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Hernia Mesh Lawsuit Filed Against Atrium Medical Corporation

Hernia Mesh Lawsuit Filed Against Atrium Medical Corporation

By Dan C. Bolton and Farid Zakaria, Keller, Fishback & Jackson LLP

atrium proloop meshThe law firm of Keller, Fishback & Jackson LLP recently filed a lawsuit in California federal court on behalf of a forty-six year old man injured by a hernia mesh product. The lawsuit alleges claims of product liability, negligence, and fraud against Atrium Medical Corporation (Atrium), the mesh manufacturer, and seeks compensatory and punitive damages.  This is believed to be the first case in California filed against Atrium for one of its hernia mesh products.

The plaintiff, a resident of New Jersey, underwent double inguinal hernia repair in 2011 with the ProLoop, a surgical mesh made of a type of plastic called polypropylene.  He suffered serious complications after the surgery, including constant and excruciating pain in his groin, pelvic organ damage, nerve damage, the inability to have sexual intercourse, as well as anxiety and depression.  Despite undergoing additional surgery some 18 months later to remove the implants, today he still suffers from lasting health problems.

The ProLoop mesh is a non-absorbable three-dimensional plug composed of knitted rows of polypropylene with multiple protruding loops.  Polypropylene hernia mesh presents many of the same risks as transvaginal mesh, another dangerous medical device impacting thousands of women in the United States and currently the subject of nationwide litigation.  Both products have undergone minimal regulatory scrutiny under a legal framework that does not require the submission of safety and efficacy data to the Food and Drug Administration.

The lawsuit points out that Atrium’s warnings concerning ProLoop are grossly inadequate and violate the manufacturer’s duty to warn of the dangers of mesh.  In the Instructions for Use, Atrium states only that inflammation, infection, mechanical disruption, and adhesion are potential side effects.

Polypropylene hernia mesh is frequently used in hernia repair surgery, though it is not always necessary given the high likelihood of complications.  Despite relentless marketing by manufacturers, many doctors steer away from polypropylene mesh and use a mesh free procedure called the Shouldice technique to repair hernia.  The Shouldice technique has been used for decades and has low rates of failure.

Degrading Polypropylene

Degrading Polypropylene

Manufacturers have touted mesh for hernia repair as safe and effective, but published research has found high rates of serious complications.  One researcher observed there have been many “reports of various degrees of degradation … stress cracking and mesh shrinkage along with infection, chronic inflammation and the stimulation of sclerosis [hardening of tissue].”  The researcher concluded, “Based on available evidence the polypropylene used for surgical treatment of various structural defects is not inert after implantation in the human body.”

In fact, a debilitating consequence of hernia repair with mesh is inguinodynia, or chronic groin pain.  This condition results from the deformation of mesh following implantation, the persistent foreign body reaction to mesh, and nerve entrapment in the mesh.  The medical literature reports an extraordinarily high rate of chronic groin pain after hernia repair with mesh – in some reports approaching 50%, and even higher in others.  Moreover, as the mesh degrades in the human body, small flakes of polypropylene can lead to infection and irritation, and severe pain as the body tries to rid itself of the foreign material.

Despite the abundance of scientific and medical information published in the literature relating to the dangerous properties and serious risks of polypropylene mesh, the plaintiff asserts that the defendants have made a deliberate decision to ignore these dangers, to aggressively market the ProLoop, and to paint a misleading picture of its safety and efficacy in the product literature.

Dan C. Bolton is Of Counsel and Farid Zakaria is an associate in the Los Angeles office of Keller, Fishback & Jackson LLP.  The firm represents plaintiffs nationwide in pharmaceutical and medical device cases, including hernia and transvaginal mesh litigation.  Mr. Bolton oversees the pharmaceutical and medical device practice.  Mr. Zakaria has a background in molecular and cell biology.

26 Comments

  1. Richard M Howden(AMU) says:

    I hope this case is resolved in favor of the Plaintiff. Polypropylene is really bad stuff to put in the body but it keeps being used. Shrinking, twisting and breaking apart inside the body is consistent with what happened to me with another Hernia mesh made of the same material. I wish a Lawyer would have taken my case as I tried over and over again without success. My life as I knew it is gone and the one I have now is filled with pain and anxiety. The FDA just makes to much money from the manufacturers to care or worry about mesh victims. And unfortunately for the majority of us Hernia mesh victims, the Lawyers pick the easier cases to represent. I have yet to find a Lawyer that is willing to truly help a victim before figuring out how much they can make off of us. Anybody out there that can prove me wrong? Love to have his/her name and number!

