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    • Setback to Boston...

    Setback to Boston Scientific: Over Rs 173 crore hit to 2019 revenue from mesh withdrawal

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-04-19T09:30:13+05:30  |  Updated On 19 April 2019 9:30 AM IST
    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.


    Also Read: USFDA bans sale of Transvaginal Surgical Mesh citing safety concerns


    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.


    Read Also: TAVR: Edward Lifesciences pays Boston Scientific $180 million to end patent dispute

    bladderbleedingbleeding vaginaBostonBoston ScientificBoston Scientific CorpBoston Scientific productsclass 3 meshColoplastColoplast ASCR BardDanish firm ColoplastFDAinjuriesJnJmesh withdrawalpainpelvic organpelvic organ prolapseperforationsrectumrevenuesurgical meshTransvaginal meshtransvaginal surgical meshU S Food and Drugs AdministrationUnited Statesurinary problemsUSFDAuterusvaginavaginal
    Source : With inputs

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    Medical Dialogues Bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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