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

Jul 30th, 2012 | By | Category: Legal News

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.

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10 Comments to “Federal Lawsuit Against C.R. Bard says Mesh is Not Inert”

  1. Kathleen says:

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

  2. Patty Williams says:

    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 says:

    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 says:

    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.

  5. Ilonansanders says:

    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.

  6. [...] -Questions to Ask Before Mesh Removal -Transvaginal Mesh Lawsuits -Federal Lawsuit Against C.R. Bard says Mesh is Not Inert -Complications of synthetic mid-urethral slings -Transvaginal Mesh Complications and Problems [...]

  7. Dave Skolyak says:

    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

  8. Laura Hunter says:

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

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.