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Hernia Mesh Complications- Is the FDA Watching? Part II

Dr. Kevin Petersen, YouTube, No Insurance Surgery

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

Kristina Graham and family

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.

 

Learn More:

Here is a Topix page on hernia mesh

http://www.topix.com/forum/health/TE4DF83JKBNACOFNO/p226

Dr. Kevin Petersen on Non-Mesh Surgery (video) Open non-mesh repair

http://www.youtube.com/watch?v=LopM7hLFV_s

Hernia brochure American College of Surgeons

http://www.facs.org/public_info/operation/brochures/hernrep.pdf

Here is how to search for a complication by putting the name of the mesh in the search box.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/textsearch.cfm

 

33 Comments

  1. Kathleen Bahr says:

    Has anyone begun a lawsuit for mesh that is not related to bladder issues?

  2. Kerry Wilson says:

    Hi Jane, thank you so much for the lead to Professor Richard Reid in Sydney Australia.

    My GP wrote to him, he rang her and had a long conversation about me, the upshot of which is he says “I am classic mesh and it needs to come out”. I have an appointment to see him on 30/1/13.

    For the first time I feel a bit hopeful of resolution. Any suggestions for questions I should be asking him before mesh removal? Again, thanks a million.

    • Jane Akre says:

      Did you have hernia or vaginal mesh?

      • Kerry Wilson says:

        Neither, I have a stomach full of mesh when they did a tram-flap reconstructioin (made a new boob from the stomach tissue) after breast cancer mastectomy three years ago and have got progressively worse by the week since then.

  3. Tracie Davis says:

    Have had nothing but problems with my inscisional hernia repair in 2010. Bard composix 8x10mesh.

    • Kelli says:

      What kind of complications? I had incisional hernia repair with prolene mesh a year and a half ago and immedialtely developed a knot under my skin to the right of my incision. as time went on it was no longer painful but still there and now over the past week has become painful and split open and draining. Have you experienced anything like this?

      • Jane Akre says:

        Kelli- You may want to call Bruce Rosenberg at the Meshoma Foundation 954-701-5094 brosenberg1@bellsouth.net he is hernia mesh injured and very knowledgeable. It doesn’t sound good though…

        • Jessica says:

          I had inguinal surgery 3 yrs ago and mesh was used. It seemed to heal up ok though there is still a lump next to my incision scar. Last summer I ramped up my hill interval running workout for 2 wks and since then I have been dealing with a lot of pain. I am on diclofenac continually in order to have a quality of life and actually sleep. I have been 2 numerous drs who have ruled out disc, nerve and other issues via exam and MRIs. I am so discouraged and in pain! Anyone out there ever have a delayed pain reaction due to the hernia mesh after the initial healing process??

          • Jane Akre says:

            Hi Jessica…. Bruce Rosenberg is a hernia mesh injured guy who is an incredible wealth of information.. He has a nonprofit Meshoma Foundation and would be a good person for you to contact 954-701-5094. Thanks for writing~ ja

  4. Tracie Davis says:

    Have had nothing but problems with my inscisional hernia repair in 2010. Bard composix 8x10mesh.

  5. Richard says:

    Recurrence rate with mess is less than one percent and the Prolene 3D patch is even better so if this article is correct and the non-mesh recurrence is three percent you have your answer .

    So some people have trouble with a mesh repair. It may not be the mesh but a surgeon without enough experience.

    • Jane Akre says:

      Richard~ Your comment raises a troubling question? Are there really that many bad surgeons? Being that mesh was not tested prior to being sold, I’d be curious about your sources for recurrence rate with mesh… Also are you considering the quality of life?

  6. Charrissa Jackson says:

    I had double hernia repair done November 21, 2011. Since then I have had nothing but problems. My stomach bulges and is tender to the touch at my belly button. It is also warm to the touch. Im in constant pain and have had nerve blocks to try and ease the pain. Nothing has helped. Seen numerous doctors who all tell me there is nothing they can do to help me. The pain is radiating down my legs. I coach basketball and before I had this surgery I was in the best shape of my life. I now have a 2 year old grandson who I cant enjoy playing with because Im in so much pain. I just want someone to help me and let me get back to a better life

  7. I had bi-lateral lap. inguinal hernia surgery May 14th 2014. Started having problems soon after (3 to 4 weeks), pain in surgical areas where 3d Max mesh was placed as well as swelling. Ultra sound was performed 58 days after surgery and it showed hernia was present on left side. Since then pain on right side has increased and I’ve been experiencing joint pain in area not related to surgical site (left arm elbow) continuously for over 30 days now. could this pain be related to rejection of mesh by my body? Right side abdominal pain is sharp like being stuck by something, also feels much like pain experienced prior to surgery.