    • Amy Reeves says:

      Richard….I know just how u feel….I have been trying for 6 months to find a lawyer/class action suit to take my case. Lawyers don’t want it because they claim that laws are there to protect Doctors, not patients, they would lose n lose money in the process. Class action suits find out im battling panniculitis, which is an infection, and they don’t want to represent a case that has infection. I don’t get that because what in the hell do they think this is gonna cause??? Its unbelievable. I have just resorted to the fact that Im turning my old Surgeon into the State Board and hopefully he will be fined or something… Im at my wits end, always depressed…Thanks for commenting….Amy Reeves

  2. Annie says:

    I have the monarch sling implant with complications on one of my hospital stays for infection a nurse treating me told me her brother developed a hernia after having surgery for an abdominal burn. She said the mesh it eroded through her brothers abdomen. She had to rush him into the hospital because it was literally sticking out of his stomach.this stuff is truly bad news. I hate that I have this in my body. I’m fighting to get it out.

  3. amy stone says:

    I have Marlex mesh made by Davol, and or Johnson and Johnson company. I had a routine abdominal hernia I had abnormal pain right away after surgery as a matter of fact there was an aide at the hospital, that told everyone I was a bad patient. Which I was mad about to begin with however it made me remember this problem started immediately following surgery. June 21, 2010 was my initial surgery, July 7th was my first ct scan. They found fluid or a seroma on the right side of my abdomen. I went back for a routine post op surgery appointment and my abdomen had swollen twice the size of normal. I asked the doctor, to please drain me as I was so uncomfortable. He said he would wait till Christmas and then go from there. I went back to my family doctor and asked him to find me a surgeon that would help me. He did and this doctor placed a drain and in the intial opening 1500 cc’s of black fluid came out everywhere. The drain stayed in until it started to smell and then we had to make an emergency trip to the surgeon and he put me right into surgery. Then I had drains on and off till, April of 2011 when I had a bowel obstructions. Which the doctors believed the mesh was growing into my bowels. Then in May I went to our local hospital my bp was 175/112 and they ignored me. Then my fiancé took me to a hospital one hour south of me and they put me right into emergency surgery. They again scooped infection out. They placed a wound vac in and I proceeded to run to the doctors office three to four times a week.. I have nerve entrapment, and chronic pain and infection, I hurt everyday and am unable to do my house hold chores let alone go shopping or carry my own groceries to the house. Today my doc took away my pain meds all together, so I am pretty much screwed. I still have a four inch opening with green drainage but I guess that isn’t important to them. I saw another doc who believed me and he asked the second surgen why he didn’t remove the mesh the last two times he had me on the operating table and why he placed drains in me with out being in a sterile environment. I guess it pissed him off so, long story short this hospital wants to be rid of me. they messed up my life and now they don’t want to see me and they are trying to make it look like I am a drug seeker which I wish were the case. My life stopped on June 21,2010 and these people don’t care.

    • Jane Akre says:

      Amy- you must get help immediately, infection and mesh near a bowel can mean perforation which is very dangerous is my understanding . Please do not delay and contact Bruce Rosenberg of the Meshoma Foundation, a non profit that is all about education and finding the proper doctor to treat you. Please do not delay… I’m so sorry about the pain meds as well, sounds like adding insult to injury. Bruce is also 954-701-5095. Thank you for writing…~ ja

    • Richard M Howden(AMU) says:

      Dear Amy, the worst thing about your story is that you are not alone. The damage done to you by the mesh is a litany of symptoms, infections that are first unexplained then ignored then indifference and abuse by the people you need to trust the most, your Doctors. Why is it that a victims of a mesh implant gone wrong are suddenly treated as pariah’s? The FDA ignores it’s own data base that clearly shows that there is damage being done by every make, model and use of mesh. “Suggested” protocol to have Doctors and Hospitals report defective and removed mesh products is ignored. Doctor’s routinely “run away’ from their mesh patients in case they may get sued. Doctors disbelieve their own patient’s complaints, pain and suffering as ‘your brain is doing this’ or ‘you are just trying to get more pain pills’ or ‘it’s just normal pain after surgery’. Meanwhile, as your story truly shows, the mesh is migrating and is cutting into organs and intestines. I’m not a Doctor but ‘black’ fluid coming out of your body in copious amounts would indicate to me that you are in serious trouble! Why in the name of God would a Dr. ignore this and try to explain it away unless he/she know exactly what is wrong and want no part of it. I have gone through it and so many of the mesh victims I have talked to over the past 6 1/2 years have been treated the same way. As Jane suggested, call my friend Bruce Rosenberg. He should be able to point you in the right direction. GET HELP NOW! Best Wishes and please let us know how you are doing………

