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Lawsuits Scheduled for Ethicon’s Physiomesh Hernia Mesh

physiomesh-ethicon-hernia-recalledMesh Medical Device News Desk, October 25, 2016 ~  The first lawsuits have been scheduled for the Ethicon Physiomesh, a hernia mesh used for repairs. The hernia mesh has been removed from the global market after reports it degraded inside patients and did not function as intended.  

Medical professionals had until September 16, 2016 to return unused Physiomesh, hernia mesh, for a full refund after the product was recalled by its manufacturer, Ethicon, a division of Johnson & Johnson.  Ethicon issued a recall of Physiomesh last May after studies showed it failed when used in hernia surgeries when compared to other similar hernia meshes.

The mesh was used in laparoscopoic and ventral and inguinal hernia repair surgeries.

The voluntary recall was conducted by Ethicon, the U.S. Food and Drug Administration and its European counterparts.

Here is the Urgent: Field Safety Notice.  Here are the  Product Code numbers.

 

THE PROBLEMethicon-notice-on-physiomesh-recall

Two unpublished studies, one in the Danish Medical Registry and the other in the German Medical Registry, suggested its failure rate for laparoscopic ventral hernia surgeries were higher than the other meshes used on patients in these registries.

“The recurrence/reoperation rates (retrospectively after laparoscopic ventral hernia repair using Ethicon Physiomesh compositve Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”

Physiomesh is made of polypropylene but the studies found it broke down in its structure which can allow the hernia to recur or cause bacterial infections and swelling at the surgery site, requiring another surgery.  Ethicon suggests surgeons replace it with Proceed surgical mesh, Prolene, Prolene Soft, or Ultrapro mesh, all made by Ethicon.

Physiomesh was marketed after clearance under the FDA’s 510(k) process in April 2010, which does not require clinical trials for safety and efficacy.

Physiomesh is made of a flexibile composite mesh “composed of nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films. An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh.”

Ethicon developed Physiomesh Open the latest version of the type of mesh and it was introduced in 2014.  Both meshes were marketed following the fast tracked 510(k) approval process by the FDA. Physiomesh Open is not involved in this recall.

On its website Ethicon claims “ Physiomesh Open is built on the proven technology of the #1 selling tissue-separating mesh Open Flexible Composite Mesh, and optimized for open ventral hernia repair.”

 

LAWSUITS FILED

A number of lawsuits have already been filed.  Matthew Huff was implanted with Physiomesh in 2013 to repair a ventral hernia.  In July 2015, he developed severe abdominal pain, ever, chills, nausea and redness.  He was treated for an infection and two abscesses and an intestinal fistula.  His case is set for January 22, 2018  in the Southern District of Illinois.   Case No. 3:16-cv-00368.

Another product liability lawsuit was filed in the U.S. District Court Middle District of Florida September 22nd claims the mesh is defective and caused her persistent abdominal pain, diminished bowel motility and bowel obstruction.

Here is an adverse event report submitted to the FDA that says the mesh pulled away from he abdominal wall resulting in a second surgery.

In June 2012, Ethicon removed four transvaginal meshes from the market- Prolift, ProliftM+, TVT  Secur and Prosima Pelvic Floor Repair System.  The company said the removal was for business reasons.  ###

17 Comments

  1. Jerry M says:

    I had physiomesh in a ventral hernia repair 5 years ago since day one pain every day till now pee flow problems digestive problems sunk in side scar tissue ripping feelings and hearing it rip . nausea daily have fallen to floor in agony can’t perform sexyally as a man since this awful thing put in me. The list goes on and on I want compensated for this badly has ruined love life hobbies family fun financially distressed.

    • Ryan gerardo says:

      Have you been helped? I can direct you to some one who was able to help my mother? let me know if you still need assistance or you have been helped. I hope everything is going well.

      • Alex says:

        Man I had the Prolene Soft 3×6 put in me for a hernia repair 2 years ago. Constant pain and it has been taking me forever to get my stream flowing when I urinate I am glad I read this I am only 30 and was questioning if this was a beginning stage of getting older.

  2. Ryan says:

    In 2006 I was operated on by Dr. Kimberly Steele at Johns Hopkins Bayview. After surgery and at my check up my recovery did not go well.. as I was introduced to burning .. stabbing and life changing groin pain that ten years later has become chronic especially when sitting down. At my check up I was in so much pain I fainted in my surgeons office who said all checks out (aka for I have no idea what’s going on.. it’s not my fault ), called me crazy and pushed me off to the ER.

    I’ve since been to other surgeons who said I am the unlucky ones and sorry. How many hernia repaired unlucky very active virile men are there out there…thousands … hundreds of thousands?

    Overall at 30 I just wanted to continue lifting weights(ha never did that again after surgery) so I trusted my healthy body to these people and mesh corporations who obviously do not care about anything more then making money!!!!

