Federal Lawsuit Against C.R. Bard says Mesh is Not Inert

//Federal Lawsuit Against C.R. Bard says Mesh is Not Inert

Federal Lawsuit Against C.R. Bard says Mesh is Not Inert

July  30, 2012 ~ This is a brief synopsis of the  lawsuit that has been filed against C.R. Bard, a synthetic vaginal mesh manufacturer. You may see your mesh mentioned as they are all here. Summary provided by a non-lawyer so it’s best to read the actual case which is here.

Final Master Complaint in the Federal Court in the Southern District of West Virginia,  MDL #2187.

The Defendant is C.R. Bard, a mesh manufacturer based in New Jersey, as well as Sofradim Production SAS, a French company, and Tissue Science Laboratories Limited, a British company. The Plaintiffs are women who had one of more of the mesh products implanted to treat pelvic organ prolapse or stress urinary incontinence.

The following is a list of C.R. Bard transvaginal meshes that are the subject of the litigation:

a. The Align Urethral Support System;

b. The Align TO Urethral Support System;

c. The Avaulta Anterior BioSynthetic Support System;

d. The Avaulta Posterior BioSynthetic Support System;

e. The Avaulta Plus Anterior BioSynthetic Support System;

f. The Avaulta Plus Posterior BioSynthetic Support System;

g. The Avaulta Solo Anterior Synthetic Support System;

h. The Avaulta Solo Posterior Synthetic Support System;

i. The InnerLace BioUrethral Support System;

j. The Pelvicol Acellular Collagen Matrix;

k. The PelviLace BioUrethral Support System;

l. The PelviLace TO Trans-obturator BioUrethral Support System;

m. The PelviSoft Acellular Collagen BioMesh;

n. The Pelvitex Polypropylene Mesh;

o. The Uretex SUP Pubourethral Sling;

p. The Uretex TO Trans-obturator Urethral Support System;

q. The Uretex TO2 Trans-obturator Urethral Support System; and

r. The Uretex TO3 Trans-obturator Urethral Support System.

Bard designed, made, packaged, labeled, marketed and sold the Align and Align TO Urethral Support Systems as well as the Avaulta Plus Anterior and Posterior BioSynthetic Support Systems.; the Avaulta Solo Anterior and Posterior BioSynthetic Support System.

Bard had an arrangement with those two companies that they would design and manufacture, label and package the products which Bard would then sell and distribute.

The meshes made by Sofradim but sold by Bard include: Avaulta Anterior and Posterior BioSynthetic Support Systems; Pelvitex Polypropylene Mesh; the Uretex SUP Pubourethral Sling and Uretex TO, TO2, TO3 Trans-obturator Urethral Support Systems.

The meshes made by TSL but sold by Bard include: the InnerLace BioUrethral Support System; the Pelvicol Acellular Collagen Matrix; Pelvilace and PelviLace TO Trans-obturator BioUrethral Support Systems; the PelviSoft Acellular Collagen BioMesh.

The Plaintiffs claim that the polypropylene mesh (monofilament) is not inert, meaning it does not lie dormant in the body and is biologically incompatible with human tissue. In a subset of the population, an immune response is noted in the form of inflammation of the pelvic tissue and severe adverse reactions including, but not limited to, hyper-inflammatory responses, chronic pain and fibrotic reaction. Collagen products can also cause adverse tissue reactions and “are casually related to infection as the collagen is a foreign organic material from animals. Cross linked collagen is harsh upon the female pelvic tissue. It hardens in the body. When mesh is inserted in the female body according to the manufacturers’ instructions, it creates a non-anatomic condition in the pelvis leading to chronic pain and functional disabilities.”

Here is the rest of the complaint. It says in a nutshell:

  • Mesh was approved under the 510(k) FDA approval process
  • July 13, 2011 the FDA Safety Communication said mesh complications for repair of POP are “not rare”
  • FDA also said mesh shrinkage, previously unidentified, has been reported in the scientific literature
  • December 2011, a joint opinion from two organizations, the American College of Obstetricians and Gynecologists (ACOG), and the American Urogynecologic Society (AUGS) acknowledged some women  have serious complications associated with mesh
  • AUGS and ACOG recommended pelvic organ prolapse repair with mesh should be reserved for high-risk individuals “in whom the benefit of mesh placement may justify the risk.”
  • An FDA communication said the benefits of mesh may not outweigh the risks
  • An FDA White Paper states “these products are associated with serious adverse events”

Defendants should have known the above.

