You Think it Might be the Polypropylene?
Mesh Medical Device News Desk, November 20, 2017 ~ Bruce Rosenberg is a patient advocate and hernia-mesh injured man living in Florida.
If you have called Mesh News Desk looking for answers about your hernia mesh and the complications you’re suffering, you will be sent to Bruce.
He questions whether the problem with all meshes might just be the polypropylene plastic its made of.
There is a steady increase in the number of calls coming into Mesh News Desk and Bruce Rosenberg. Bruce takes an average of 20 calls a week from people with hernia mesh complications. And there is no particular model or mesh manufacturer people have problems with.
Rosenberg says the common thread is that the majority of hernia mesh is made from polypropylene (PP), a polymer plastic that comes from the petroleum industry.
Hernia mesh complications might include mesh contraction, migration, erosion and/or adhesion to nerves, spermatic cord, bowel and bladder.
Rosenberg says, “We’re noting an increase in the number of law firms interested in taking hernia mesh cases which is a sharp departure from the transvaginal mesh litigation.”
“The theory is that coatings on hernia mesh disappear too soon,” he says.
The Atrium C-Qur mesh was approved by the FDA through the 510(k) approval program in 2006. Its marketing promises it is “film coated mesh” and there is a coating made of all natural Omega 3 gel coating from fish oil, according to Atrium.
The FDA issued a Field Safety Notice to Atrium Medical in 2012 warning the manufacturing and sterilization process for C-Qur was altered and that numerous infection complications were not being investigation.
Atrium issued a safety notice to its customers (here) warning that the coating could adhere to the packaging sleeve, but C-Qur mesh remains on the market while the Edge was discontinued. There was no word from Atrium what happens when the mesh is exposed to excessive humidity for an extended period of time in the human body.
Physiomesh was removed from the market by Ethicon (J&J) in May of 2016, though Ethicon denies it was a recall.
Independent studies had shown high rates of patient and surgeon complications. The coating on Physiomesh reportedly prevents the bowel from being exposed to the polypropylene which doesn’t allow it to incorporate properly into the abdominal wall.
The adhesion of PP is the cause of pain and otherwise injuries to nerves, the bowel, ureters and that the coatings may not be the entire issue.
“The coating may not be the only problem,” says Rosenberg.
“I’m suggesting that patients who may be seeking legal representation are likely to have a variety of problems, most of which the commonality is that they are made of polypropylene.
Just because an attorney or doctor tells you, you don’t have one of those meshes on recall or that law firms are soliciting for in litigation, that does not mean you might not be having problem with your PP hernia mesh.”
Rosenberg says mounting scientific evidence presented in trial testimony suggests ultimately we may finally find polypropylene is the culprit. ###