaginal Support System and Xenform Soft Tissue Repair Matrix.

Meanwhile, Boston Scientific continues to assess any potential additional impact to the business and will provide a further update on its conference call discussing financial results and business highlights for the first quarter ended March 31, 2019 on Wednesday, April 24, 2019.