Count I Negligence – in failing to take reasonable care in designing, making and selling the products

Count II Design Defect (strict liability)  – the products were defective in their design

Count III Manufacturing Defect – the mesh products were made unsafe for their intended use

Count IV. Strict Liability- Failure to Warn – the Defendant didn’t warn about shrinkage, degradation, fragmentation, improper mating with the pelvic floor, mesh erosion and extrusion, the risk of chronic inflammation and infections, pelvic scarring, pain, the need for revision surgery, among other things.

Count V. Breach of Express Warranty –  Defendants assured the doctors and hospitals and general public the products were safe and effective.

Count VI. – Breach of Implied Warranty – Defendant warranted that the product was fit for its intended purpose.

Count VII. – Loss of Consortium – the woman is so injured the husband has lost her consortium, companionship, affection etc.

Count VIII. Punitive Damages – in simple terms the award is requested that punishes the Defendant for the above actions and for continuing to promote and misrepresent an unsafe product it knew or should have known would cause injury.

The Plaintiffs demand a trial by jury.

By |2012-07-30T23:08:50+00:00July 30th, 2012|Legal News|22 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. Kathleen July 31, 2012 at 1:23 am - Reply

    Wow! It is about time the truth comes out. Thanks Jane!

  2. Patty Williams July 31, 2012 at 3:24 am - Reply

    I knew it! My husband was implanted with Polypropylene mesh and suffered many of the above symptoms, still suffers with chronic pain today. Im so glad that someone spoke up with this news. Of course mesh is not inert! Its garbage! Id love to know who the experts are who helped with the science information, The facts. We need a mesh expert in our corner, hoping to find on real soon.

  3. Nonie Wideman July 31, 2012 at 3:51 am - Reply

    the truth is finally starting to emerge!!! too bad so many had to suffer before being heard……I hope the judges in these cases take strong punitive measures that shock manufacturers into ethical standards that were not being followed for fear of not only having to pay huge settlements but from some decision makers in these companies having to do some jail time, as what they did was show a wanton and criminal disregard for quality of life for patients being implanted with their products.

  4. Melinda December 5, 2012 at 1:42 am - Reply

    All I can say is “WOW”. I finally am not insane. My doctor did not understand why I was not recovering the way I should. I have had to have one revision surgery. Several silver nitrate treatments to treat the mesh coming through my vagina. Could not have sex because I have had vaginal stricture. I had to and continue to have to after seven years of suffering from pelvic pain have to still use dilators periodically. I went threw internal, yes I said it internal physical therapy for several weeks. Been on significant pain meds for years, have been unable to stand, sit, or do much activity for any length of time. All to find out that since I had the surgery in 2005, that I was a guinea pig when the products were first introduced into the market. They were introduced in January 2005, my surgery was January 5, 2005. LIterally, I was one of the first to have the surgery. Than years later to find, I have 3, yes, 3 defective products in me that can NEVER be safely removed. Who had the regard for quality of life…obviously, not the manufacturer. Now I have filed for disability and although they have deemed its a disability. The judge I had for the hearing does not believe the amount of pain I am continually in. Does she not read the news, or watch tv. The FDA, a fellow agency issued warnings regarding this yet our goverment has no regard to the effects their own agencies actions are having on individuals.

    • Ilonansanders March 14, 2013 at 6:56 pm - Reply

      I believe you and feel your pain. Ignorance was bliss!

