World News: 08:59 GMT Wednesday 17th April 2019. [Coloplast A/S via Globe Newswire via SPi World News]
Coloplast was informed yesterday by the FDA that the PMA for Restorelle DirectFix Anterior is not approved and the company must cease marketing and distribution immediately.
As a result, FDA regulations require that all anterior transvaginal synthetic mesh products, including Coloplast’s Restorelle DirectFix Anterior device, can no longer be commercialized in the U.S., effective immediately. Coloplast will work with the FDA and other relevant authorities to ensure the orderly removal of these devices from customer inventories.
In accordance with the FDA guidance, Coloplast recommends that women who have received transvaginal mesh for the surgical repair of pelvic organ prolapse should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms. However, any patient with questions or concerns should speak to her healthcare provider. Please refer to the full statement on the .
Coloplast is disappointed by the FDA decision to remove surgical transvaginal mesh as a treatment option for women suffering from pelvic organ prolapse. Coloplast has been committed to working with the FDA on the 522 clinical studies to document the long-term efficacy and safety of the products.
Restorelle DirectFix Anterior accounts for approximalty 0,2% of group revenues, and there for the financial impact is immaterial and does not impact our financial guidance.
Coloplast has alternative solutions for the same type of products including tissue products as well as alternative procedures for pelvic organ prolapse. The FDA’s decision is limited to mesh for the transvaginal repair of pelvic organ prolapse and does not extend to mesh used to treat stress urinary incontinence.
Ellen BjurgertVice President, Investor Relations Tel. +45 4911 1800 / 4911 3376 E-mail firstname.lastname@example.org
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This announcement is available in a Danish and an English-language version. In the event of discrepancies, the Danish version shall prevail.
The Coloplast logo is a registered trademark of Coloplast A/S. © 2019-04 All rights reserved. Coloplast A/S, 3050 Humlebæk, Denmark.
Coloplast develops products and services that make life easier for people with very personal and private medical conditions. Working closely with the people who use our products, we create solutions that are sensitive to their special needs. We call this intimate healthcare.
Our business includes Ostomy Care, Interventional Urology, Continence Care and Wound and Skin Care. We operate globally and employ about 12,000 people.
Globe Newswire: 08:59 GMT Wednesday 17th April 2019
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