Synovis Peri-Guard Repair Patch and Supple Peri-Guard Repair Patch - removal of the indications for abdominal wall defect and hernia repair

A Dear Healthcare Professional Letter has been issued by Baxter Healthcare (Asia) Pte Ltd to inform healthcare professionals of a removal of the indications for abdominal wall defect and hernia (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical) repair from the Instruction for Use (IFU) for the Synovis Peri-Guard Repair Patch and Supple Peri-Guard Repair Patch. These devices are now indicated for use as prostheses for pericardial closure and soft tissue deficiencies which include defects of the thoracic wall, and intracardiac and great vessel repair. This change in indication was not driven by any known safety concerns. However, there is a lack of clinical data supporting the safety and effectiveness of the Synovis Peri-Guard Repair Patch and Supple Peri-Guard Repair Patch for abdominal wall and hernia defect repair. Healthcare professionals are advised to take note of the change in indications for these devices. Please refer to the letter for details.

Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

29 Apr 2024

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on 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://www.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 'Restricted Content' and log in via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’.

Step 4: Click on the Drug Alert tab to view the DHCPLs.