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.