    Avoid any and all type of hernia surgery unless it’s life threatening … otherwise if your a very active virile man who gets this guinea pig surgery done you might just be introduced to the same life changing horrifying pain for the rest of your life. It can not be removed as it is fused and becomes a part of you constantly hitting your inguinsl nerve that sends pain to your leg.. groin area… testicles and causes pain during sex. 🙁

    • Ryan gerardo says:

      Have you been helped? I can direct you to some one who was able to help my mother? let me know if you still need assistance or you have been helped. I hope everything is going well.

      • Janine says:

        Help yes 3/21/2014 umbilical hernia repaired with ethicon ultrapro plug mesh.
        3/31 rushed to the ER with vomiting and pain every 20 mins, ct scan showed blockage, sent by ambulance to hospital that performed the umbilical hernia repair. At approx 5 a.m. (now April 1) doc came while getting NG tube in said prep her for surgery by 11:30 a.m. I was in surgery.
        when I woke I was cut from sternum to crotch with 27 Staples holding me together. the mesh had adhered to my small bowels and he had to remove all of the product and 6 to 8 in of my small bowel. I wish I could say it ended there, 7 Days Later went home still with staples, 5 days after that still with staples rust again to the hospital with vomiting and pain every 20 minutes spent 16 days in the hospital because of secondary inflammation at the site with an NG tube down my nose and a PICC line in my arm and I wish I could say it ended there….
        a week in july over the 4th because of iinflammation again with a NG tube and IV nutrients I wish I could say it ended there…
        Feb/2015 after complaining about pain in my lower abdomen CT scan was performed by the VA Hospital which showed two hernias along the sight of the incision, another surgery required when they got in they found 4 hernias and said “it looked like Swiss cheese”. I am still having problems to this day with digestive/bowels issues.
        Sooo you got someone you think can help me?

    • Kym says:

      Hi, I came across your post and I’m going through same situation with mesh. Not sure what type of mesh was used but, Since first my life has been he’ll. I’ve had mesh put in for ventral hernia, inguinal, and diastasis recti with bladder pushing through. So, mesh was put in and taken out. Repaired 8 times and now I have biologic mesh from public area to belly button. It has been hell, the mesh in my groin is still there an I was same pain when sitting. Started when my colon was perforated after hysterectomy in 2012. This all has been going on since, my recent last surgery March 2017. So much pain I’m also having problems in the sex department. Married 14 yrs….. and I feel like I’m robbing my husband of a sex. This mesh has ruined my life in so many ways. I was also recently diagnosed with psoriatic arthritis. I’m just falling apart at 38yrs old. I’m really not sure what type exactly was used. I do know it was synthetic mesh in the beginning. They want me to pay for my medical records (pertinent records). Records I don’t need are free and they want $200.00 for the ones I need. My question is what kind of mesh did they end up using in the end? What other symptoms are you having?

  3. dorisine k says:

    I have had hernia repair twice and I need it again. Before my doctor passed last year, he suggested that I needed hernia repair again, that will be my third time.

  4. chris p says:

    i had a hernia repair back in 2012 with dr gorrello in wayne memorial hospital and was implanted with physio mesh. while waiting for my follow up i was i massive pain the whole time this mesh was in me later i went to have my follow up and he told me the hurnia came back and will need another operation i thought it was him that didnt know what he was doing so i cursed him off and said i was suing him tofind out that it was the meshes fault and not him…3 months later i had another operation at the same hospital with dr lencuski* and was implanted with peritex mesh and feel the same pains i did with the 1st one and no dr wants to remove it because its fused to my body so i cant lift the things id think would be no problem lifting now are a problem… i cant walk for a long time without feeling pains nor can i sit in the same position for a long time with out feeling the same pains… this will for ever change my life wish i kept the hernia instead of “correcting” it. good luck to all the victims out there!

    • Chris Porter says:

      Today I found out that the physio mesh was never removed I’m going to get a ultrasound to see wether the perietex mesh was placed over the physio mesh

  5. Mark Forsling says:

    I had post operative inguinal hernia pain for years. Last year, I discovered an experienced surgeon who removed the mesh and closed the hernia without using mesh. I recommend it. He is Dr. Bruce Ramshaw at the Graduate School of Medicine in Knoxville, Tennessee.

    • William G says:

      I need a doctor to remove the plug that I have had since August 15, 2013. It has caused me to have two revised surgeries due to the complications of the mesh plug. The plug caused me to lose a part of my toe, because of the blockage in both of my legs. The doctor that performed the surgery refused to corporate with me when I asked him questions a about the implant. I didn’t know that they have an expiration date. My plug expires in 2018. I left a message for the doctor to call me with expiration date, but there has been no response. I need revised surgery for an inguinal hernia. ASAP!!!!!!

