Recalls & Settlement Information
Physiomesh is a type of mesh which is implanted during a surgical hernia repair. It is manufactured by Ethicon, a division of health products giant, Johnson & Johnson and has been used in hundreds of thousands of surgical procedures each year in the U.S.
Surgical mesh is classified as a medical device and can be made from natural, synthetic or composite materials. It is implanted through a surgical procedure and is intended to help stabilize weakened or damaged tissue that has resulted in a hernia. The Food and Drug Administration estimates that up to 90% of the 800,000 hernia repair procedures yearly, used surgical mesh. Ethicon is the leading manufacturer of hernia mesh with Physiomesh as the number one selling brand, which has made $ billions in revenue for the company.
Though the introduction of surgical mesh and its use in hernia repair is intended to increase success of the procedures, tens of thousands of patients have developed complications. Many of these patients have filed Physiomesh lawsuits against Ethicon and parent company Johnson & Johnson. Over 50,000 hernia mesh lawsuits are estimated to be pending in federal, state and local courts.
Plaintiffs who filed Physiomesh lawsuits seek compensation for their injuries including pain, infection, recurrence, organ damage and a need for revision or repair surgeries. Compensation in medical injury lawsuits often includes payment for medical costs, lost wages, pain and suffering and future medical costs. In some cases, plaintiffs receive punitive damages when it can be proven that the company knew a product was defective but continued to sell it anyway.
Ethicon has been accused of producing a defective medical device, failing to adequately test the product adequately, failing to adequately warn the public and medical community about the risks of Physiomesh and of putting profit ahead of safety.
Over 800,000 hernia repair procedures are performed in the U.S. each year. Since its introduction and starting in about 2000, an increasing number of these procedures have used surgical mesh to stabilize the muscle tissue or abdominal wall. The number one adverse event related to any hernia procedure is recurrence of the injury. Physiomesh and other hernia mesh products were intended to eliminate recurrence.
Unfortunately, hernia recurrence continues to occur and the use of Physiomesh may increase the chance for other complications which may be serious or even life-threatening.
Complications caused by Physiomesh may include:
- Bowel obstruction
- Pain which may be severe and long-lasting
- Mesh migration
- Organ perforation
- Abdominal tissue adhesion
Most studies have shown benefits in the use of Physiomesh or other surgical hernia mesh to help prevent recurrence, however most studies have not been long-term. A study conducted in 2016 showed that about one-third of patients who have received hernia mesh, may develop complications after a 5-year period. Though early complications may be reduced, they still occur, and the benefits may be off-set by long-term injuries.
Types of Hernia Mesh
The components or construction of Physiomesh and other hernia mesh products including another brand, C-QUR mesh by Atrium, may be the cause of complications that occur. Surgical mesh products are made of synthetic polymers which may be combined with natural or animal tissue.
These components may produce allergic reaction or an immune response which leads to adhesion of tissues to form abnormal scar tissue or stick to other organs and tissues. The body may reject the mesh implant and cause it to migrate through the abdominal wall, impede other organs or perforate and severely injure abdominal organs including the intestines.
In addition, polypropylene, a synthetic polymer which may form the foundation for most surgical mesh, including Physiomesh, may degrade over time. This may result in shrinkage, irritation, pain and an immune response which may increase the chance of injury.
Hernia Mesh Recalls
Since surgical mesh was first used in hernia repair, thousands of adverse event reports have been filed with the FDA. Most of these reports have been filed for injuries or medical events related to infection, severe pain, bowel obstruction, adhesions and recurrence of hernia. In many cases, the patient was forced to undergo revision surgery to repair a recurrent hernia, remove previously implanted mesh and replace, or to repair damage caused to tissues and organs.
A number of surgical mesh products and manufacturers have been subject to FDA recall. C.R. Bard’s mesh product, Kugel hernia mesh was recalled in 2005, 2006 and 2007 due to risk of mesh breakage or degradation which may cause bowel perforation or development of an abnormal connection between organs, known as enteric fistula.
In 2012, Atrium manufacturer of C-QUR hernia mesh received an FDA warning letter because the company had failed to address a number of issues with their device including potential contamination of the manufacturing environment which may increase the chance for infection. The FDA subsequently issued a Class II recall for the C-QUR device which indicated that the product may cause at least temporary health risks. In 2015, the FDA filed a lawsuit against Atrium for poor quality control and temporarily halted production at their New Hampshire manufacturing plant.
Though not recalled by the FDA, in 2016, one product of the Ethicon Physiomesh line was voluntarily recalled by parent company, Johnson & Johnson. The manufacturer withdrew the product from the market after a high number of complaints and a review of multiple studies revealed higher than expected hernia recurrence rates. Ethicon stated that they would not return the product to worldwide availability, but they still continue to manufacture and market Physiomesh Open Flexible Composite Mesh Device in the U.S.
Physiomesh and Other Hernia Mesh Lawsuit Settlements
Over $1.1 billion has been paid in vaginal and hernia mesh settlements. In many medical injury lawsuits, hundreds, thousands or more cases that have been filed in federal courts will be consolidated into multidistrict litigation (MDL) cases. This allows for plaintiffs’ lawyers to coordinate information in cases that are similar. In these cases, a number of “bellwether” trials may be established so that a few of the first cases are taken to trial.
