Events

Safety Alert for Surgical Meshes for Hernia Repair

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Johnson & Johnson International || Johnson & Johnson Medical Gmbh.

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
  • Event ID
    R1605-224
  • Event Number
    2011DM-0007247
  • Date
    2016-05-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=139
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer has initiated the withdrawal of the referenced device after an analysis performed at the recurrence / reoperation rates (respectively) after laparoscopic ventral hernia repair using the device, since they were higher than the average rates of the comparable group of meshes between patients within the the records, leading to adverse events on patients.

Device

Surgical Meshes for Hernia Repair
  • Model / Serial
    PHYSIOMESH Flexible Composite Mesh - PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, || PHY2030R, PHY2535V, PHY3035R and PHY3050R, all || lots.
  • Product Description
    PHYSIOMESH is indicated in the repair of hernias and other deficiencies of the fascia that require the addition of a reinforcing material or bridge to obtain the desired surgical result.
  • Manufacturer
    Johnson & Johnson International || Johnson & Johnson Medical Gmbh

Manufacturer

Johnson & Johnson International || Johnson & Johnson Medical Gmbh