    • Tara M says:

      U contracted biofilm…its in your blood

  4. tyler says:

    It’s sad to see so many people suffering from things like this Cuz of the negligent hiring of employees by atrium medical and operon staffing. I personally have someone close to me that got a job there. She was a recovering heroin addict. Then she got a job here and it started all over again. 50% of the employees are on drugs there is no pre employment drug screening done by operon. You have to be temp for operon for atleast 6 months working g for atrium befor you could even possibly be drug tested. All the employees know this and take full advantage. If you got there during break there is no food in sight you see half of them running to cars to shoot heroin. It’s sad that medical devices that could possibly save or take life are in the hands of such I irresponsible people

  5. john nix says:

    I had an inguinal hernia repaired w an Ultra Pro system by Ehticon in August 2012. My surgeon advised me of no possible options, alternative procedures or negative risks. Twenty two moths later after constant groin and leg pain, 30lb weight loss and loss of sexual function I decided to have the mesh removed. The surgeon that removed the mesh found that it had become ‘hard as a rock, was pressing on my femoral artery, shrinking and pulling tissues and nerves away’. Along with the mesh, he removed the inguinal, illiohypogastrc and genitofemoral nerves, All three had become in cased in scar. It has now been six months since mesh removal. The metalic taste in my mouth is gone, my skin no longer has a grey/green tint and the scar site is much less tender. However my groin, testicle and leg pain has intesified and by the end of the day I must use a cain to walk. It has made my life as a rancher impossible. My primary care physician and physical therapist are at a loss for how to move my rehab forward. Does any one out there know how to rehab this nightmarish condition? I need help as my livelihood and family responsibilities are at risk of being lost! I’d be most gratefull for any help.

    • Jane Akre says:

      What a nightmare John. I’m so sorry…. and how amazing the before and after picture. I strongly advise you to report this situation to the FDA and to the mesh manufacturer. I also suggest your doctor become proactive within his medical societies with what he has observed. This atrocity with hernia mesh should not be ignored another day! Bruce Rosenberg is the best source I have on hernia issues,,, reach him at 954-701-5094.. he is hard to reach sometimes but keep trying. He is hernia mesh injured and a wealth of information. I will write you privately or reach me at janeakre@meshnewsdesk.com

      • john nix says:

        Thank you Jane! Your response and advice is very much appreciated. I have an upcoming appointment with my physician and will follow up with your suggestions. Do you happen to have a data base for others that have had mesh removed? Particularly those with a longer history ( I’m six months post op ) and posotive outcome? It would be most helpful to hear what others may have done to mend from the removal of mesh. I’m in Colorado Springs and have not heard of anyone locally.

        Best Regards, John Nix

        • Jane Akre says:

          No there is not a database other than those comments here and on the Facebook page. I believe many people when they have their surgery, plan to get back to some semblance of regular life. I don’t blame them….. Did I give you Bruce Rosenberg’s number 954-701-5094 should be able to direct you. He is hernia mesh injured and an expert in mesh complications and docs…..

  6. Pamela says:

    Fishback, Keller and Jackson are not taking clients with Atrium hernia mesh outside of the state of California, false hope.

    Dan Bolton took me on as a client just to drop me as a client after going in front of a state judge.

    The state judge told him that only people who live in California could sue Atrium for mesh injuries, so anyone who does not live in California is just out of luck.

    If anyone knows of a law firm who is taking on Atrium hernia mesh cases and not the Atrium C-Qur hernia mesh please tell Jayne about how to get in touch with these law firms.

    People are suffering out here and they need help now!

  7. Sandra Aadland says:

    I was told by my surgeon I have MPATHY medical mini patch; no problem. I found out recently it was sold to another company – Coloplast and that there are lawsuits against this company but would like to know if anyone on this site has reported issues with it. Mine apparently failed as I have a rectecele, cystecele, entercele, but exam after exam from the surgeon who placed this and the TVTO I get “all’s clear.”

    In the room with the same surgeon was a colorectal surgeon/general surgeon as I have an abdominal hernia repair which started a nightmare – the surgeon said it is anatomically impossible for mesh to erode, break up, go near intestines/colon. I was flabbergasted as the reports I read tell me otherwise. Does anyone have any input?

    Mesh in four areas; pain just gets worse and I’m grateful for this site and those brave women who went ahead and paved the way to educate so many. Had I not found this site and those on FB, I’d just be another “chronic pain patient.” Which,to date, is the case. The education and hearing from others is absolutely priceless. And I’m especially interested in the effects of the coloplast mesh implanted in others. Thank you.

