Medical device recall of Ethicon Physiomesh™ Flexible Composite Mesh

Johnson & Johnson Pte Ltd would like to inform healthcare professionals of a voluntary recall of all Ethicon Physiomesh™ Flexible Composite Mesh (“Ethicon Physiomesh™ Composite Mesh”). An analysis conducted of unpublished data from two large independent hernia registries found that the recurrence and reoperation rates after laparoscopic ventral hernia repair using Ethicon Physiomesh™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries. Healthcare professionals are advised to stop using all Ethicon Physiomesh™ Composite Mesh products. For patients who have already been treated using the affected products, they should continue to be monitored in the usual manner and for symptoms of hernia recurrence. Please refer to the letter for details. 

 
 
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

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). HPP is 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: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

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

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