Counterfeit Polypropylene Mesh Marketed as Bard Surgical Mesh: FDA

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The FDA is warning that health care professionals may have been sold a counterfeit surgical mesh under the C.R. Bard brand name, which could put patients in danger.

The counterfeit surgical mesh warning, issued on March 11, alerts health care providers and consumers that someone is distributing fake polypropylene mesh products. The FDA is uncertain whether these copycats are safe to use on patients, as they have not been evaluated or approved by the agency. The FDA warns that it does not know if the patches are durable or even sterile.

The counterfeit surgical products have been falsely sold under the C.R. Bard/Davol brand name in a variety of sizes. The FDA has confirmed that the meshes are not manufactured by C.R. Bard, but did not release any information on who might be producing or selling the fake medical devices or whether anyone had been injured by a counterfeit mesh.

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Health care providers should be on the lookout for Bard Flat Mesh 2” x 4” sheets with lot numbers 48HVS036 and 43APD007; 10” x 14” sheets with lot numbers HUSD0629 and HURL0336; 3” x 6” sheets with lot numbers 43HPD027, 43HPD032, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011 and 43IPD038; 6” x 6” sheets with lot number 43FQD327.

Surgical mesh is used by surgeons to shore up weakened soft tissue in the body to prevent hernias or rupturing. The meshes being counterfeited are sold as flat sheets of polypropylene.

Davol, a subsidiary of C.R. Bard, Inc. currently faces a number of legal problems over some of their real surgical mesh products. More than 1,000 Kugel Hernia Mesh lawsuits have been filed against the companies by individuals who say they suffered injuries due to defective meshes. At least three separate Kugel hernia patch recalls were issued by Bard and Davol between December 2005 and January 2007 for different types of hernia mesh, which have been associated with problems like intestinal pain, bowel perforation, intestinal fistula and additional surgery to remove the mesh. All of the lawsuits involve allegations that plaintiffs suffered severe injuries and potentially life-threatening complications from hernia surgery repairs caused by defective mesh manufactured by C.R. Bard, Inc. and Davol.

Any health care providers who believe they have received counterfeit surgical meshes should not use the products and should contact the FDA’s Office of Criminal Investigation at http://www.fda.gov/OCI.

Tags: Bard, Davol, Hernia, Hernia Mesh, Kugel, Medical Device, Mesh, Patch, Surgical Mesh