    • Neil Richards says:

      Hi Anthony, I have experienced the same post surgery problems as you, not sure what to do, have you been able to come up with a solution since your www post?

  8. Ed Price says:

    IN 09 I had bilateral inguinal hernias repaired laproscopically. Using Bard 3D max. It has been a living Nightmare ever since!! Mass Pain from incision sight down through gentiles and front of thighs. Burning and tingling, Prostate enlargement almost immediately!The quality of my life is GONE!!!! Only by the Grace of GOD am I able to go on. I was NEVER told about any possible side effects to surgery or mesh. Grace and mercy to all of you out there who suffer as do I.

  9. Tom Burke says:

    On 3/17/11, I underwent a large ventral/incisional hernia operation. The hernia was repaired using Ethicon prolene soft mesh. Subsequent to surgery, I began having horrible abdominal pain, and after many tests it became clear from a CT Scan in July of 2012, that the hernia was recurring, but the cause was not known. The July CT did NOT reveal a mesh malfunction.

    On 10/26/12, I underwent the identical surgery where it was revealed that the prolene mesh had completely tore away or completely disintegrated from the fascia from which it was sutured, causing recidivism of the hernia.

    For purposes of Statute of Limitations, this case must be filed before 10/26/14.

    After the hernia was repaired with Bard/Davol ventralex ventrio mesh on 10/26/12; I began having the same issues with pain, stabbing pain in my abdomen and other issues concerning serious discomfort. Within the last few months the pain has elevated to 10/10, and a fairly large abdominal protrusion is AGAIN forming in the identical area where this second repair was performed!! My surgeon believes the ventralex mesh has malfunctioned, or torn/ripped; and is again causing recurrence of the ventral/incisional & now umbilical hernia!!!

    Please contact my ASAP!!! If you are not handling this type(s) of hernia mesh cases, please refer me to an attorney who is; and if there are class actions pertaining to both prolene and ventralex mesh malfunctions, please provide all pertinent contact information.

    I’d appreciate speaking with a partner level attorney who is handling these type of lawsuits.

    Thank you,

    Tom Burke

    312-259-2625

    Tjjburke@aol.com

  10. Tom Burke says:

    I NEED LEGAL HELP!!!

    On 3/17/11, I underwent a large ventral/incisional hernia operation. The hernia was repaired using Ethicon prolene soft mesh. Subsequent to surgery, I began having horrible abdominal pain, and after many tests it became clear from a CT Scan in July of 2012, that the hernia was recurring, but the cause was not known. The July CT did NOT reveal a mesh malfunction.

    On 10/26/12, I underwent the identical surgery where it was revealed that the prolene mesh had completely tore away or completely disintegrated from the fascia from which it was sutured, causing recidivism of the hernia.

    For purposes of Statute of Limitations, this case must be filed before 10/26/14.

    After the hernia was repaired with Bard/Davol ventralex ventrio mesh on 10/26/12; I began having the same issues with pain, stabbing pain in my abdomen and other issues concerning serious discomfort. Within the last few months the pain has elevated to 10/10, and a fairly large abdominal protrusion is AGAIN forming in the identical area where this second repair was performed!! My surgeon believes the ventralex mesh has malfunctioned, or torn/ripped; and is again causing recurrence of the ventral/incisional & now umbilical hernia!!!

    Please contact my ASAP!!! If you are not handling this type(s) of hernia mesh cases, please refer me to an attorney who is; and if there are class actions pertaining to both prolene and ventralex mesh malfunctions, please provide all pertinent contact information.

    I’d appreciate speaking with a partner level attorney who is handling these type of lawsuits.

    Thank you,

    Tom Burke

    312-259-2625

    Tjjburke@aol.com

  11. Steven says:

    The reason for pain after a hernia operation is usually down to the material used. Polypropylene which is used in most meshes is not the correct material to be using. It creates lots of scar tissue which will lead to a feeling of tightening and pain. You need a mesh that has less scar tissue reaction which allows vascularisation (formation of blood vessels) to take place. If the scar tissue reaction is too high, blood vessels cannot grow around the mesh and are unable heal any infected areas.

    • Eileen says:

      Dear Steven,

      I am not sure if you are a Dr but if Polypropylene is not the correct mesh material to use in hernia repair…..what type of material mesh is?

      I have to schedule a hernia repair and I am so overwhelmed by online info. My priority is to find a hernia specialist in Long Island NY or Manhattan NY who does non-mesh repair but have been unsuccessful in finding one…it looks like I have no choice with mesh. (Any advice is greatly appreciated). -eileen

      • Jane Akre says:

        Hi Eileen…. Check with Bruce Rosenberg, a patient advocate and hernia mesh injured. he is very knowledgeable about mesh, doctors, repairs, etc. He has helped guide many …954-701-5094. Very reasonable and fact based info. You will like him. Keep trying, he can be hard to reach.

