Manufactured by Johnson & Johnson’s Ethicon, Physiomesh is used to repair ventral hernias. This is when internal organs squeeze through a hole or weak spot of a previous surgical incision. Ventral hernias occur weeks, months or years after the initial surgery. Doctors can repair some with a few stitches. However, large and often complex hernias require major reconstructive surgery on the abdominal wall.
During the surgery, surgeons often use a hernia mesh-like Physiomesh to reinforce the abdominal wall to prevent a hernia from re-opening. Ethicon made Physiomesh from flexible, non-absorbable polypropylene filaments woven into a fabric and laminated.
The FDA originally approved Ethicon’s Physiomesh on April 9, 2010, using the FDA 510(k) approval program for the Physiomesh. This allowed the mesh on the market without rigorous safety studies, because it was “similar” to Proceed. Proceed is another hernia patch manufactured by Ethicon.
When Ethicon began receiving over 600 complaints from surgeons and patients, they submitted a modified version of the Physiomesh, Physiomesh Open, for FDA 510(k) approval on June 12, 2014. The FDA approved Physiomesh Open on October 23, 2014. Ethicon has sold over 337,950 units worldwide.
A pair of European registries in Germany and Denmark revealed the discrepancy between Physiomesh flexible composite and the other meshes in the registries after laparoscopic ventral hernia repair. The study noticed more patients experienced higher rates of hernias re-opening and additional surgery compared to similar products.
Dangers of Physiomesh
A pair of European registries in Germany and Denmark revealed the discrepancy between Physiomesh flexible composite and the other meshes in the registries after laparoscopic ventral hernia repair. Because it is made of polypropylene, the material can break down. This causes a hernia to reoccur, bacterial infections, or swelling at the surgery site. Most need more surgery to fix the issue. Ethicon suggests surgeons replace it with another one of their products: Proceed, Prolene, Prolene Soft or Ultrapro surgical mesh.
Another study ended early in 2014 after researchers found a significantly higher pain rate in the Physiomesh group after 3 months. Researchers found that the mesh had dense adhesions, especially to the intestines. Plus, it had poor incorporation into the abdominal wall.
Physiomesh Removal from Market
Until the two studies revealed the dangers of Physiomesh, Ethicon and Johnson and Johnson denied any complications from the hernia mesh. On May 25, 2016, Ethicon distributed an urgent field safety notice. The notice instructs surgeons to no longer use Physiomesh, yet Ethicon denies the mesh was “recalled”. Instead, they insist on using the terminology – voluntary withdrawal. The FDA does not even list Physiomesh as recalled on their website.
Other medical studies are currently underway researching the rates of hernia recurrence and additional surgeries following Physiomesh implantation. It is suspected these studies have also found high rates of Physiomesh complications, and this is why Ethicon withdrew the mesh from the market.
In the safety notice, Ethicon admitted the complications were possibly related to specific characteristics of Physiomesh, however, they claim to be unable to identify which ones.
Medical professionals had until September 16, 2016, to return unused Physiomesh for a full refund. Surgeons should examine their inventory immediately to see if they still have the mesh in question. Look for the product code in the upper right-hand corner of the foil packet, which contains the mesh.
The following table shows the recalled product codes.
Then, please fill out Ethicon’s Business Reply Form. This form is important to complete even if you do not have any of the recalled mesh.
If you had hernia surgery, contact your surgeon to know if he or she used Physiomesh Flexible Composite Mesh. Also, be vigilant at monitoring the symptoms of complications found most often with the hernia mesh. If you experienced any of these symptoms, contact us today.
The U.S. Judicial Panel on Multidistrict Litigation created a multidistrict litigation (MDL) for claims against Physiomesh makers Ethicon and Johnson & Johnson. MDL #2782 consolidates nearly 1,394 lawsuits pending in 36 different district courts across the country into one litigation in the Northern District of Georgia. This court is located in Atlanta. Judge Richard W. Story is presiding. There are 1,250 cases in federal court.
There have been over 3 million documents produced to date. Each side has picked 17 cases for inclusion in the Initial Discovery Pool. Then, by December 1, 2018, each side picks 5 of the 34 cases for expert discovery. The first trial is scheduled for September 15, 2019.
There is also MCL litigation in New Jersey that was filed in February 2018. In July 2018, the Supreme Court of New Jersey consolidated 100 Physiomesh claims. The next action will be in October 2018.
The side effects of Physiomesh can be painful and difficult to treat. These are:
- Intense pain
- Hernia recurrence
- Adhesion or scar-tissue fusing together
- Intestinal blockage
- Mesh migration
- Mesh shrinking
- A hole forming in neighboring tissues or organs
Since Physiomesh has a shiny, unporous coating, it is difficult for the mesh to adhere to surrounding tissue. This causes abnormal adhesions to form.
Speak to an Attorney Today
Doctors could have implanted an estimated 300,000 people with Physiomesh during hernia surgery. If you or a loved one had hernia recurrence or hernia surgery, you need an attorney with experience helping people who have been harmed by pharmaceutical companies. The attorneys at the Michael Brady Lynch Firm know what it takes to go up against these manufacturers to get clients what they need.
How We Can Help
When you experience side effects, it can have devastating effects on your entire life. In fact, you may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
Furthermore, if a person dies from complications, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If a suit finds the conduct of a company in manufacturing and selling a product to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you developed a hernia reoccurrence after surgery, please speak to us to learn more about your rights.
Case evaluations are free of cost and without obligation. Therefore, call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.