What Led to the Removal of Ethicon Physiomesh™ Hernia Mesh?

Johnson & Johnson and its subsidiary, Ethicon, Inc., a medical device manufacturer, withdrew Physiomesh™ Flexible Composite Mesh from the market based on the results of studies that showed unreasonably high rates of hernia recurrences and complications among patients who had the synthetic mesh implanted during hernia operations. If you or a loved one has experienced complications after receiving defective Physiomesh™ Flexible Composite Mesh as part of your hernia repair surgery, you may be entitled to seek compensation for your injuries, medical expenses, and financial losses associated with the injury.

Ken Stern and the legal team at Stern Law, PLLC, advocate for injured patients and their families throughout the United States who have been injured by Physiomesh™ complications. Hernia mesh injury lawsuits are complicated cases that require taking large corporations to court. You need a proven product liability attorney with the resources and determination to take on these challenging cases. We have a team of hernia mesh injury attorneys throughout the country who carefully investigate Physiomesh™ Flexible Composite Mesh claims and pursue lawsuits on behalf of those who have been harmed. Stern Law has pursued just compensation for many people just like you —people who were injured by a defective medical device.

Our Physiomesh injury attorneys offer personalized legal representation focused on pursuing the best resolution based on your individual needs. Let an experienced hernia mesh attorney at Stern Law offer trusted guidance to you and your family.

Analysis of Hernia Patient Data Prompts Removal of Physiomesh™

Ethicon, Inc. said its decision to withdraw Physiomesh™ Flexible Composite Mesh from the market was based on an analysis of unpublished data from two large, independent hernia registries in Germany and Denmark. Patient registries are repositories of information collected in a systematic way that allow for the tracking of long-term complications and recoveries of patients who underwent a procedure such as a hernia repair. The registries allow a comparison of evidence on the effectiveness of various treatments and prevalence of side effects involving comparable hernia mesh products.

The data on which Ethicon based its decision to withdraw Physiomesh™ from the market has not been published as a medical study. The Ethicon Medical Safety Team requested the data analysis, the company said.  According to Ethicon, the analysis showed patients who had Physiomesh™ Flexible Composite Mesh implanted during laparoscopic surgery had higher than average rates of complications and recurrence of hernias requiring additional surgeries compared to other hernia patients who received other mesh products.

Ethicon said there appeared to be multiple factors including product characteristics and patient factors involved in the higher rates of repeat hernia surgeries and complications. But Ethicon said that it could not fully characterize the factors or provide further guidance to doctors to reduce the recurrence rate of hernias. Therefore, Ethicon said it had decided to withdraw Physiomesh™ Flexible Composite Mesh (for laparoscopic use) from the worldwide market. While the data have not been published, it is fair to say it revealed some very significant safety concerns to prompt the company to remove Physiomesh™ from the market.

Urgent: Safety Notice Withdrawing Physiomesh™ Flexible Composite Mesh

Ethicon, Inc. issued an Urgent Field Safety Notice announcing the voluntary withdrawal of the product.  The scope of the device removal includes all product codes of Ethicon Physiomesh™ Composite Mesh.

The company said the device removal had been communicated to the Food and Drug Administration. The product withdrawal involves only the Ethicon Physiomesh™ Composite Mesh product line, which is used in laparoscopic surgery. It does not include the Ethicon Physiomesh™ Open Flexible Composite Mesh device or other products manufactured by Ethicon. Ethicon instructed doctors who have treated patients using Physiomesh Composite Mesh to continue to follow the patients.

Was Physiomesh™ Studied in Clinical Trials Before Being Put on the Market?

Ethicon, Inc., the manufacturer, received approval to put Physiomesh™ on the market through the FDA’s 510(K) program without clinical trials.

The FDA 510(k) regulatory clearance process allows products that are substantially equivalent to products already legally on the market to receive fast track approval. A product may be substantially equivalent if it has the same intended use and shares the same technological characteristics as a product on the market. The FDA relies on the information provided by the manufacturer in assessing whether a product is substantially equivalent. The 510(k) process is a far less stringent review process than going through premarket approval, which involves clinical trials and testing to determine whether a product is safe. The 510(k) process does not evaluate the safety of a medical device.

In applying for expedited review and approval, Ethicon, Inc. said Physiomesh™ was similar in technological characteristics to its Proceed mesh, which is used for repair of hernias and other weaknesses that require reinforcement or bridging material. Proceed surgical mesh had been on the market since 2006.  In 2010, Ethicon, Inc., sent out an urgent product recall of one lot of Proceed surgical mesh because of the potential for delamination of the product.

Unfortunately, the expedited approval of Physiomesh™ means it did not undergo the type of rigorous regulatory review that ideally all new medical products and devices should receive. The serious side effects and complications caused by Physiomesh™ gradually showed up as trends in the patient hernia registries after the hernia was put into wide use.

Has the FDA Studied Hernia Mesh Complications?

In 2014, the FDA posted a safety alert regarding patient reports of complications involving mesh used in hernia operations. The FDA said it had received reports of serious complications related to the use of hernia mesh. The alerts are intended to provide new safety information about medical products and may affect patient treatment.

The FDA’s safety alert said the complications include adverse reactions to the mesh, adhesions when the loops of the intestines stick to each other or the mesh, damage to other organs, and injury to nerves or blood vessels. Other complications include infection, abdominal pain and development of another hernia.

The FDA said it is important for patients to inform their surgeon if they have had an adverse reaction to materials such as polypropylene used in surgical mesh and to understand the benefits and risks of using hernia mesh.

The FDA said most of the complications involved products that had been recalled or were no longer on the market.

What Can You Do if You Have Had Complications from Hernia Repair Surgery?

You should contact an experienced hernia mesh injury attorney to discuss your legal options and whether you have a valid claim. You may have a right to claim compensation against Ethicon, Inc., and Johnson & Johnson for the harm you have suffered from defective Physiomesh™. You may be entitled to seek compensation for:

• Medical costs
• Lost wages
• Out-of-pocket expenses

• Emotional trauma
• Pain and suffering

You should understand that product liability cases are time-consuming to investigate and prepare. It is important to be represented by experienced medical product liability attorneys who have the resources to investigate these cases to conclusion.

Stern Law works with a national network of lawyers experienced in handling product liability cases. We focus first on addressing our clients’ concerns and advocating for their interests.

Take the important first step of scheduling a free and confidential evaluation of your legal options. If we believe that you have a valid claim, we will obtain your medical records and start investigating.

Stern Law has the determination and broad experience in product liability litigation to maximize your chances of receiving fair compensation for the harm you have suffered. Let Stern Law fight for you.