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Health Sciences Authority
Dear Healthcare Professional Letters

Medical device withdrawal of Xenform™ Soft Tissue Repair Matrix, Uphold™ Lite with Capio SLIM Vaginal Support System, Polyform™ Synthetic Mesh and Pinnacle™ LITE Pelvic Floor Repair Kit, Posterior

Audiences

Healthcare professional

Product type

Medical devices

6 May 2019

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Boston Scientific Asia Pacific Pte Ltd would like to inform healthcare professionals of a worldwide withdrawal of the following products indicated for transvaginal placement of pelvic organ prolapse - Xenform™ Soft Tissue Repair Matrix; Uphold™ Lite with Capio SLIM Vaginal Support System; Polyform™ Synthetic Mesh; and Pinnacle™ LITE Pelvic Floor Repair Kit, Posterior. Only the Uphold™ Lite with Capio SLIM Vaginal Support System is currently registered in Singapore. This withdrawal follows the United States Food and Drug Administration (US FDA) decision to withdraw all surgical mesh indicated for transvaginal repair of pelvic organ prolapse in the US market due to insufficient clinical evidence available to assure that the benefits of these devices outweigh their probable risks. Healthcare professionals are advised to immediately discontinue the use of the affected products and return them to Boston Scientific. Patients who were implanted with the affected products are recommended for continued routine check-ups and follow-up care, with no need for additional action if they are satisfied with their surgery and are not having any complications or symptoms. Please refer to the letter for details.


Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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