  8. William Mccollum says:

    I had a bilateral laparoscopic inguinal surgery in March 2008 and an exploratory surgeryin May 2008 at which time I had atack removed. I felt pain immediately sfter both surgeries and still do to this day. I have also hsd a urethralplasty from a stricture caused by medications. I have lost all my teeth and currently am in my 3rd pain clinic. I have lost the ability to be intimate. Ptsd anxiety depression. I have severe OIC and only have a bowel movement every 10 to 12 days. Am seeing a gyno urologist to help. Am currently on 12 seperate prescriptions. I was promised a much improved life with this surgery and am still waiting. Please help as I am desperate to get on eith my life. Ive had several bouts of homelessness. I would love nothing more than to have the financial security to explore other treatment options. 505 433 9029

  9. https://www.google.c says:

    i had laproscopic inguinal hernia surgey done w/ mesh, type w/ held, 13 1/2 months ago, i am 54, father of [3] teenagers, 2 months after the hernia surgery, i ended up in an emergency surgery, the mesh, infected, & wrapped around my bowel, this was after weeks of ERoom visits, the burning & pain down there, were beyond describing, hey would do a dye CT scan, give me IV fluids & antibiotics. & send me home, thingd got so bad i was on the floor in a ball praying to die, my wife rushed me to the hospital agian, there w/ a temp & bloodwork & another CT scan, i was rushed into surgey, the dr couldnt remove all the mesh but had to remove 8 inches of bowel, 39 staples later, & 10 days in the hosp. i was released still sick, i had dropped over 22 lbs, all iwas fed was ice chips, 24 hours later, i was home rolled up on the couch, w/ a temp. I couldn’t get up due to the pain, weakness & i felt like i was suffocating, my wife beggedme to call an ambulance, i couldnt get up, idk how but she got me to the car, & rushed me to a bigger well know hosp., at that time they told her i was given a 50/50 chance, they contemplated another surgery, but felt i was to weak, the 1st thing they did do was insert that nasty tube in my nose down my throat, [3] containers filled w/ blood & bile, i spent 11 mores days in ICU & critical care, i had to have a stent installed ,i lost the ability to urinate, then a bout w/ cellulitis, they cut my stomach & drained what they could, next followed [2] surgeries to remove infected inner sutures, i was left w/ large holes in my stomach, they had to be packed w/ a cloth & covered w/ gauze there & at home, i did this myself for months, i’ve been to the #5 urologist 6 times, he is done can no longer help me, states i have nerve damage, i live in a hell, a makeshift bedroom in the basement w/ hosp. urine bottles near me, i have leakage, inability to hold it at all, i haven’t been w/ my wife since [2] days before the surgery day. i’ve lost everything i owned, sold to live. i’ve been working since i was 10, now my wife works 2 jobs (bothers me so), all my life i was a fitness nut, now i am down so far, the pain,burning is so intense, i was a volunteer coach to the kids at the school my wife teaches at, for 10 yrs, now i cant leave long enough to watch them play, it’s been almost 14 months & nothing is much better, i am w/ a psychiatrist, if not for my kids i would quit, there is no describing this life, or lack of, & i find out i have no recourse, my wife doesn’t seem to understand how things went completely wrong, i grew up w/ little & said my kids never would, now bc of this they are, i did nothing wrong, i’ve beat 2 cancers, & took care of my 4 1/2 yr old daughter when she was diag. w/ ALL leukemia, i just feel lost & helpless, no pain meds touch this pain.

    • walt B says:

      i wrote the above comment of my ordeal

    • Jane Akre says:

      I am so sorry….. mesh near a bowel can be very dangerous so I hope you have some medical care that is competent. might you be able to consult with a mesh removal doc? Dr Kevin Petersen in Las Vegas is one….702-256-7616. Also contact patient advocate Bruce Rosenberg Text him at 954-701-5094. Again Im so sorry you are living this way…. why don’t doctors know about this outcome?

  10. Brian L says:

    Ive contacted numerous attorney’s & all keep telling me they are gonig to represent me I had the atrium pro loop mesh and plug put in & taken out & still suffer from pain every day ,do u have any suggestions ?

    • Jane Akre says:

      As you’ve probably heard Brian, the Physiomesh (Ethicon) and the Atrium C-Qur at the current hot meshes everyone wants to litigate. Ultimately it may expand to include others since they are all made of polypropylene…..Hollis advertises here…. have you tried them. I’m not a legal referral service and don’t know exactly what they are taking but I know they are onto this hernia mesh litigation in an aggressive way….. keep us posted on your progress. Anyone else want to step up and help Brian?

  11. Brian L says:

    Not going

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