Physiomesh Hernia Mesh Recall Lawyer
After hernia registries in Denmark and Germany reported high rates of hernia recurrence in patients implanted with Ethicon Physiomesh hernia mesh, a global recall was issued for this device by Ethicon’s parent company, Johnson & Johnson. Patients who suffer hernia recurrence due to defective Physiomesh may be subjected to unnecessary pain and suffering and may also be exposed to greater risks from subsequent surgeries to repair hernias.
Our personal injury lawyers are currently investigating Physiomesh hernia mesh lawsuits on behalf of patients injured by this allegedly defective medical device, as these individuals could be entitled to significant compensation for their damages.
What is Physiomesh Used For?
Physiomesh is used to repair ventral hernias during laparoscopic surgery. A ventral hernia usually occurs where a previous surgical incision has weakened a part of the abdomen, allowing internal organs to bulge out through a hole.
Physiomesh is a woven and laminated hernia patch made from flexible and bio-compatible plastic threads. During hernia repair, a surgeon will gently push abdominal organs back into place, then stitch a Physiomesh hernia patch over the opening to strengthen the abdominal wall and prevent hernia recurrence.
Use of a mesh patch such as the Physiomesh Flexible Composite Mesh to repair a ventral hernia that is too big to be closed with stitches is a common treatment, and up to 150,000 of these procedures are performed annually in the United States.
Recall of Ethicon Physiomesh
In May 2016, Johnson & Johnson announced a voluntary global recall of Ethicon Physiomesh Flexible Composite Mesh. According to the Urgent Field Safety Notice issued to operating room supervisors, materials management personnel, and chiefs of surgery around the world, the recall was prompted by the release of unpublished data requested by the Ethicon Medical Safety Team from two large independent hernia registries, the Herniamed German Registry and the Danish Hernia Database (DHDB). Both of these registries reported higher-than-average rates of recurrence or reoperation in patients who underwent laparoscopic ventral hernia repair with the Ethicon Physiomesh.
Ethicon reports that there may be a number of factors contributing to high rates of hernia recurrence after implantation with Physiomesh hernia mesh. Product characteristics, operative factors, and patient factors may all play a role. As Ethicon has been unable to determine which factor or factors may be causing the problems and issue corresponding instructions to surgeons to reduce adverse events. Consequently, the recall notice states, “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.”
All products in the Ethicon Physiomesh Composite Mesh line have been recalled. This includes the following models:
The recalled Physiomesh is made in a variety of shapes, including oval, rectangle, and square. Other Ethicon products are not impacted by this recall, nor is the Ethicon Physiomesh Open Flexible Composite Mesh product. In the Urgent Field Safety Notice, Johnson & Johnson recommends several alternative Ethicon products for ventral hernia repair.
Complications after Physiomesh Failure
Symptoms of Physiomesh side effects or a hernia recurrence may include:
- Intestinal blockage
- Physiomesh migration
- Adhesions (scar tissue causing organs to join together)
- Physiomesh contraction
If a patient experiences ventral hernia recurrence (or re-opening) after implantation with defective hernia mesh, the only way to repair it is with another surgical procedure. With each subsequent attempt to repair a hernia which has recurred, success becomes less likely. There are general risks associated with every surgical procedure, and since ventral hernias occur after abdominal surgery, it is possible that new hernias will form at incision sites.
Contact a Dangerous Medical Device Lawyer
Ethicon Physiomesh hernia repair mesh was approved in 2010 through the FDA’s controversial 510 (k) process, which allows for fast-track approval of devices if they are “substantially equivalent” to devices already on the market. This means that Ethicon may have missed an opportunity to identify potential defects through clinical trials, which could have spared the suffering of many patients.
If you or someone you love has suffered complications or hernia recurrence after implantation with defective hernia repair mesh, you may be entitled to compensation for pain and anguish, medical expenses, lost wages, and other damages. To learn more, please contact a Physiomesh recall lawyer for a free legal consultation.