  12. Benai says:

    Hi I need help.

    I had a prolene mesh inserted after hernia repair from a gastric bypass surgery. I have lived with excruciating pain for the last 12 years and its getting worse. I call them episodes cause thats all I can call them. I have had numerous CT SCANS done since and the doctors say it looks like a bomb went off inside and they’renot sure how to proceed seeming the gastric bypass has changed dramatically since I had the first initial surgery.

    Im trying to find out what the best solution moving forward as I cannot live with this pain any longer. Its taking over my life.

    Any help would be soo much appreciated.

  13. sandy says:

    On October 31, 2006 I had a ventral hernia repair in my abdomen. At that time I had a fascial reapproximation with lateral relaxing incision and a 12 x 12 inch piece of vicryl mesh placed as an overlay. I had complication with this surgery involving a seroma and a wound infection. The surgeon had stated that the vicryl mesh would dissolve. Needless to say I spent a year on a wound vac and a year later surgery discovered acute and chronic inflammation with hemorrhage and necrosis. I continued having reoccurring pain in the abdomin

    In August of 2012 I was in the hospital with sepsis. I collapsed on the gurney with 104 degree fever and extremely low blood pressure. They had infused me with so many fluids to get my blood pressure up that my legs and feet had ballooned that I could not wear my shoes. I was in the hospital ICU unit for a week and I was discharged on a Friday and my son was getting married Saturday. I had to wear flip flops and I was extremely embarrassed. Basically, I was lucky to be alive.

    In January 2014 I was hospitalized with sepsis, kidney failure, and acute bronchitis. I was in the hospital (ICU) for a week and when I was discharged I was very weak and I had developed a blood blister on my abdomen. My doctor was not sure what the blood blister came from and I was discharged on a Friday even though and my abdomen was sore. I was weak and I had fallen and the blood blister had broken (Saturday). I was taken to the hospital by ambulance and underwent emergency surgery twice to clean the dead tissue from my wound. The surgeon told my family it was very serious and it was possibly I would not make it. My abdomen was filled with dead tissue. I had a serious bacterial infection known as necrotizing fasciitis. Necrotizing fasciitis is an infection that starts in the tissues just below the skin and spreads along the flat layers of tissue (known as fascia) that separate different layers of soft tissue, such as muscle and fat. My infection was located in my abdominal wall and is fatal in 30%-40% of cases.

    Necrotizing fasciitis is a term that describes a disease condition of rapidly spreading infection, usually located in fascial planes of connective tissue that results in tissue necrosis (dead and damaged tissue). Peritonitis is an inflammation of the peritoneum, the tissue that lines the inner wall of the abdomen and covers and supports most of your abdominal organs. Peritonitis is usually caused by infection from bacteria or fungi. Necrotizing fasciitis is a serious condition that is often associated with sepsis and widespread organ failure. Necrotizing fasciitis refers to a rapidly spreading infection, usually located in fascial planes of connective tissue that results in tissue death (necrosis). Peritonitis can rapidly spread into the blood (sepsis) and to other organs, resulting in multiple organ failure and death. The first symptoms of peritonitis are poor appetite and nausea, and a dull abdominal ache that quickly turns into persistent, severe abdominal pain, which is worsened by any movement.

    An internal fistulae—(when an abnormal connection develops between organs that do not usually connect). The surgeon discovered that I had a bowel perforations caused by the vicryl mesh. The contents of the bowel flowed into my abdominal cavity, leading to a variety of problems, including peritonitis. I have an open wound on my abdomen 22 cm wide by 18 cm. The surgeon stated that this was the largest wound he ever dealt with. I was in the hospital for approximately a month and then sent to a nursing home for a month. I had a wound vac on my abdomen. I had other numerous admissions to the hospital during this time. I also was on TPN (this was liquid nutrition) that is intravenously given to me through a pic line that was inserted into my arm. I am not allowed to eat or drink. From January 2014 to this present day I have been on TPN. I missed Valentine’s Day, my birthday, Easter, Mothers Day, Memorial Day Family Picnic and many social events and special occasions being on the TPN.

    The TPN makes me nauseous and I end up vomiting. Some days it’s all day long. It also disrupts my sugar levels. They run anywhere from over 200 to 150 since I have been on the TPN. I get dizzy and lightheaded and my hands shake.

    Evangelical hospital had referred me to a Geisinger surgeon for additional follow up. Evangelical hospital felt they were unable to perform this complex surgery and I needed to go to a specialized hospital. My appointment was in April of 2014 and I am looking at additional surgery in July as soon as my abdominal wound heals. The surgeon stated that when hernia’s operations were done it was common practice to stitch the mesh to a major organ and they have had numerous problems with this procedure with the mesh perforating a major organ. In my case it was the bowel. My mesh was supposed to be dissolvable mesh; however, a portion that was stitched to the bowel was still present.

