Ethicon Physiomesh Flexible Composite Mesh

Hazard alert - higher rate of recurrence/reoperation

9 June 2016

Consumers and health professionals are advised that Johnson & Johnson Medical, in consultation with the TGA, is issuing a hazard alert for Ethicon Physiomesh Flexible Composite Mesh (for laparoscopic use). Johnson & Johnson Medical is also recalling all unused stock of these devices (all product codes and all lots).

Ethicon Physiomesh Flexible Composite Mesh is an implanted medical device that can be used in laparoscopic operations to repair ventral hernias and other fascial issues requiring a reinforcing or bridging material.

Analysis of unpublished data from two large independent overseas hernia registries (Germany and Denmark) has shown that laparoscopic ventral hernia repair using Ethicon Physiomesh Flexible Composite Mesh has a higher rate of recurrence/reoperation compared to the average rates of other similar products among patients in these registries.

The factors causing this increased rate cannot be fully determined at this time, but are believed to be multifactorial.

Based on this, a decision has been made to withdraw the device from the global market and provide what information is available to health professionals to assist in the management of affected patients.

Please note that this issue only affects Ethicon Physiomesh Flexible Composite Mesh (for laparoscopic use). It does not affect Ethicon Physiomesh Open Flexible Composite Mesh or other hernia or urogynaecological mesh products.

Information for consumers

If you have had laparoscopic surgery to treat a ventral hernia using a mesh and you experience any signs or symptoms of recurrence of the hernia, talk to your health professional. They may refer you to your surgeon or to the hospital where the surgery was undertaken.

If you have any other questions or concerns about this issue, talk to your health professional.

Information for all health professionals

If you are treating a patient who has had laparoscopic surgery to treat a ventral hernia using a mesh, be aware of this issue.

If the patient is experiencing any signs or symptoms of recurrence of the hernia, or if they have any questions or concerns about this issue, refer them to their surgeon or the hospital where the surgery was undertaken.

Information for hospitals and surgeons

Hospitals should inspect their stock and quarantine any unused Ethicon Physiomesh Flexible Composite Mesh (for laparoscopic use). Contact Johnson & Johnson Medical on 1800 252 191 (option 1) to arrange the return of any recalled devices.

Management of the patient remains at the discretion of the treating health professional and should be based on the individual circumstances of the patient.

If you have any questions or concerns about this issue, contact Johnson & Johnson Medical on 02 9815 3661.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.