Events

Safety Alert for PHYSIOMESH Flexible Composite Mesh

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Ethicon.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-05-31
  • Event Date Posted
    2016-05-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160531c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: ethicon physiomesh flexible composite mesh medical device manufacturer, ethicon, has issued a medical device safety alert concerning its physiomesh flexible composite mesh [all product codes]. the manufacturer has initiated a worldwide medical device removal of ethicon physiomesh flexible composite mesh (for laparoscopic use). the manufacturer is removing the product following an analysis conducted at the request of the ethicon medical safety team of unpublished data from two large independent hernia registries (herniamed german registry and danish hernia database-dhdb). the recurrence/ reoperation rates (respectively) after laparoscopic ventral hernia repair using ethicon physiomesh flexible composite mesh were higher than the average rates of the comparator set of meshes among patients in these registries. based on the currently available data, the manufacturer believes that the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but the manufacturer have not been able to fully characterize these factors. consequently, the manufacturer has not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to remove ethicon physiomesh composite mesh from the global market. health care practitioners that have treated patients using ethicon physiomesh composite mesh are advised to follow those patients in the usual manner. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 may 2016.

Device

PHYSIOMESH Flexible Composite Mesh
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ethicon PHYSIOMESH Flexible Composite Mesh
  • Manufacturer
    Ethicon

Manufacturer

Ethicon