Hernia Mesh Complications – Is the FDA Watching? Part I

Nov 28th, 2012 | By | Category: Hernia Mesh Injuries, Medical News

Removed hernia mesh plug, Dr. Kevin Peterson

November 28, 2012 ~ The U.S. Food and Drug Administration (FDA) has been updating pages on mesh used for hernia repair.

Unlike transvaginal mesh, also made of plastic polypropylene, there is no Health Notification or Safety Warning on hernia mesh. That means there are no active lawsuits involving hernia mesh, but injuries are coming into the agency nonetheless.

For example in its updated November 20, page, the FDA reports it has received reports of complications associated with hernia mesh such as:

*Adverse reactions to the mesh

*Adhesions (when loops of the intestines adhere to the mesh or each other)

*Injuries to nearby organs, nerves or blood vessels

*Additional complications with or without mesh can include infection, chronic pain and hernia recurrence.

“Since the 1990s, there has been an increase in mesh-based hernia repairs – by 2000 non-mesh repairs represented less than 10 percent of groin hernia repair techniques.”

That may explain why, at least anecdotally, there appears to be an increase in hernia mesh complications. MDND receives calls frequently from patients who have a diminished quality of life after a surgical mesh implant for hernia repair.   See Kristina Graham’s story in Part II (here).

This woman, who is represented by a lawyer and can’t be identified, wrote MDND to say both she and her husband  have Atrium CQUR hernia mesh, which is a polypropylene mesh coated with “Omega 3  Bioabsorbably Oil Fatty Acid (03FA). See product here.

“Its been 11 months and my husband is still suffering. One implant, one removal, one more implant and a massive infection which nearly took his life. now needs a third very difficult surgery to remove the second implant. Loss of over 96,000 a year income form our business, loss of life as he knew it, constant pain. Its not a pretty picture.”

Complications can include pain, nerve entrapment, reduced movement, and a foreign object reaction that can include fever, swelling, and general malaise.

Hernia mesh, WikiCommons

Synthetic Hernia Mesh

Mesh is either synthetic – a knitted material or non-knitted sheet. It may be absorbable, or non-absorbable or a combination of both. Non-absorbable mesh, which is mostly synthetic, will stay in the body indefinitely. It is a permanent implant and difficult to remove.

Animal-Derived Hernia Mesh

Animal-derived mesh can be made from animal tissue, such as the intestine or skin of a pig (porcine) or cow (bovine) that is processed and sterilized. Animal-derived mesh is absorbable.

Over time, absorbable mesh will degrade and lose strength while new tissue growth takes over to strengthen the repair.

With or Without Mesh  – Hernia Repair Complications include:



*Hernia recurrence

*Tissue that stick together (adhesion)

*Blockage of large or small intestine (obstruction)

* Bleeding

*Abnormal connection between organs, vessels, or intestines (fistulas)

*Fluid build-up at the surgical site (seroma) and perforation or a hold in neighboring organs or tissues

WITH Mesh:

The FDA says it has received reports of:






Perforation which can lead to sepsis or poisoning of the blood stream and is potentially fatal

Recalled Hernia Mesh

The FDA update says “Most of the complications reported to us so far have been associated with mesh products that have been recalled and are no longer on the market.

This is perplexing because besides the largest hernia mesh recall for Kugel mesh, there have been very few recalls of hernia mesh with the exception of a few manufacturing lots recalled over mislabeling and/or sterility issues.

More than 2,000 lawsuits were filed against C.R. Bard, maker of the Composix Kugel Mesh hernia patch which was recalled three times between 2005 and 2007 because the memory ring broke and could cause serious perforations. The company redesigned the Kugel patch and reintroduced it in the market through the 510(k) approval process. The FDA Kugel mesh recall December 2004 is here.  The 2005 Kugel mesh recall is here.

