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:

*Pain

*Infection

*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:

Pain

Infection

Recurrence

Adhesion

Obstruction

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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22 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

  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:

    Hello,
    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,
    Sue

    • 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
    312-259-2625
    Tjjburke@aol.com

  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?

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