    • Amanda July 27, 2017 at 11:43 am - Reply

      Hi Melinda was wanting to find out if you have the collagen biomesh pelvisoft bard

    • Amanda April 21, 2018 at 11:29 pm - Reply

      I am so sorry contact me and my name is Amanda 405-xxx-xxxx

  5. Ilonansanders March 14, 2013 at 6:52 pm - Reply

    I have a Bard Bladder sling. It was implanted for SUI. I have had lower right abdominal pain since 2005. It has intensified over the years, and now I suffer from the same problems I had prior to the implantation. I have had an extremely difficult time finding a doctor that will provide me with a diagnosis. Apparently, they don’t want to become involved with possible litigation. I don’t know what to do at this point, however I am certain this thing in my body is now completely destroying my health. Constant infections, problems with my complexion and involuntary muscle movement, the list goes on. I am desperate for advice as to how to proceed. I do have an attorney but had I not seen the advertisements I would have never known this was the,problem.

    • Amanda July 27, 2017 at 11:46 am - Reply

      I was wondering what kind of mesh did you have 2005 that’s when I have my surgery my pelvisoft biomesh

  6. Dave Skolyak September 18, 2013 at 12:07 pm - Reply

    I wish I could find a lawyer with some balls that is not afraid to take on Tissue Science Labs. In 2011 I had a permacol mesh implanted and have had nothing but pain, a fistula created by the mesh, constant bleeding and pussing from hole in my stomach leading from a hole in my colon caused by the mesh and much more. In about 6 months I will have to have additional surgery for stomach reconstruction and my doctor said the hole in my colon was caused by the mesh. Can anyone help. My email is ddpho@aol.com

    • jbrokenbody June 23, 2015 at 2:33 pm - Reply


  7. Laura Hunter November 18, 2013 at 12:05 pm - Reply

    you need to see a urogynecologist for a diagnosis. and you should do it for you peace of mind and your health.

  8. Jbroken July 3, 2015 at 11:25 am - Reply

    How do I find my name Jan Waters case in Mel an which court Thank u July 3,2015

    • Jane Akre July 3, 2015 at 2:15 pm - Reply

      Which kind of mesh do you have? You can go to the so district of WV, click on your manufacturer, go to numeric cases up top in small print, go to upper right hand corner and put in your last name and change the drop down box to Search by Name. It should pop up but you need to know if you are NOT filed in this MDL. I hope that helps!!

  9. Ruby Berry November 30, 2015 at 6:09 pm - Reply

    how do I file? I am a victim of the pelvicol/pelvilace product.

    • Jane Akre November 30, 2015 at 9:58 pm - Reply

      Please contact Bruce Rosenberg 954-701-5094. He is a hernia mesh expert

  10. Sharon December 7, 2015 at 10:55 am - Reply

    Again WOW………….SOOOOOOO many of us have been accused of being insane. I went to my Doctor on one occasion crying in pain .He gave me morphine it was so bad. All along thinking( Me, Doctor, Family anyone who knew Me) I was absouloutly in sane or wanting drugs. I NOW have a spinal implant for pain, It helps.

    But still we have no compensation for any of this and it may never be settled. How sad for all of us that need help.

  11. kathy stone July 20, 2016 at 11:47 am - Reply

    The doc who put the sling in blamed me for the problems I was having! He even asked if it was all in my head. After reading all this information, I have come to realize that all the mysterious symptoms I have been suffering are because of this foreign object inside of me. I was told if I had it removed, I might have to wear a diaper for the rest of my life. This was in 2011. So I only had the exposed part removed. Now I don’t know what to do….

    • Jane Akre July 20, 2016 at 12:17 pm - Reply

      Do you have a law firm? Do you have a competent doctor who recognizes mesh complications? Please write for a list…

  12. Myrtie Sullivans September 12, 2016 at 4:56 am - Reply

    How do I join this lawsuit. My medical records and surgeries are massive resulting from Pelvicol tissue (bovine) mesh with many surgeries and life altering trauma and incontinences (bowel and urine)

    • Jane Akre September 12, 2016 at 10:05 am - Reply

      please write me if you do not have representation. janeakre@meshnewsdesk.com

    • Amanda July 27, 2017 at 11:51 am - Reply

      I see that you have the biomesh also would like to talk to you we can compare our problems maybe we can help each other out my name is Amanda

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