The Belgian competent authority FAMHP (Federal Agency for Medicines and Health Products) informed the BfArM about possible complications regarding the surgical mesh implant Rebound HRD / HRD-V. The implant by the manufacturer ARB Medical LLC (USA) is intended for the treatment of abdominal wall hernias. Fractures of a Nitinol (nickel titanium alloy) supporting ring component may lead to in part severe complications.

In October 2018 the manufacturer has recalled remaining products in the European market and given aftercare advice (please find the field safety notice attached). At that time, BfArM had no indication of a product distribution in Germany. As of today, no incident reports or other information were sent to the BfArM to indicate use of the devices in the German marked.
Due to new information, an indirect route of distribution of the products in Germany can no longer be ruled out. We therefore decided, as a precautionary measure, to provide this additional information on the issue. In the meantime, to the knowledge of BfArM, the US manufacturer has shut down its operations. The authorized representative at the time of distribution was Medpace Medical Device BV in the Netherlands. It is likely that the products have been distributed by the manufacturer Minnesota Medical Development Inc. (former name of the above manufacturer) and authorized representative MediTech Medical Development, Inc. (most likely the former name of the authorized representative), too.

At the current state of information, the fracture of the ring component may lead to in part severe complications (mostly pain). These may then necessitate the explantation of the product. In a single reported case the ring fracture resulted in bowel perforation.

For implanted patients BfArM therefore recommends:

• to consider regular follow-up checks even without symptoms

  and

• to seek immediate medical treatment if any symptoms such as pain, nausea, vomiting, fever, diarrhea and / or constipation should occur.

Physicians who are aware of patients implanted with the device are recommended to conduct appropriate aftercare and patient information.

Finally, BfArM would like to emphasize the reporting obligation of incidents in Germany as per German Ordinance on the Medical Devices Safety Plan (MPSV).

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telephone: +49 (0)228 99 307 3202 (Non-active medical devices)
Facsimile: +49 (0)228 99 307 5300
E-Mail: md-vigilance@bfarm.de