Setback to Boston Scientific: Over Rs 173 crore hit to 2019 revenue from mesh withdrawal
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 Corp’s products.
New Delhi: 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.
Medical Dialogues had recently reported that the U.S. Food and Drug Administration(USFDA) had ordered makers of transvaginal surgical mesh implants to immediately stop their sale and distribution in the United States, the latest action by the agency to tackle safety issues related to the devices.
The FDA said Boston Scientific Corp and Coloplast A/S did not demonstrate a reasonable assurance of safety and effectiveness of these devices in their premarket applications. The companies will have 10 days to submit their plan to withdraw these products from the market.
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.