Once a jury verdict is issued for those cases, both plaintiffs and defending companies have an idea of how each trial would potentially be decided. In successful medical injury lawsuits, a large bellwether trial award will prompt a manufacturer to issue and offer for settlements for other members of the MDL case. Medical injury cases may also be filed in state and local courts which will not be part of a federal MDL procedure.
Ethicon and parent company, Johnson & Johnson currently face thousands of lawsuits. Many of the federal lawsuits have consolidated into two MDL cases in the United States District Court for the Northern District of Georgia and in the United States District Court for the District of New Hampshire. Trials are expected to begin in September of 2019.
Prior settlements of similar lawsuits against transvaginal mesh manufacturers may help determine what can be expected for claimants. In some cases, jury awards have reached into the $millions and over $1 billion has been paid by several manufacturers.
Hernia Mesh Manufacturers
In addition to the MDL cases against Ethicon/Johnson & Johnson and Atrium, a number of lawsuits have been filed against other manufacturers for injuries caused by their surgical or hernia mesh products. These include:
Ethicon / Johnson & Johnson
- Physiomesh Flexible Composite Mesh
- Proceed Surgical Mesh
- Prolene Hernia System
Atrim / Maquet / Getinge Group
- C-QUR Mesh and V-Patch products
Covidien / Medtronic
- Parietex Mesh products
C.R. Bard / Davol
- PerFix Mesh
- Kugel Hernia Mesh
- 3DMax Mesh
- Ventralex Mesh and Patch
- Sepramesh IP Composite Mesh
- Composix E/X Mesh
Filing a Physiomesh lawsuit
If you or a loved one have experienced complications after having Physiomesh or another hernia mesh product surgically implanted, you may be eligible for compensation for your injuries. Previous medical injury awards have compensated patients for medical costs, pain and suffering, lost wages, future medical costs and punitive damages. In some cases, these awards have reached into the $millions.
There are no guarantees as each case is unique and must be evaluated separately. It is important to have a potential medical injury evaluated by a legal expert as soon as possible. In most cases, a consultation or case review by a qualified medical injury specialist will be conducted free of charge. Most qualified cases are filed on a contingency basis, which means that the victim will not be required to pay anything unless a settlement is awarded.
Ethicon Physiomesh has caused patients a number of unpleasant side effects and is considered defective. The product has a high failure rate and many who have undergone procedures utilizing Physiomesh have needed follow-up procedures for repair.
Is Ethicon Physiomesh Dangerous?
It appears to be. Those who underwent hernia repair surgery that utilized Ethicon Physiomesh have experienced a variety of complications, including:
- Bowel adhesions and perforation
- Organ perforation
- Abdominal pain
- Mesh erosion or failure
- Need for revision surgery
Physiomesh Flexible Composite Mesh is manufactured by Ethicon, a division of Johnson & Johnson. The product was introduced to the market in 2010 but has caused problems for users from day one.
According to Ethicon, Physiomesh is a “sterile, low profile, flexible composite mesh.” It’s intended to help with the repair of hernias. It is constructed from non-absorbable macro-porous polypropylene mesh that is laminated between two pieces of film that is supposed to bond the layers together.
Physiomesh was approved by the FDA via its controversial 510(k) fast-track process. This allowed Ethicon to begin selling the product without as much testing as would usually be required on medical devices and products because it was similar to hernia mesh products already approved for market.
Ethicon’s Physiomesh quickly became the preferred product of doctors, in part due to the aggressive marketing by the company. Surgeons were told the product was superior to other meshes, though this has since been proven incorrect.
Hernia patients who underwent laparoscopic ventral hernia repair procedures utilizing Physiomesh experienced a higher-than-usual complication rate. There was a high rate of infection and wound problems, and many people with the mesh suffered from severe abdominal pain.
Ethicon Pulls Physiomesh from the Market
In the spring of 2016, Ethicon announced it would be removing its Physiomesh Flexible Composite Mesh from the US market after independent studies showed a higher rate of failure with the product. The withdrawal was classified by the FDA as a voluntary Market Withdrawal.
Market Withdrawal is similar to a recall, but it implies there is no official evidence of manufacturing problems. It also means that doctors and hospitals are not alerted with the same level of urgency.
According to Ethicon, the complications linked to Physiomesh might have been caused by the design of the product or could have been because doctors were given incorrect instructions or chose the wrong patients for the mesh.
Ethicon has never specifically identified the problem with the mesh, nor has it been able to give surgeons information about how to more safely use the mesh.
Though the recall prevents future patients from experiencing the pain and other complications associated with Physiomesh, it does nothing to help those who have already undergone hernia surgery with the mesh. Many are suffering severe complications and have permanent injuries because of their hernia repair surgeries. Even those who have not dealt with any problems yet have a high risk of complications in the future.
Did Ethicon Know of a Problem with Physiomesh?
Many familiar with the problems surrounding Physiomesh believe Ethicon was aware the product might be defective but still promoted its use to doctors. Many believe had the company warned surgeons and patients of the risk, many of the problems could have been avoided.
Investigations are underway to determine how much Ethicon knew about Physiomesh’s potential problems.
Accusations against the company include:
- Failure to adequately research and test Physiomesh
- Failure to warn doctors and consumers about the risks associated with Physiomesh
- Providing false and misleading information about the safety of Physiomesh
- Providing dangerous instructions to surgeons
- Failure to issue a recall in a timely manner
- Failure to pursue safer designs for Physiomesh
Those who have been affected negatively by the use of Physiomesh could have a great deal of pain and corrective surgeries in their future.