Frequently Asked Questions about Physiomesh™ Hernia Mesh Complications

Ethicon, Inc., a subsidiary of Johnson & Johnson, based in West Somerville, New Jersey, manufactures Physiomesh™.

The manufacturer, Ethicon, Inc., a subsidiary of Johnson & Johnson, notified hospitals in 2016 that it was removing the surgical mesh from the market because too many patients who had the mesh implanted were suffering complications and having to have repeat hernia surgeries. By 2016, Physiomesh™ Flexible Composite Mesh had been in use for approximately six years. Hernia repair is a common procedure. Many patients had had Physiomesh™ placed in their abdominal walls to reinforce them. Clear trends in rates of complications emerged in data reported to health registries in two countries, Germany and Denmark. A review of the data from the registries requested by Ethicon’s Product Safety Team showed patients who had Physiomesh™ Flexible Composite Mesh had higher than average rates of complications requiring repeat surgeries. Ethicon said there appeared to be multiple factors involved, but that it could not provide guidance to doctors to address the issue. Therefore, it was withdrawing the product from the market.

Yes, there are two Physiomesh™ products with similar names. That can be confusing to patients.  One is Physiomesh™ Flexible Composite Mesh (for laparoscopic use). It was designed for use in laparoscopic hernia repair surgeries in the abdominal wall. Ethicon, the manufacturer, voluntarily withdrew Physiomesh™ Flexible Composite Mesh (for laparoscopic use) from the market in May 2016.  The other product is Physiomesh™ OPEN Flexible Composite Mesh. The second product is used during more complicated, open hernia repair surgeries involving a large incision. The second product remains on the market and has not been withdrawn.

Physiomesh™ Flexible Composite Mesh was on the market and available for doctors to use in hernia repairs starting in 2010. Any patient who underwent laparoscopic surgery from 2010 to 2016 for a ventral wall hernia repair may have had Physiomesh™ implanted. Although the product has been withdrawn from use, many patients still have Physiomesh™ hernia mesh implanted in them. Patients who have had Physiomesh abdominal mesh implanted should be monitored by physicians for any problems. You should seek prompt medical care if you develop an infection, pain or discomfort. If you develop a complication involving the hernia mesh, you may need to undergo another surgery and have the mesh removed and another hernia repair made.

Yes. The use of abdominal mesh is supposed to reduce the recurrence of hernias. But contrary to its intended use, Physiomesh™ Composite Flexible Mesh has resulted in an increase in recurrence of hernias among patients, whose surgeries appeared initially successful.

Physiomesh Flexible Composite Mesh has multiple layers laminated together. The center layer is polypropylene and it is covered on both sides by polymer films that are designed to reduce inflammation and unwanted adhesions. Unfortunately, some patients have developed unwanted adhesions and complications. With some patients, Physiomesh™ has failed to stay in place and implant properly in the abdominal wall. Instead, it has moved inside the patient’s body and gotten attached to organs such as the bladder or a loop of the intestines. Patients who have experienced serious complications or reactions to Physiomesh™ may require additional surgery to remove the defective mesh and repair the hernia again.

As a start, you can ask your surgeon or the hospital where the procedure was performed for the name of the mesh product used during your hernia surgery. It is helpful to get the precise name. When our attorneys at Stern Law represent you in a product liability case, we will obtain your medical records and have them reviewed by independent medical experts and medical device specialists provide an opinion about whether faulty Physiomesh caused your complications.

Any patient or immediate family member of a patient who has been harmed by complications of a Physiomesh hernia repair patch may have a legal right to file a Physiomesh injury lawsuit against Ethicon, Inc., the manufacturer of the defective mesh product. As a patient, you have a right to expect that the medical devices you have implanted will work as intended and will not cause harm. If a product has a defect design, the manufacturer should be held accountable for harm caused the faulty product. One of our attorneys can discuss with you the possibility of a Physiomesh lawsuit.

At Stern Law, we are available to review the specific facts of your situation and offer our opinion of whether you have a case free of charge. We know that you are going through a difficult situation, may be out of work and don’t need more bills and expenses right now. Our attorneys will explain your legal options so that you can make a well-informed decision. If we agree to handle your Physiomesh injury claim, we will pursue the case on a contingent fee basis. As our client, you will not have any upfront costs and will not owe a legal fee unless we are successful in obtaining compensation for you through a settlement or jury award.

You would not be suing your doctor. Your doctor likely had no way of knowing the Physiomesh™ had a higher failure rate when he or she used it to repair your hernia. A Physiomesh product liability lawsuit would name the manufacturer of the defective hernia mesh, Ethicon, Inc. and its corporate parent, Johnson & Johnson. Your doctor would not be sued. A product liability lawsuit seeks to hold the manufacturer of an unsafe medical device or product liable for the harm caused.

If you or a member of your family suffered a serious complication as a result of defective hernia mesh, you may have to go through additional surgery and be out of work for long time, losing income as a result. You may have many unanticipated medical bills from the surgeon, anesthesiologist, hospital and pharmacy. The whole ordeal could be very costly and exceed the limits of your health insurance. You may be left with sizable medical debt that you should not have to pay when a defectively designed medical product caused the problem. If a member of your family suffered fatal complications from a defective medical device, no amount of compensation will be adequate to replace your loved one. But a settlement can provide some financial security for your family and relieve the financial stress you are experiencing. In our experience, a settlement also may help a family who has lost a loved one as a result of a defective product reach some sense of closure.

IF you have been injured by a defective medical device, the manufacturer may be held liable for your injuries. You may be entitled to seek compensation for:

• Medical costs
• Lost wages
• Out-of-pocket expenses
• Emotional trauma
• Pain and suffering

Our attorneys are available to discuss your specific legal questions. Contact Stern Law for a no-obligation consultation with a knowledgeable Physiomesh™ hernia injury attorney.