Hernia Mesh a Helluva Mess

Raleigh, NCDaniel complained to his surgeon time and again about pain and swelling from his abdominal surgical mesh used to repair a hernia back in 2015, but he was told it was simply the "healing process" and that "time would heal". But how long does the healing take? In Daniel's case, time was not on his side.

"Immediately after the abdominal mesh surgery I began to have problems and they have worsened. I talked to my surgeon and my GP a number of times, but my complaints fell on deaf ears," says Daniel. It wasn't until Daniel saw a legal advertisement on TV about hernia mesh lawsuits that he understood the pain wasn't going away. He finally was able to get a second opinion, but not before an arduous battle with his insurance company to cover a second surgeon's costs and the hospital to get his medical records.

"It took more than a year to get another surgery and no wonder I was in so much pain," says Daniel. "My new surgeon told me that some tissue had started to grow around the mesh and it was almost impossible to straighten it out," Daniel adds. He was initially booked for laparoscopic surgery, which reduces recovery time for hernia repair, but the mesh was so difficult to remove that the surgeon had to perform a traditional hernia surgery. And rather than going home that day, Daniel spent the next two days in hospital.

Ethicon Physiomesh

"When I woke up I had an IV drip with morphine. My surgeon told me that he wanted to keep a close watch for any complications rather than discharge me right away, like the first laparoscopic surgery," says Daniel. "But he wasn't able to get all the mesh removed as some bits had eroded into my small bowel. So, I am now facing more surgeries or the rest of my life in pain."

Daniel isn't the only one with this specific complication. In a case report published in the Journal of Minimum Access Surgery (Jan 2016), a 62-year-old man suffered mesh erosion of the small bowel and bladder after laparoscopic inguinal hernia repair. The researchers concluded that "Mesh erosion/migration should be suspected in any patient presenting with regional pain, urinary or bowel symptoms following laparoscopic mesh hernia repair in the past."

Daniel considered filing a medical malpractice lawsuit against his original surgeon, but when he dug into his medical records and found the mesh used to repair his hernia was Ethicon Physiomesh, he went online and discovered it had been withdrawn from the market - about one year after he had the Physiomesh implanted. "I can't help but wonder if my surgeon knew about the problems associated with this mesh. Surely the medical device company knows where its products go. Why didn't the hospital follow up and tell me? I was furious. And I was madder still when I went online and saw how many Physiomesh lawsuits have been filed against the manufacturer."

Ethicon and the FDA

Daniel should also be angry with the FDA - it approved several hernia mesh products via the 510 (k) fast-track process, which allows a new medical device to enter the market without first undergoing human clinical trials if a manufacturer can show that it is substantially equivalent to a previously-approved product. In other words, one could argue that thousands of people implanted with these abdominal mesh products were taking part in a clinical trial without their knowledge. Without their consent or compensation.

Interestingly, the agency says that, since the 1980s, there has been an increase in mesh-based hernia repairs-by 2000, non-mesh repairs represented less than 10% of groin hernia repair techniques. It fails to mention the correlation in the rise of hernia repair complaints after 2000, but goes on to say in an article published in April 2016 - one month before Ethicon withdrew its Physiomesh Flexible Composite Mesh from the market (it was recalled in other countries) - the following:
"Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh…In the FDA's analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications."

Ethicon Physhiomesh Federal Lawsuit

As of the beginning of 2018, over 460 hernia mesh lawsuits are pending in federal court and the first Physiomesh trial is scheduled for September, 2019. The parties are to each select 12 cases for inclusion in an Initial Discovery Pool by mid-May, 2018, and those Ethicon Physiomesh lawsuits eligible for the pool include all of those currently pending in the litigation that were filed as of January 11, 2018. For more information, check the Practice and Procedure order. Daniel is hopeful that he will receive some compensation for years of pain, and loss of wages, and loss of quality of life.