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12 Comments

Anissia
I had surgery January 2012 for a hernia. I had abdominal hernia. They use Brad Mesh Flat Sheet. April 2012 I had a miscarriage. I really think that had something to do with me losing my child.
Mike
It’s pretty obvious this claim about an “unknown company” is selling counterfeit mesh comes out after many lawsuits. If I was a mesh company and I was getting sued and losing everything I would claim someone is ripping off their product too. This is unacceptable. These hospitals aren’t buying products from reputable companies? Do these hospitals have receipts from these purchases? You can sue the hospital if they are putting unknown products inside you that they can’t provide a receipt for proving they are sterile and real from a real company. I can’t work anymore. I can’t run. I was an athlete before and now I can’t even jog or stand, sit, or lay for a long period of time without pain that makes me not want to live. It’s like getting kicked in the balls all day long. I would be working a really good job making over $100,000 a year easily if it wasn’t for this pain. And this is expected to get worse throughout my life. My life is ruined. I had a great life ahead of me before this and now it’s ruined! I expect at least the salary I would be making the for the rest of my life. Let’s say 40 years times $100,000 = $4 million and that’s just for the missing work. Then there’s plenty of other things that I expect if I got a fair court case. My life is ruined! I would want at least $10 million to be content and then I still would have the pain for the rest of my life so I’d have to spend it on stuff to look at cause I can’t do anything active. Has anyone won any cases or know of anyone that has? Whats the most they were awarded? Where did they go? Details?
June
I had incisional hernia surgery on 11/26/99. This is when they used the mesh. I went to the Clevland Clinic a Main Campus, on 3/29/11 to see a Dr. For knee replacement surgery. Got my appointment left the hospital to go to lunch, ate lunch and got very sick, stomach pains and so sick! On were on our way home we got bywere by Cleveland Clinic Euclid by the Lake, and we pulled over where I started vomiting, and the pain was unreal! So my husband took me to Cleveland Clunic Euclid by the Lake ER around 3:30 pm, And they put a N G tube in my nose, I was still vomiting, and they had to reinsert the tube, I had a bowel obstruction and Was there until they transferred me to Cleveland Clinic main Campus at 1:30 am. Got to the main campus my Dr came in and said I needed surgery ASAP and so I think I went down to surgery about 5am and he had to remove all of the mesh as the mesh had moved down and wrapped around my intestine causing the bowel obstruction. Was in the hospital about 5 day! I have been trying yo find someone to take my case for awhile now, can you please help me with my case? I think I have a good case. I was so very sick from the mesh! Thank you and I will be waiting to hear from you please! Thanks so much
bernie
I had a 2 inguinal hernias one on each side of the abdomen. The left side healed nicely the right gives me so much pain. Sometimes I feel like I will not see another tomorrow. I have seen hernias specialists with no luck. I am told that it will get worse. How can it get worse when I cant walk or sit for one only hour at a time and back to bed. The mesh used was The Propolene synthetic surgical mesh by ethicon. Doesn’t the patient have the right to choose what method to use? How can they not fix something that small. The surgery was preformed in 8-2010 and it feels like it was done only yesterday.
gerald
Truth in medicine is where you will find the truth about mesh.
Kimberly
I HAD VENTRAL HERNIA REPAIR SURGERY IN MARCH OF 2005 IN DETROIT,MI. THE RECALL ACCORDING TO THE RESEARCH I’VE DONE WAS IN 2003. I DON’T UNDERSTAND WHY THIS MESH WOULD STILL BE ON THE HOSPITAL FLOOR FOR USE. I HAVE THE PROLENE(POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH BY ETHICON WHICH ACCORDING TO THE FDA AS “COUNTERFEIT”. I EXPERIENCE PAIN AT THE SITE ON A REGULAR BASIS & HAVE PROBLEMS WITH MY BOWELS.
Amy
I had this mesh implanted in me in Feb 2010 at Lexington Medical Hospital in Columbia, SC. I too had complications and received “The letter” and it is as if I have an alien inside me. It’s very disturbing to know in this day and age, such a thing can happen. I never EVER imagined I would leave the operating table with an unsterile, unravelling & unacceptable product embedded in me.
Allen
No one can be so stupid as to believe there are fake mesh when they have had years of recall to find those issues and CR Bard has a criminal history of this before the only one to gain by not finding “fake mesh” is CR Bard as if they exist, the Porto Rico Co. making them had NO quality control, got caught for it even though the corrupt FDA knows about it.
tracey
what if your love one die from a counterfiet mesh implant.what do you do is there anything at all
tracey
my husband had a counterfiet mesh put jn him 2008 and died in march 19 2010
Mary
I had polyprolene mesh put inside me in Dec.2009 and I had errosion in Feb (surgery) 25 2010, I am now going to have another surgery for errosion when they get it set up and this is Aug. of 2010, and I have so many complications from this mesh I wish I had never had the surgery for prolaspe to start with. I bleed, have trouble with sex and my bowels and I hurt all the time. I wish I could find someone to help me. I am not even healed up from the Feb. surgery yet and now surgery again .
Irene
I received a letter 7/15 from the hospital that did my laparoscopic adjustable gastric lap band surgery stating that a counterfeit polypropylene surgical mesh was used. They are saying the mesh is not sterile. What the hospital is telling me they are not going to do anything unless you are having problems. I don’t understand that why should we have to keep something in us that they are recalling and wait till something happens and possiblly be to late. Has anyone out there had this same surgery that has received the letter?

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