    Since the surgery I continued with episodes of vomiting, headaches, abdominal pain, Abdominal deformity, Hernia recurrence, Infection, Inflammation, Pain & swelling, and frequent sicknesses, and numerous aches and pains.

    The surgery was scheduled for July 24th. I had a bowel resection and removal of the mesh

    Was the vicryl mesh ever recalled?

  14. Hi have always has Palm n uta a femoral hernia done twice first time no mesh came back out second time …. anyone know anything for me to do send to gab.Strelko@Gmail.com

  15. Alberto trujillo says:

    Hi my name is Alberto I live in New York City in 2009 I had bilateral inguinal hernia repair surgery with 3D max prolene mesh 2 week after my testicle went crazy a lot of pain swelling infection but the surgeon refused to remove it even thou urologist advised hem to do so so another surgeon went in but he did not remove the mesh he stand that the mesh creating a lot of scar tissue that compress the area but in one month the mesh migrate and end up in the mid line and stared having adhesion with the colon and the bladder things stared getting crazy bladder stop working so they put a supra public Cather and thing was worse chronic UTI fistulas and 3 more surgery that adhesion cause the colon to have diverticulitis I still have pieces of the mesh along the sigmoid colon with a lot of inflammation I’m hospitalized every month with infection and blablabla and I put all the complain to the FDA and honesty they have done anything. Davol company just tric me lawyers just play I do not what to do or how I make the responsible for all my pain and suffering to pay what happen to me in my experience I just find out that the law is not balance like I thought it seem that the big always win if some one know how to do things please just let mi know how thanks and have a nice day

  16. Angela Doster says:

    I have a hernia mesh surgery can’t remember when exactly but I hurt at belly button area and pain shoots to my back, belly button stays red and sore can’t put pants on my belly area and I have bacteria infection alot in my belly since I have the surgery should this concern me ,I also can’t eat alot nomore it’s like I’m full but about 30 mins later I’m starving can’t put alot of pressure on my belly and think I have a hernia near my ribs in the middle of my chest is that possible…..

    • Jane Akre says:

      You might give Bruce Rosenberg a call 954-701-5094- he is a hernia and repair expert and hernia mesh injured himself…..

  17. Kat Mac says:

    I had a hernia repair 5/2014, and have had a lot of pain, can’t eat food, hurts to wear pants with buttons and the lump is getting larger as time goes by.

  18. William says:

    I had an inguinal hernia repair with mesh last spring. The website of the doctor states they use the Prolene Hernia System mesh, a polypropylene mesh. I had far more pain to begin with than they thought I should have, then sent me back to work at 18 days after surgery saying “full duties” (workers’ comp.).

    I healed up but waited before doing any working out again. Still, right away I began noticing continued discomfort, then (embarrasing, & I’m unmarried),…pain during ejaculation. I feel pressure, discomfort, and even burning pain, sometimes even beginning with mere arousal. Definitely a problem that was not there previously. Also, (sorry), my BBs don’t get much “distance”.

    Lately, I was in pain all day before it subsided more. I began wondering if the mesh slipped or could get frayed. There is irritation along and below the incision, which is about 3 1/2″ long and just above the crease of my thigh. I have read today that there can be slippage and bunching of the mesh and that it can be hard to take out or correct. NOT happy. I also have wondered prior to that if they somehow crimped or damaged my vas deferens, but maybe the info coming up online about the mesh problems is what the real situation is.

    I just hope it doesn’t go too badly for me. I can’t afford this. My employer keeps putting it off on the ins. provider of theirs, and the ins. co. won’t help. (sigh)

    • Jane Akre says:

      William contact Bruce Rosenberg hernia mesh injured patient advocate 954-701-5094… keep trying him.

    • Kirk Bernard says:

      Well William, I’ve been dealing with this pain for over 3 years now and it don’t get any better. I have a inguinal hernia on my right side on Oct.31 2011. it was great for about 2 1/2 years than started with a stomach ache, followed by pain in my lower back after a bowel movement. well to make a long story shorter. Now I have red rashes on face an chest, a large lump on my left pelvis about the size of big egg, my right side is large but long. Your story sounds almost the way mine started. I think I finally got threw to the doctors that it’s the mesh. Funny I’ve been to 5 emergency rooms, general surgeons, urologist, and they all act like they never heard about mesh problems. Good luck to everyone that is going threw this bullshit. I’d love to get my hands on S.O.B.’s that ordered this to made. Country boy can survive! (ALL MESHED UP)

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