06.05.2019
Withdrawal of products indicated for transvaginal placement of pelvic organ prolapse produced by Boston Scientific Corporation
Affected products
- Xenform Soft Tissue Repair Matrix
- Uphold Lite with Capio SLIM Vaginal Support System
- Polyform Synthetic Mesh
- Pinnacle LITE Pelvic Floor Repair Kit, Posterior
A list of the product codes concerned is contained in the appended letter from the manufacturer.
Manufacturer
Boston Scientific Corporation.
Reason for publication
Swissmedic was informed by the manufacturer regarding its decision to withdraw from inventory all products listed above which are indicated for the transvaginal repair of pelvic organ prolapse.
Patients who have had transvaginal mesh placed for the surgical repair of pelvic organ prolapse should continue with their annual, other routine check-ups, and follow-up care. There is no need to take any additional action if patients are satisfied with their surgery and are not having any complications or symptoms.
Swissmedic is publishing this decision because of the interest currently being shown by the media in the use of pelvic floor meshes and incontinence slings.
Notice for patients: If you have health concerns connected with your implants, please consult a healthcare professional.
Description of the risk
Unclear risk/benefit ratio of the products.
Recommended action
Swissmedic recommends to follow the manufacturer's instructions (see attached information letter from the manufacturer).
Contact
Swissmedic
Swiss Agency for Therapeutic Products
Medical Devices Division
Hallerstrasse 7
3012 Bern
Tel.: +41 58 462 02 23
Fax: +41 58 462 76 46
Internet: www.swissmedic.ch/md
E-mail: medical.devices@swissmedic.ch