(Reuters) - Boston Scientific Corp on Wednesday said it expects a setback of about $25 million to its full-year revenue due to the U.S. Food and Drugs Administration’s order to halt sales of its transvaginal surgical mesh products.
The FDA on Tuesday ordered Boston Scientific and Danish firm Coloplast A/S to immediately pull their mesh implants from the market as the companies did not demonstrate a reasonable assurance of safety and effectiveness of the devices.
Tens of thousands of lawsuits have been filed in recent years against mesh implant manufacturers claiming their products caused pain, perforations, urinary problems, bleeding and other injuries.
The company said it will continue to assess any potential additional impact to the business due to the FDA’s decision that applies to two of Boston Scientific’s products.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shinjini Ganguli