Problems with Prolene Hernia Mesh System

Hernia mesh is the favored method by surgeons to repair inguinal hernia repair however some mesh devices have higher failure rates than others leading to health complications and chronic pain.  Ethicon, a subsidiary of Johnson & Johnson, manufactures and markets the Prolene Hernia System which has been on the market since 2000.  The system is composed of two separate layers of mesh connected by a mesh tube, and it is usually used for inguinal hernias, or hernias of the groin. Prolene mesh is made of polypropylene.

The FDA approved the Prolene mesh through a 501(k) process meaning that since the Prolene system is substantially similar in design to previously approved medical devices Ethicon's Prolene system was not subject to rigorous testing.

When mesh fails and requires further surgery, a patient may experience significant pain, systemic infection, scarring, mesh erosion, urinary issues, nerve entrapment and extended hospital stays. Complications associated with this mesh include sexual dysfunction, removal of a testicle, revision surgery, hernia repair surgery and severe pain.

Nearly one-third of people who undergo hernia surgeries experience some sort of complication, with excessive pain being the most frequent complaint, according to one study.

The U.S. Food and Drug Administration describes adhesions as “scar-like tissue that sticks tissues together.”

Chronic, often severe, pain may be a patient’s only symptom of a mesh adhesion. The condition can also lead to life-threatening bowel obstructions.

According to a 2016 JAMA article, "A study of 3,200 patients found hernias were less likely to return if repaired with hernia mesh. But the study also found the risk of long-term complications off-set that benefit.”

You should speak with an attorney in order to determine whether you are eligible to file a lawsuit due to injuries you sustained after receiving a Prolene mesh implant. However, there are a few things you should consider before reaching out to a law firm.

  1. Did your hernia mesh surgery occur sometime between 2010 and the present?
  2. Did you develop pain, infection, or other detrimental effects, such as those listed in the list above, after your hernia mesh surgery?
  3. Has a doctor recommended that you go in for revision surgery (a second surgery whereby the mesh will be altered, removed, or replaced?)
  4. Have you already undergone revision surgery?

If you answered yes to any of the questions listed above you should strongly consider speaking with a lawyer. Currently there are over 100 Prolene Hernia System mesh lawsuits pending, and many more are expected to be filed in the coming months.

Rheingold Giuffra Ruffo & Plotkin LLP has filed cases for those negatively affected by the Prolene Hernia System and is currently involved in litigation.