Hernia Mesh Complications- Is the FDA Watching? Part II
November 28, 2012 ~ Continuation from Part I, According to hernia mesh removal surgeon, Dr. Kevin Petersen, in a certain percentage of patients, the body will detect hernia mesh as a foreign material and will reject it.
Symptoms may include scar tissue that leads to chronic pain and causes mesh to shrink and shrivel up, pulls on its anchors which can detach and dislodge and free itself from the hernia.
Dr. Petersen has been removing mesh at his No Insurance Surgery Center in Las Vegas. He does not use mesh. He says in a YouTube video he’s probably done 5,000 hernia procedures and has been a surgeon for 25 years.
Dr. Petersen claims non-mesh repair has a recurrence rate of less than 3 percent.
Kristina Graham will be visiting Dr. Petersen for a mesh removal at the end of December.
The 34-year-old hairdresser from Carey, North Carolina was in a car accident and the seat belt caused trauma to her abdomen. The doctor treated it like an inguinal hernia and implanted Ethicon Prolene Hernia mesh.
Graham had pain right away and was told it was nerve damage. Another doctor surgically removed nerves but put in more mesh. Since February 2012, Graham says she’s been walking around like she was shot in the abdomen.
She was told to suck it up and go back to her hardcore workouts – weights and running. She was sent on the round robin of doctors and to a physical therapist for pelvic floor massage. The gynecologist said she had cysts.
Graham is slim and healthy, eats organic food and drinks plenty of water but the swelling has spread from the incision to her hip and public bone.
“I did everything I was told and finally they said get pain meds and just get comfortable. I’m 34-years-old and have a 2 and 4-year-old. That’s not the life I want,” she says today. “Nobody wanted anything to do with it, they said removal wasn’t possible.”
Graham’s insurance company checked with nearby hernia surgeons and the consensus was no one wanted to clean up someone else’s mess. That is how Graham got the referral to Dr. Petersen for the out-of-state removal surgery.
Graham says she was not told about the potential for complications prior to mesh surgery.
“If I had known the reality I would have different things to say. Doctors don’t want you to know.”
Graham wants people to be proactive when it comes to their own health. She has spent time finding procedure codes to get her insurance, Blue Cross Blue Shield, to pay her back for the procedure with Dr. Petersen.
“This surgery has to happen through their network providers and if they can’t do it, they will pay for going out of network. I pay the doctor and they pay me back. They talk to 100 providers on the list and when 100 won’t do it, they let you go out of state. That’s the law. That’s another thing people need to know.”
Graham has her medical records and with that information plans to file a complaint with the FDA’s MAUDE database (Manufacturer and User Facility Device Experience Database). It is the only way for the agency to track the real injuries occurring among patients treated with an FDA approved medical device. Follow the MDND procedure on doing that here.
Search the MAUDE database to pull up reports done by others injured by the same medical device as yours. For example, this is an adverse event reported August 24, 2011 concerning an Ethicon Prolene Mesh Hernia system implanted July 14, 2004, as seen here:
“I had hernia surgery in (b)(6) 2004 and they put Ethicon prolene mesh in me. I was fine until (b)(6). Now i have severe pain where the surgery was done and all the way down into my penis. I am sick to my stomach and hurt like a stabbing feeling and needles sticking me. Everything i read says it is the mesh but now i have no insurance and i am trying to hold on as long as possible but it is getting really hard to handle the pain much longer. I got my medical records from the surgery but i really don’t know how to tell what mesh is recalled. I just know mine is hurting.”
Ethicon, a division of Johnson & Johnson, produces the Prolene Hernia System. Prolene is the company’s trademark name for polypropylene mesh. Other brands of hernia mesh from Ethicon include Proceed Mesh, Prolene 3D Patch Mesh, among others. The Ethicon Prolene Hernia System and Bard 3D Max Mesh are products commonly used to repair hernias. See their brochure here.
Here is a Topix page on hernia mesh
Dr. Kevin Petersen on Non-Mesh Surgery (video) Open non-mesh repair
Hernia brochure American College of Surgeons
Here is how to search for a complication by putting the name of the mesh in the search box.