Besides Kugel, the Proceed surgical mesh had Ethicon recall 18,270 lots in January 2006 when the polypropylene delaminated from the mesh, opening up the patient to the possibility of fissures and adhesions.
The FDA report is here.

The only other large hernia mesh recall was in September 2005 by LifeCell Corporation over its AlloDerm mesh. It was determined that about one-quarter of those implanted with the donated human/cadaver skin mesh had complications including infection and rejection.

The remainder of mesh recalls have been limited to small numbers of mesh due to sterility or mislabels.

Part II continues here.

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53 Comments to “Hernia Mesh Complications – Is the FDA Watching? Part I”

  1. robert carson says:

    i had my hernia dun on dec 2012 and i have had pian and hove a hole in my tunmmy i has take over mt live just now and i am not getting the help i need i cant go out a lot now i cant sleep with my wife becuse i am i so much pian

    • Marcus hytche says:

      I received my surgery in November 12 & have the same problem. Wish I knew what to do. This 24/7 pain sucks

      • Jane Akre says:

        Please contact Bruce Rosenberg who is a hernia mesh injured researcher. He can help you with your road to health. brosenberg1@bellsouth.net. Thank you for writing.

        • Clara Aragon says:

          Back in August 2006. I had a right inguinal hernia.I had a Kugel patch.then in October of 2010. Ihad a left inguinal hernia and a left femoral hernia. That involved a perfix mesh plug. Ever since I had those surgeries I have had bladder prolapse. Pain with intercourse. Throbbing.infections. last march got jaundice. They also maid comments about me. But negative results. But my bilirubn levels were high. I had a liver biopsy. I never really got answers .I also lost weight. They said I was anerexic which I am not and have never been. Should I be concerned .please help.sincerely Clara Aragon.

          • Jane Akre says:

            Yes Clara, you should be concerned. You cannot continue to lose weight and have infections. Please contact Bruce Rosenberg of the Meshoma Foundation 954-701-5094 who himself is injured from hernia mesh but has devoted his time to mesh research and information… go to brosenberg1@bellsouth.net. He is sometimes difficult to reach but keep trying. He will ask if you have all of your medical records – which is advisable in any case. Pls let us know how you do and what your next step is.. please reach out to Bruce… unfortunately few doctors seem to be willing and able to recognize what you are going thru as possibly mesh-related. ~ ja

    • Keith Robinson says:

      I have had at least six inguinal hernia repair surgeries in the same place, the last one was in 2009, plus Fistulae repair. I had severe abdominal pain, vomiting, infection, and developed a clotting disorder due to the infection. I nearly died. I had many emergency room visits and hospital stays as well. I have never been compensated for all my pain and suffering, and the legal system nor the FDA could careless.

  2. Dee says:

    I have past incidences of my body rejecting foreign materials placed in my body. Now that I have a hernia they want to implant a synthetic mesh, I have repeatedly asked for biologic, but they all refuse to use biologic and refuse suturing technique. Why should patients suffer with rejecting or migrating mesh products; we should have more treatment alternatives available to us. I have no choice but to have this surgery and have decided that if I have complications I will seek self euthanasia than to be gutted, disfigured and have worse chronic pain than before.

  3. Sue Hahn says:

    I would like to know when there will be a recall of: Atrium Pro Loop Mesh and Plug for hernia repair???? They have an FDA unsanitary letter, they have made my life a living hell!!!! Three years later and now I am going to have it removed. PLEASE email me if you had this brand used on your Inguinal Hernia or other hernia areas. They should NOT get away with this!!!
    Thank you,

    • Marlene says:

      Hi Sue,
      My 21 year old son had a hernia repair 3 years ago and now it appears there is a reoccurrence as he now living out of state and telling me that it is bulging out of his stomach. I told him he needs to get it looked at, but I was wondering if you ever found out about any recalls for the Proloop Mesh as that is what is in his medical records. You can call me at 941-286-0079 if it is easier. Thanks so much. Marlene

    • Cindy says:

      I had to have the mesh removed and now I am worse I have ever than before. My advise is don’t do it I was the worst surgery I ever had. I was bedridden for a year I was so swollen I couldn’t stand up for more than five minutes without excruciating pain. My doctor had only done three mesh removals. He assured me that it would help but it only made things worse. Ask your doctor how many he has done before get a second opinion even. I wish you better luck than me.

