What is Ethicon Physiomesh™?
Ethicon Physiomesh™ Flexible Composite Mesh is a trademarked surgical mesh product that was implanted by surgeons to repair hernias caused by tears or weaknesses in the abdominal wall. Ethicon, Inc., a subsidiary of Johnson & Johnson based in West Somerville New Jersey, manufactured the medical device. The company withdrew the product from the market after data suggested that patients who had the Physiomesh™ Flexible Composite Mesh implanted were more likely to experience complications that required follow-up surgeries.
If you have been injured through the use Physiomesh™ Flexible Composite Mesh in your hernia repair surgery, the law permits those who have been harmed by defective medical products to seek compensation for their injuries, including financial or economic loss, and for their pain and suffering.
Ken Stern and the attorneys of Stern Law, PLLC, take on faulty surgical mesh cases for injured patients and their families from across the United States. Defective medical device claims are complex cases that often require taking on large corporations. You need an attorney with the resources and determination to pursue these challenging cases. Stern Law has pursued justice on behalf of many people facing difficult situations similar to you and your loved ones.
Our legal representation is personalized and uniquely tailored to address the needs and concerns of each of our clients. Let Stern Law speak for you.
Physiomesh™ in Use Since 2010
Ethicon Physiomesh™ Flexible Composite Mesh is an implantable product made of plastic filaments that are woven into a mesh fabric. It is supposed to be compatible with the abdominal wall. Physiomesh™ Flexible Composite Mesh is one of a number of surgical mesh products used for hernia repairs. A hernia occurs when the intestine or other tissue squeezes through a hole or weak spot in the muscle or connective tissue. Hernias often develop in the wall of the abdomen. A hernia that develops in the abdominal wall is known as a ventral hernia. Hernia repairs are a common procedure.
Patients who develop hernias have a higher likelihood of developing another hernia. Since the 1980s, doctors have increasingly used surgical mesh to strengthen or reinforce the abdominal wall and reduce the chances that the patient will develop another hernia and require additional surgery. The majority of surgical mesh products are made of synthetic materials or animal tissue. Today, many hernia surgeries are done as laparoscopic procedures, using minor incisions, which provides for quicker recovery. Ethicon Physiomesh™ Flexible Composite Mesh is a sterile, low profile mesh made of knitted synthetic polypropylene. It was designed for laparoscopic procedures.
Physiomesh™ Flexible Composite Mesh was placed on the market in 2010 without a rigorous review by the Food and Drug Administration. The FDA may expedite approval of medical devices such as hernia mesh through a process known as “510(k) clearance.” This process allows a medical device manufacturer to claim that their product is substantially equivalent to a product already on the market.
Ethicon sought and obtained expedited FDA approval to put PHYSIOMESH™ Flexible Composite Mesh on the market. Ethicon said the product was substantially similar to products already on the market, and thereby bypassed providing more extensive proof of the product’s safety.
If you or a loved one underwent laparoscopic hernia surgery between 2010 and 2014, you may have received Ethicon PHYSIOMESH™ Flexible Composite Mesh as part of your hernia repair procedure. If you have developed complications or had to have follow-up operations because the mesh failed, you may have a valid claim for the injury you suffered as a result of a defective product. A hernia mesh lawyer at Stern Law can provide guidance to you.
What are Potential Complications of Physiomesh™ Flexible Composite Mesh?
Patients who have undergone hernia surgery and receive Physiomesh™ may experience a number of complications including severe abdominal pain, infections and swelling.
A potential complication associated with hernia operations using surgical mesh is mesh shrinkage or the mesh shifting inside the patient’s body, according to the Food and Drug Administration. Internal movement of hernia mesh can cause a bowel blockage or perforation of an organ as well as infections and other complications. Unfortunately, a number of surgical mesh products have been recalled because of serious injuries to patients and complications that caused patients to undergo additional surgeries.
In 2016, the Johnson & John subsidiary Ethicon, based in West Somerville, New Jersey, issued a notice voluntarily withdrawing Ethicon Physiomesh™ Composite Mesh product from the market. Note: the withdrawal does not include the similarly named Ethicon Physiomesh™ OPEN Flexible Composite Mesh or other hernia mesh products manufactured by Ethicon.
Ethicon said it was withdrawing the product after an analysis of unpublished data from a pair of hernia registries in Denmark and Germany. The review revealed an alarming discrepancy in rates of follow-up surgery between Ethicon Physiomesh™ Flexible Composite Mesh and other meshes used for similar hernia repairs. The analysis showed that patients who received the Ethicon Physiomesh™ Composite Mesh for laparoscopic hernia repair had higher than average rates of follow-up operations due to problems with the mesh, according to Ethicon’s Field Safety Notice.
Ethicon said that it believed that the higher rates of repeat operations were due to product characteristics as well as factors involving the operation and patients, but that it had not been able to further characterize them. Ethicon said it has been unable to issue further instructions to surgeons using the product to reduce the need for follow-up surgeries.
Do You Have a Physiomesh™ Injury Claim?
Stern Law can assist if you suspect a faulty surgical mesh product was the cause of your preventable injury or your loved one’s death after a hernia procedure. Our law firm can investigate the circumstances of your hernia repair injury and determine whether the harm was caused by defective Physiomesh™ Flexible Composite Mesh.
When preparing a hernia mesh product liability lawsuit, our attorneys gather evidence to establish that your injury was the result of a manufacturing defect and/or a design defect, that the product was unreasonably dangerous, or that the manufacturer failed to warn consumers adequately of known dangers associated with the product.
Evidence to support a product liability lawsuit might come from medical experts, published independent research about hernia mesh, FDA action (such as a recall), or a court-ordered release of the manufacturers’ documentation and internal records about the development and/or marketing of the product.
If a defective product has been widely used, it may have caused injuries to numerous people before it was a focus of safety concerns or withdrawn from use. Multiple product liability lawsuits may be filed against the manufacturer of the defective or unsafe product. This may lead to courts consolidating cases as class action lawsuits (combined because plaintiffs’ claims are similar) or as multi-district litigation, or MDL (combined according to geographic region.
Your attorney can discuss with you the advantages and disadvantages of taking part in a class action lawsuit and pursuing an independent product liability claim.
Stern Law will review your case and discuss with you whether you have a valid case and what your options are to move forward. Our objective is to help determine why and how you or your loved one was injured. If the injury was caused by a manufacturer’s negligence, we will be ready to help you pursue compensation for your losses.
Our pledge is to listen to you, work to answer your questions and concerns, and vigorously pursue the course of action that’s best for you.
Let Stern Law Protect Your Rights after a Hernia Mesh Injury
You may seek compensation for the harm you have suffered by filing a product liability claim against the manufacturer of defective Physiomesh™ Flexible Composite Mesh. You may be entitled to seek compensation for:
- Medical costs
- Lost wages
- Out-of-pocket expenses
- Emotional trauma
- Pain and suffering
You should keep in mind that product liability cases are time-consuming to investigate and prepare. Big pharmaceutical companies will put up a vigorous defense. It is important to approach a case with a clear expectation of what may lie ahead.
Stern Law works with a network of lawyers experienced in medical product liability, medical malpractice and personal injury cases. We investigate cases and move forward with a focus on addressing our clients’ concerns and advocating for their interests.
A product liability claim involving a hernia mesh injury starts with 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.
We have the experience and resources needed to pursue justice and to maximize your chances of receiving just compensation for the harm you have suffered. Let Stern Law stand up for you.
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