Summary
Boston Scientific Corporation (BSX) announced on April 16, 2019, that the U.S. Food and Drug Administration (FDA) has ordered an immediate halt to the sale and distribution of surgical mesh products for transvaginal repair of pelvic organ prolapse. This directive impacts two of Boston Scientific's product lines: the Uphold™ LITE Vaginal Support System and the Xenform™ Soft Tissue Repair Matrix. The company anticipates this regulatory action will result in a negative revenue impact of approximately $25 million for the full fiscal year 2019. Boston Scientific is continuing to evaluate the broader implications of this decision on its business and intends to provide further details during its first-quarter 2019 earnings conference call scheduled for April 24, 2019. Investors should monitor upcoming communications for a more comprehensive understanding of the financial and operational adjustments the company may undertake.
Key Highlights
- 1FDA mandates immediate cessation of sales and distribution for transvaginal surgical mesh used in pelvic organ prolapse repair.
- 2Boston Scientific's Uphold™ LITE Vaginal Support System and Xenform™ Soft Tissue Repair Matrix are directly affected by the FDA order.
- 3Anticipated negative revenue impact of approximately $25 million for the full fiscal year 2019.
- 4Company is actively assessing further potential business impacts.
- 5Additional updates on the situation and financial outlook to be provided on the Q1 2019 earnings call on April 24, 2019.
- 6The information is provided under Regulation FD Disclosure and is not deemed 'filed' for purposes of Section 18 of the Exchange Act.