  4. Kim says:

    Hello , Im here to say I have a kugel bard mesh in me since 2009 , and I have had to have it removed and replaced with the same mesh in 2011 and still this day which matter fact I had surgery Feb 2014- and was told the mesh is recalled but they wont remove it right now bc its still intact and its a higher risk surgery , but was told by the second opinon doctor who did my surgery in Feb if the pain keeps up he will remove it and repair the hernia some other way , but as of right now im still having pain it still buldges and it hurts more some days than other , and im only 24 yrs old with no kids not married …. but some day I want to be married and have kids , but I dont want to be having all this pain for the rest of my life .

    • Jane Akre says:

      Hi Kim- You may want to talk to Bruce Rosenberg of the Meshoma Foundation to get a second opinion… He is very knowledgeable and reasonable…. 954-701-5094. He will offer you a balanced opinion…..

  5. cool tan says:

    my first surgery was in 2007 where a prolene mesh was used I was having lots of pain the second was in2009 on both side left and right a mesh plug was used on one side and other side it was just clean an then in 2013 I did again on left side that’s 4 surgeries an I am still having lot of pains on both sides don’t know what to do

  6. 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

  7. penny pinkham says:

    In 2009 I had abdominal. Mesh surgery due to an abdominal mass no true hernia. (Bovine) I have had several episodes of the incision opening up draining then after antibiotics it heals. After a year of pain I finally found a Dr to see me he said he would not touch it. He did do a scan & found my gallbladder was disfunctional.4-2014. I had the gallbladder removed to no email the pain is still there. In 8-2014 I had an Ercp due to enlarged bile duct. Still no relief it feels like broken glass and I can not turn from side to side it feels like I am ripping my self. I also if I turn from side to side I feel something flip and I can’t breath or move until it flips back.. Please Help me.

  8. June Tarkington says:

    Had hernia repair in may 2011. Have been having trouble since then with severe pain. Doctor said nothing he could do for me. Have had another surgery since and pain is back and worse. What can I do?

    • Jane Akre says:

      June- we always sent new hernia injury folks to Bruce Rosenberg 954-701-5094 who himself is hernia mesh injured. He runs a nonprofit organization and is very knowledgeable . It’s hard to believe a doctors says there is nothing they can do for you since they did something to you! Call him and keep trying… thank you! ~ ja (and I’m sorry).

  9. johnetta hurley says:

    Jane, I tried contacting Bruce and could nit get a hold of him. Is there another way or another person to contact?

  10. Nick Perri says:

    Has anyone had any luck getting a lawyer to handle partiex mesh repairs please email me I had small bowel blockage stomach pain all the same symptoms as the other that were recalled had to have surgery because of blockage was in hospital for 23 days lost over 50 lbs I can’t find anyone so please if you know of a lawyer email at aug10568@aol.com

  11. Shawntell says:

    I had a bilateral hernia repair done in 2008 and immediately experienced pain unlike you have never had before. I asked if the mesh could be removed, only to be told to wait a year for adjustment to the mesh. After a year in a half and many doctors and specialist later I started going to a palliative care doctor. I was told by him that Surgery for me was never going to be an option. If it was Not removed right away it would never be removed. The doctor was wrong, the mesh had already started to grow into my organs and it would do far to much damage to remove it. And that is when I tried to talk to a lawyer and was told it was to late I should have seen one as soon as my surgery was complete they needed more time to look into it. Obviously Michigan is a state where you have 2 years then you are screwed.
    So basically the doctors kept me running around for a year and a half telling me my life will get better. And the truth is now I will be on nerve blockers and pain pills for the rest of my life, and still not live a full life. I still cant exercise or have an active sex life. so whatever this mesh is sucks and has ruined my life.
    So if you have a choice do not get this surgery, and if you have to have it NOT in Michigan.
    I now have another hernia thats in my umbilical area that will stay there until it kills me… Good luck everyone.