  6. Scott K says:

    Have had the same incisional hernia repaired 4 times with the 4th being Ethicon Pysiomesh in 2015. Spent the next 15 months with an infection and recurrent hernia. Had surgery performed on 10/08/17 to remove the “grossly infected mesh” (surgeon’s words). As consequences, also had to remove my appendix and cut out a portion of my small bowel due to the issue. Not terribly happy about it, but had no choice. One of the antibiotics used to try to co.bat the infection cost $10,000 per month…

  7. Joylene says:

    I had hernia repair done in 2013, I sweat profusely, headache,pain so bad that feels like my intestines are twisting and everything from left side moves to the right where my mesh is, Sex is painful, I have to push on my stomach just to pee, I also dealing with Low core body temperatures, WBC was 20! NO surgeon will take it out,even though i have severe scar tissue and staples where there shouldn’t BE, I feel a ripping, tearing, its worse whenever I bend down. I’VE been told its in my head,Sorry nothing we can do for you, I have been dealing with this pain since day 1 of the repair, the surgeon did laparoscopy through my bellybutton which oozes and gets crusty one minute my bellybutton its MRSA,and then its staph. I was on an antibiotic and felt awesome til ran out and my WBC skyrocketed it to 20, has anyone experiencing mood changes? I’m like NOT myself, old me is GONE, 41 now and have NO LIFE. I have a mesh called Ultra Pro. My symptoms are Severe Pain,groin area,lower right (where hernia mesh supposed to be) Severe headaches,sweating profusely, Pressure in bladder while pushing stomach to start to pee and continue to push til I empty or feel like it is, my lower right abdominal is Hot, One minute feels like my body is having allergic reaction, the next flu like symptoms, Doctors don’t CARE,neither do surgeons I’VE seen 4. ONLY surgeon that takes out hernia meshes is in Nevada and he charges $10,000 in cash, Ive had intestinal problems from hurts to pass stool and a ulcer that bleeds,but they claim its NOT related to my mesh. I have severe scar tissue,and have had 6 CTscans yet can’t see the mesh just scar tissue. I’m always nauseated and times I throw up in my mouth and goes back down again,my teeth are losing enamel and have had several pulled. I’m tired,have NO life, and ended a relationship because of everything going on.I also feel wetness inside my stomach and pain also goes to lower left, upper left abdominal as well, I read someone’s message about getting your medical records, if they (hospital) offer online services to review your medical notes,blood tests,imaging etc YOU CAN go online and PRINT it out. The meshes are easier for surgeons,learning how to repair a hernia without mesh is obviously a burden on them,and Us patients suffer as a result. My body is fighting itself, and its winning and I’m losing. My hernia repair was worst possible one,can move,perforate other organs, I’VE been treated for UTI that has Ecoli in my urine 4 times and urine stinks so bad , Cdiff, and I’m diabetic and NO insulin lowers my numbers, body is fighting itself and medications as well.

    • Jane Akre says:

      Joylene-

      You sound very sick. please let me know where you are located so we might find someone to help you. Stool anywhere else in the body is not sustainable. I hope you have a lawsuit as well. You can write me privately janeakre@meshnewsdesk.com

  8. Victoria says:

    My health was very good until I became injured on the job with an inguinal and abdominal hernia. One day I just couldn’t walk do to the pain of trying to lift my legs to walk. It took three months of numerous scans, ex-rays, being told I was crazy before they found the inguinal hernia, another year before the abdominal hernia was discovered even though I was animant about there being a second one. In 2011 an Ethicon Mesh was implanted to fix my Inguinal hernia. Every thing seemed fine but the pain never subsided exspecially after I did not want to take anymore Oxy’s. It was all down hill from there! I couldn’t eat, drink, as it caused this cycle of bloating, severe pain, along with vomiting. I ended up losing 80 pounds, my flesh hung off my bones, couldn’t walk nor use the bathroom without assistance. Every month I would be in the hospital because of dehydration, because my body couldn’t even keep water down. I prayed and prayed the pain was every day of every minute, at which point I was being deprived of sleep. One night the thought of ending my life creep in and all I could do was pray, and call my sisters for help. For once in my whole episodeI felt a clarity that I had not had before, and was able to advocate and find a doctor who listened and found pain management that finally gave me some relief. Every four months I get cortisone injections which helps me sit, stand and walk much longer. Plus it helps with all the abdominal discomforts along with the Lyrica I take to calm my nerve damage. The pain is manageable because of the treatments, and because I spend time figuring out the triggers, because there are a lot of them. I’ve recently been moving around a lot, and believe me it can still get rough, causing me to takeaway rest for a few days. No more surgeries for me, I know what I have, and it’s a part of me.

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