Withdrawal of vaginal mesh

03 May 2019

Three types of vaginal mesh for surgical treatment of pelvic organ prolapse have been withdrawn in the USA after the FDA has assessed that the evidence of the products' efficacy and safety is insufficient. As a result, the products will no longer be available in Denmark.

Three types of vaginal mesh, so-called mesh implants, are now being removed from the US market. The vaginal mesh are used in surgical repair of pelvic organ prolapse, including vagina, bladder and uterus, to repair the patient's own tissue and support it. 

The specific products are:  Uphold LITE Vaginal Support System and Xenform Soft Tissue Repair System from Boston Scientific and Restorelle DirectFix Anterior from Coloplast.

As a result of the withdrawal of the authorisation to market the products in the USA, one of the manufacturers, Boston Scientific, has chosen also to cease marketing and withdraw the products in the rest of the world.

Consequently, the products will not be available in Denmark. The vaginal mesh from Coloplast has not been used on the Danish market.

Mesh is used restrictively in Danish patients

Boston Scientific and Coloplast have had their marketing authorisations for their vaginal mesh withdrawn by the FDA, after the FDA determined that the companies had not demonstrated reasonable assurance of safety and effectiveness for these products.

Vaginal mesh implants have been used in surgical treatment in Denmark when considered relevant based on a medical assessment of benefits and risks in the individual patient's case. In recent years, surgery has only been offered by highly-specialised departments at Aarhus University Hospital and Herlev Hospital.

Women who have received a vaginal mesh should continue with their annual routine check-ups and follow-up care. There is no need for patients to take additional action if they are satisfied with their surgery and are not having any complications or symptoms.

Boston Scientific has issued a field safety notice to customers and users.

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