    • John says:

      Can you possibly contact me? I’m a male, in Michigan, similar situation. Been a year and a half and getting the runaround from lawyers and doctors because the mesh hasn’t been recalled. theonlyjohnstevenson@Yahoo.com

      • Jane Akre says:

        There are few recalls so that is not the issue. Bruce Rosenberg, is hard to reach but an expert in hernia mesh issues, he has a nonprofit and is mesh injured. 954-701-5094.

      • Jane Akre says:

        Please contact Bruce Rosenberg concerning hernia mesh injuries. There are few recalls, mesh is still on the market. 954-701-5094.

  12. Dennis Smith says:

    Hi ,In 2010 my mother had hernia surgery where mesh was used.seemed to be ok untill about 1 1/2 years ago she started having sever abdominal pains . After numerous trips to the doctors it was found to be the mesh had disintergrated and moved down to her liver and next to her painkrious. She was referred to the Mayo clinic in Phoenix. They after numerous trips to Phoenix said it was to dangerous to remove and if they tried she wouldn’t survive .now all she can do is sit on the couch in a drug induced state and any movement she cries out in pain.I have called several lawyers they wont return my calls .My mother is 70 years old and this is noway for her to spend her golden years , please can anyone help

    • Jane Akre says:

      What kind of mesh does she have? Do you have all of her medical records? I’m so sorry to hear about your mother….. please answer… I cannot believe there are not some lawyers willing to take on this issue!

  13. Carla says:

    I have a colostomy and had hernia repair with mesh near/on my stoma several years ago. Prior to that surgery I had never experienced a small intestine obstruction and since then I have been hospitalized 20 times with obstructions. It is very painful. I love to travel but MUST be close to a hospital at all times. Has anyone else experienced these problems after mesh surgery for hernia repair? The last hospitalization took place in LA at Cedar Sinai and the surgeon said he believes the mesh may be the culprit.

    • Jane Akre says:

      Thanks for writing Carla, I have heard of obstructions of course with mesh. Bruce Rosenberg 954-701-5094 is an expert in hernia mesh complications. He is hard to reach but worth it. Thank you.

      • Carla says:

        Thanks, Jane. I will do my best to get I touch with him. It is so weird because I never thought of the mesh being the problem and now it makes sense on so many levels. I knew that surgery had kicked off the obstructions but didn’t equate the mesh. Duh?????

  14. Elaine says:

    March of 2014 I had my colon resectioned. The surgery seemed to have gone well, however I developed a large incisional hernai and March 18 of this year I had a second surgery to repair my abdomen. The doctor used a Bard Davol propylene mesh and Ihad 2 drains for 8 weeks in my lower abdomen post surgery. To date I still look as if I’m six months pregnant. I went to my surgeon and he said I need a tummy tuck because the swelling was a layer of fat. So he sent me to a plastic surgeon who said he believed I had a seroma. Yes I do. It has been drained twice now at the hospital. Still my abdomen remains terribly disfigured. Previously my stomach was flat and now I look six months pregnant and must wear a heavy gauge girdle to control the huge protrusion. I have constant pain near my umbilical area on the left with hard lumps my surgeon claims is scar tissue. Will this swelling ever go down or is it fat? I walk 45 minutes to 1 hour each day, but my disfigurement has not receded. I’m so sad about. Will the swelling ever go down?

