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XenMatrix Recall: Surgical Grafts May Not Meet FDA Safe Toxicity Levels

  • Written by: Staff Writers
  • 11 Comments

Davol, a subsidiary of C.R. Bard, has announced that it is issuing a recall for XenMatrix, a hernia and abdominal surgical graft, due to a failure to meet the FDA’s standards for endotoxins. 

The XenMatrix recall was announced on Tuesday in a filing with the U.S. Security and Exchange Commission. There has been no official announcement from the FDA or a press release.

C.R. Bard officials have said that the recall came after the company realized that it could not get the XenMatrix surgical graft to meet the FDA’s acceptable levels of endotoxins, according to a report by the Wall Street Journal. However, the company indicates that there have been no consumer complaints regarding the XenMatrix.

Davol acquired the XenMatrix in September 2009 from Brennan Medical. It is a collagen matrix patch used to treat hernias in the abdominal wall when the connective tissue has ruptured.

Endotoxins are usually gram-negative bacteria which can cause toxicity in the human body. Examples include bacterial meningitis, and meningococcal disease; which causes sepsis.

The XenMatrix is not the only surgical product that C.R. Bard and Davol have had problems with in recent years. The companies currently face about 3,000 lawsuits over their Kugel hernia patch products, which allegedly contain design defectives that caused plaintiffs to suffer severe internal injuries. A Kugel hernia mesh recall has been issued for several different models of the patch.

C.R. Bard also faces a growing number of lawsuits over their Bard Avaulta surgical mesh, which is used to treat pelvic organ prolapse in women. Complaints allege that the vaginal mesh system was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement. In October, the federal Bard Avaulta litigation was consolidated for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia as part of a multidistrict litigation (MDL).

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11 comments

  1. Suzy Reply

    I had a mesh bladder sling inserted on Oct. 6, 2008. Immediately I was in severe pain in my abdominal and buttock area. The pain was so severe that I couldn’t bend my right leg, making walking excruciating and sitting down impossible. I had to crawl on my left knee onto the bed and then fall over to a laying position which caused such excruciating pain I almost fainted and would sweat profusely. Immediately after surgery I also had numbness on the entire right side of my private are both inside and out, in my rectal area and down my thigh about 5 inches. The only way I could have a bowel movement was with a prescription laxative and mineral oil and I could not feel when I was urinating causing a lot of messes. It was almost 8 weeks before I could bend my leg enough to sit, but it was still extremely painful. I bled each time I had intercourse to due vaginal granulation. In Oct. 2009 I had part of the mesh removed because it had eroded through my vaginal wall. It’s been over 2 years since the initial surgery and I still feel a lot of pressure in my rectal area and buttock when I need to have a bowel movement. I also have a lot of issues with urination. I think I’m done but when I lean another direction I start all over urinating. If I move 5 different ways I urinate 5 times during one sitting. This surgery has negatively affected my way of life and happiness. I would not have had the surgery had I known of the complications surrounding it.

  2. tom Reply

    had xenmatrix used tro close chest after cabage in june of 2009. went into toxic shock after two weeks and have been having problems with infectious agents since the cabage and subsequent repair of the opern chest resulting from the failure of bard product/ docs cliam my problems arise from other unspecified factors.

  3. Josh Reply

    My wife had this mesh used on her abdominal wall reconstruction for hernia repair. She then developed a Seroma that swelled and reopened the incision creating an open tunneling wound. She then had surgery to remove the wound. About a month later the seroma again caused her incision reopen. At this time we switched doctors and he cut out the wound and put her on a wound vac of which she was just taken off of 2 weeks ago and we are now doing Dacon’s dressing twice daily till she is healed. I looked up about the gram-negative bacteria that this mesh was release more than normal of and found out that this is probably the reason she developed the seroma that wouldnt go away and caused all our other problems with her having an open wound.

  4. Dawn Reply

    abdominal mesh and have come into multiple complications.

  5. Judith Reply

    I had surgery for a hernia on 10/30/2009. i had a second surgery on Thanksgiving day that same year. The surgeon used Xen-Matrix-Biological Mesh. The surgeon told me at the time that it was cadaver skin. A year later i went to his office and asked again and he wrote it down for me. Biological Mesh-Xen Matrix. Since that time I have been diagnosed with MRSA, incontinence of bowls, blood in stool, low grade fever, constant abdominal pain, using fentanyl patches to try to control the constant pain. Now the doctors are thinking i am making this all up. I have become allergic to Zvyox one of the antibiotics for MRSA. I am getting frustrated trying to some relief from the pain I have ask if it was possible that my body is rejecting the mesh and have gotten an answer.

  6. Stephanie Reply

    not sure if this is the same type of patches, but they used the biologic matrix patch when they did pelvic prolapse surgery. Two months later I had osteomyelitis in the spine & lost use of my leg lost 40 pds. Stayed in the hospital for 2 months, was on intervenious antibiotics now on oral antibiotics & not sure if I am going to live through it yet. They want to blame it on where I did drugs but I didn’t have it before I had the surgery. I have to wear a back brace & I am skin & bones.

  7. Carole Reply

    I had the xenmatrix mesh for an abdominal surgery. Hernia, shortly after had to have it removed do to serious infections, had 7 abdominal surgeries to follow, I’ve never been the same, it was put in ,8, 2011

  8. Amy Reply

    I had abdominal wall torn out by seatbelt injury : zen matrix mesh placed and I experienced multiple infections, mesh disintegration from infection and mesh was taken out and more zen matrix mesh intalled. Again, multiple infections, 3 bouts of sepsis, fistula pain and erosion. My intestines are now matted together, the zen matrix mesh has grown into my left hip flange causing my body to respond with excess bin growth over the mesh. I had deep painful area for several months and awoke to an ulcerated hole in my skin exposing rotting, infected mesh. The Zen matrix mesh was found to have the hair follicles left intact and there’s pig hair growing from the hair follicles. The mesh is so embedded in my organs and intestines that I couldn’t physically survive its removal. I cannot find any law firm willing to take my case- they are only representing vaginal patches , although they are the same product. I suffer constant pain and my surgical team expects thT my intestines will disintegrate or I will experience multiple organ failure as a direct result of the Zen Matrix mesh erosion: That I am still alive exceeds all the best medical expectations . I don’t understand that “no problems ” have been reported. The mesh that eroded out of my body happened only a couple of years after it was “installed” , the doctors said it usually takes years before they see mesh eroding out of the body as mine has , yet pain management doctors seem to disbelieve the pain I experience as a direct result of the bad mesh- confirmed by biopsy- and the extremely delicate state of my intestines and internal organs – they continually disregard my surgeons directions and my self reporting and prescribe harsh and inappropriate medications for my condition: I’m struggling to keep a positive attitude or hope for my future as the constant pain- which can be relieved via appropriate med’s , but isn’t being at the moment. I welcome any suggestions or others personal experience with similar difficulties.

  9. Thomas W. Reply

    3 surgery and now need one more xenmatrix biological mesh is what have now. I have a hernia the shape of a small foot ball right below my ribs.

  10. Candace Reply

    Had the abdominal hernia from a recent gallbladder surgery and doctor put in the zen matrix mesh Had 60 ml drained and have felt like a big hard object is in my abdomen and have a bulge there that doesn’t go away. I am miserable every day is bad especially when I eat like I will blow up. Changed doctors and he believes it feels like area is getting weak. So I am going to be like this always? Stinks.

  11. Karen Reply

    I had hernia repair in 01242015, for the next 6 weeks I was in pain everysay, until my stomach literally burst open that was 03162015 and just recntly had a bowel obstruction

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