Once again a medical device is harming unsuspecting patients. Horror stories of injuries related to transvaginal mesh have been in the media for the past decade. Now, a new mesh product appears to be causing injuries.
After overwhelming evidence of a problem, Ethicon—a subsidiary of medical giant Johnson & Johnson—recalled its Physiomesh brand mesh products that were most often used in laparoscopic and ventral hernia repair surgeries. Scientific studies showed that the failure rate for the Physiomesh was higher when compared to patients implanted with other hernia repair mesh products.
Ethicon began advertising its polypropylene mesh patch in May 2010 as a faster and less painful surgical option for hernia repair. A closer look revealed that the polypropylene used in Physiomesh broke down, causing severe consequences for unsuspecting patients. Many patients in Kentucky and across the United States are experiencing adhesions, recurrence of their hernias, and severe pain.
Serious Injuries Caused by Physiomesh Hernia Mesh
Ethicon’s Physiomesh isn't made like most mesh products with materials that are absorbed by the body over time. Ethicon’s mesh uses a thick polymer film to allegedly provide support for the mesh. These films, however, cause the body to fail to work with the mesh and reject the mesh as a foreign body, causing devastating reactions. This rejection is sometimes known as a “chronic foreign body reaction.” Rather than the body absorbing the mesh it simply grows on the mesh. This process can lead to terrible pain, inflammation, adhesions (scar tissue), and chronic infection.
Problems began to be reported not long after patients started having the mesh implanted by their doctors for hernia repairs. The most common problems are:
- Chronic infection
- Bowel obstruction
- Shrinkage of the mesh
- Migration of the mesh
- Tearing of the mesh
- Hernia recurrence
- Inflammation of the area surrounding the mesh
- Abdominal Adhesions and scarring causing pain and obstruction of organs and tissues
- Fluids building up under the skin (called seroma)
- Rejection of the mesh as a foreign body
More often than not, patients suffering problems due to mesh will require a second surgery to remove the mesh and repair the damage it has caused. In some cases a third and fourth surgery have been required.
When Did Ethicon Know About Problems With Physiomesh?
Ethicon declined to test their mesh product on humans in an effort to get it to market quickly to start making sales. They were able to bypass these tests by claiming such tests were unnecessary because their mesh was so similar to other products already on the market. Incredibly, despite Ethicon skipping the additional safety tests, the FDA approved the mesh to be marketed using its 510(k) approval program. Once it received this approval, Ethicon hoped for the best and started trying to sell as many mesh patches as it could.
Physiomesh hernia mesh, however, was not as similar to other mesh products as it had promised. The differences in its design, specifically the polymer film coating, began showing signs of complications early on. Investigators have argued that preclinical simulated tests did not provide much positive feedback concerning the efficacy of the mesh; including:
- Some early results showed the mesh was producing adhesions.
- Other results showed the mesh had shrunk from its intended size and had migrated from its intended position.
Many physicians have claimed they were not informed of these adverse test results when marketed this mesh for hernia repairs. There were over 90 adverse event reports filed by surgeons and other physicians by the end of 2012. Currently, there are over 650 adverse event reports filed in the FDA’s MAUDE adverse event reporting system.
Critics have suggested that had Johnson & Johnson not rushed approval of the Physiomesh through the FDA’s highly controversial 510(k) process, the problems surrounding Physiomesh would have been apparent before it was mass-marketed to thousands of patients. Instead, patients began reporting problems with the Physiomesh as more and more patients were being implanted with the mesh. This occurred up until the time of the recall was issued in 2016.
Despite these concerns, Ethicon/Johnson & Johnson developed and marketed Physiomesh Open in 2014. Patients implanted with this hernia mesh are being closely monitored.
Johnson & Johnson’s Hernia Mesh Recall
Johnson & Johnson (Ethicon) issued what is a known as an urgent field safety notice on May 25, 2016, which included a recall of existing Physiomesh stock currently being stored by health care facilities and hospitals. Ethicon has claimed the recall was due to many issues that might be causing a potential high recurrence rate for hernias in patients implanted with the mesh. It claims the issue is still being investigated.
The recall was issued for all variations of Physiomesh; including:
These mesh products came in a variety of shapes (oval, rectangle, square) and sizes (7 cm by 15 cm to 30 cm by 50 cm). If you are unsure of your product type, contact our Louisville defective medical product lawyers for help.
Doctors had until September 16, 2016, to return any unused Physiomesh hernia mesh for a refund. Many surgeons followed the recall suggestion and discarded or turned in their unused mesh.
No Recall Issued For Implanted Physiomesh
There has been no recall for implanted mesh but Ethicon has recommended that surgeons with patients injured by Physiomesh implants replace them with a different Ethicon mesh brand: Proceed, Prolene, Prolene Soft, or Ultrapro mesh.
Unfortunately, it is estimated that over 300,000 patients in Kentucky and throughout the United States may have been implanted with Physiomesh since the product was approved in 2010.
Physiomesh Hernia Mesh Recall Lawsuits
Multiple lawsuits have been filed against Johnson & Johnson for injuries related to Physiomesh used for hernia repairs. One of the first lawsuits filed alleged that the patient became infected around the area of the mesh, causing abscesses as well as a serious abdominal fistula to form. The patient required multiple surgeries to repair these injuries. Other lawsuits have alleged the mesh caused bowel obstructions and severe pain.
Our office has spoken with many alleged victims of Physiomesh. Many of them have experienced urinary and digestive problems as well as chronic pain. Unfortunately, most have required additional surgeries to repair the problems caused by the hernia mesh.
Filing a Hernia Mesh Lawsuit in Kentucky
In Kentucky, you may have as little as a year to file a lawsuit once you know or should have known that you have injuries due to mesh implants. In some circumstances you may have longer. Therefore it is very important to contact an attorney as soon as possible if you believe you may have mesh-related injuries.
Our team of lawyers and nurses at Gray & White Law can tell you if filing a mesh lawsuit is possible. Contact us for a free, no obligation consultation by calling 888-450-4456 or by submitting the contact form on this page. If you are unable to get to us, we can come to you.
More Information for Victims of Surgical Mesh Injuries