  15. Frank Ruiz says:

    Had ventral hernia laparoscopic surgery,it went bad and ended up open.surgery so I ask should prolene mesh have been used with out somekind of barrier,or because I had open.surgery no mesh should of been used

  16. Frank Ruiz says:

    I had ventral hernia ,because lower intestine was punctured should mesh have been used because of enterotomy was performed ,should some kind of.a barrier to protect.the intestines.I encounter mesh.complications and.fistula infections.are there other surgical manipulations that might of been done.is there anything else to mitigate the issue that could have used between the abdominal wall and the mesh.

  17. ive been here before and had some negative comments..but i have a Johnson and Johnson phsio mesh for umbilical hernia ..scar tissue you can feel under skin…sex drive is gone hurts in area. when orgasm..stabbing shooting pain.canvfeel tissues tear if working using abdominal muscles peecpressure is gone sliw digestive now ..i got into pain management today.after 4years of complaining..was given 10 mg oxycontin. 4 a day..i break with pain after rwo hours..is anyone else receiving. pain management and if so.what are you getting prescribed..i feel i need more dose or higher mgs to actually not have it bother me so much….and has anyone found a lawyer for us guys yet??? with no help ..we suffer and our manly parts quickly turn into antiques….id like to get up pee ..crap..andchave a hard on again..im 46. my penis is 86. jow tjx mesh,,

    • Mitch says:

      Hi Jerry I to had a umbilical hernia sugery in Jan 2010 it left me disabled for the rest of my life I have been to every dr and specialists possible they put in a juggle mesh I now have pain were the mesh is into my right testical behind testical down to just above knee if I walk to far lift to much like my grandkids that is 2 or 20 lbs the pain goes through my hip in to the lower back the Drs said that the mesh and scar tissue that forms due to mesh entrapped the nerves basically the mesh relies on scar tissue to make it stronger and that entrapped the nerves it has left me on pain meds and lucky if I can walk to mail box its 800 ft away it’s sad so if any body finds a attorney to take a cas let me know.

  18. Michael Bentley ( UK ) says:

    Hi; I had a Ventral Hernia; 13 months ago; After Laproscopic Colon Resection / Tumor Removal; I am now in severe pain plus nasuea, +++ It was An 8″ x 7″ COVIDIEN “PARIETEX” Mesh Inserted, Just had a CT Scan, to check if it has Failed?? I am a very Fit elder Tennis Player, 5′ 10″ ( now ) 150lbs, ( lost 5 lbs this year )

    I would welcome any Info on the Covidien Pariertex; Ventral Hernia Large Patch; I am in the UK, but very Keen for Feedback; You can publiosh my E-mail address for assistance; Thanks; Michael B ccmcargroup@aol.com

    • Jane Akre says:

      Please check with Bruce Rosenberg 954-701-5094. he is mesh injured and a wealth of info about docs and lawyers…. he has a nonprofit that focuses on patient education.

  19. Amy Reeves says:

    I had a hernia repair 6-13-14 and they used an Atrium Mesh. I was in pain and in January of 2015, another doctor did a ctscan w contrast and thought he and the radiologist saw a huge blood clot in my stomach. It was actually the atrium mesh that my old Surgeon had used that was now all balled up and intertwined w my bowels. It had adhered to my bowels n my colon. On Aug 6, 2015 I had to have the hernia repair redone. My new Surgeon tried to remove as much of the old mesh as he could but he couldn’t get it all out or he would’ve caused me more damage. I have pain every day still and panniculitus infection due to the Atrium mesh. Lawyers don’t want to touch this here in Texas and when I go to a class action law suit….they don’t want it because of the infection the old mesh has caused. I feel like this mesh and provider have taken years off my life and im just sitting back waiting for Sepsis to set in….its scary esp since I have a special needs child n we have no family really. Im at a loss, I believe not only the mesh company should pay but so should the Surgeon n Hospital. I don’t know where else to turn anymore!!! If anyone can advise, please do so I can seek help!!!

  20. Denyce Dauwalder says:

    need to know ALL the brands that were recalled

  21. Helena Obbink says:

    In 2001, I had a total mesh pelvic floor repair. I have my surgery records that show a 12 X 12 sheet of J&J Ethicon Prolene Mesh was used. I have the abstract of my surgery. They cut the mesh into strips and then sew what looks like a horse halter and then they dissect you and place it in the pelvic floor. I came out of recovery screaming I was in so much pain. Doctor told me same thing everyone else hears, you will get used to it. Well to this day I am in chronic pain and have been on pain medications since that surgery. So here we are almost 15 years later and I have no quality of life. I developed fibromyalgia shortly after surgery, then diagnosed with SLE Lupus in 2009. The doctors have a hard time medicating me because I have developed chemical sensitivities. I developed skin cancers after that surgery. One removed on my forehead had to be sutured and guess what? My body spit out every internal dissolving stitch! Went to plastic surgeon for scar revision and same thing happened. I live everyday with the sensation that I have a big splinter under my fingernail. My insides are constantly trembling and this once healthy women is now a sick invalid. No one should take another man’s life from them.

    • Jane Akre says:

      Helena- Sounds like you had a mesh custom cut and fitted to you… how horrible. Tell us the name of the doc if you would….your reports of fibromyalgia and lupus are experienced by others as well as chemical sensitivities. Some day we may understand that bodies do not do well with a lot of mesh in them, at least some bodies. But which ones? Shouldn’t we answer that question before continuing to use it? Have you had any attempted revisions?

  22. Helena Obbink says:

    Dr. R. Hoellrich has since passed away (2011). I asked for him to remove the mesh in 2003 but he said ‘NO’ that the mesh was already ‘entrenched’ in my body and it would be a mess to remove. I really don’t think he had a clue as to what he had done. I have not had any revisions. I just saw Dr. Megan Cavavaugh in Portland, OR this past Nov 2015, to see if she could remove it. She told me that there were only a couple hundred of these procedures done in Oregon and that it was a bad application. She is supposed to be well versed in the subject of mesh and I guess has written papers on it. I asked her to remove the mesh and she choked up and said there was nothing she could do for me. She said ‘don’t let anyone touch it and don’t have any more surgeries in your pelvic area’. I should add that I had a total colectomy in 2007 by Dr. H as my colon stopped working and I have an ileo-rectal anastomosis so I don’t wear a bag. So counting my vaginal hysterectomy in 1988, I’ve had 3 major surgeries in my pelvic area. I bounced right back after my hysterectomy and oddly enough bounced back after my colectomy. Still am dealing with the never ending pain from the mesh surgery. At least I’m glad I’m not losing my mind and at the same time, I’m sad that there are others like me.

    • Michael BENTLEY says:


  23. Michael BENTLEY says:


  24. Kym Salas says:

    I had a bilateral masctomy with a tram flap reconstruction. Has anyone had this? I’ve had five surgery’s to remove mesh and now have a Dr. Appt Wed because I look eight months pregnant and my skin is so thin sores are developing on my belly. I take morphine daily for pain. I’m 56 yrs old and feel like I’m 90. I had to retire medically my sex life is gone. Thank God my husband has stayed with me thru this. Can in suggest an attorney who might handle my case. Or is there any patient on this forum with the same issue after this procedure . please contact me at mksalas@yahoo.com.

    • Jane Akre says:

      Bruce Rosenberg may have some answers for you. 954-701-5094. He is hernia mesh injured and knows about tram flap repairs.

  25. James Cole says:

    Had C-Qur put in for double bilateral hernias repair July 19, 2013, within about 6 months I started having severe pelvic area & stomach pain,January 2,2016 was admitted to JFK Hospital for Hematoma /Absess, severe pain in stomach, being told this mesh can Not be removed by the Surgeon who implanted the mesh Doctor Jesus Jeminez. Need mesh out, jkcwizard@aol.com

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