C.R. Bard is a maker of popular hernia mesh products, but many of them have been defective. As a result of their defects, patients have sustained injuries ranging from mild and temporary to severe and permanent. If you have been injured, it is possible that you can file a claim for compensation. Lawsuits are pending, and more lawsuits are filed regularly. We are here to provide you initial information on Bard mesh products and an update on Bard hernia lawsuits occurring in the United States.
- 1. Why are hernia repair patients filing lawsuits against C.R. Bard?
- 1.1 What are specific reasons for lawsuits against the Composix Kugel?
- 1.2 What are specific reasons for lawsuits against the ST hernia implant?
- 1.3 What are specific reasons for lawsuits against the 3DMax implant?
- 1.4 What are specific reasons for lawsuits against the PerFix plug?
- 2. What is the status of current lawsuits against C.R. Bard?
- 3. How do I know if I qualify to file a lawsuit against C.R. Bard for the defective hernia mesh product used in my hernia repair surgery?
C.R. Bard is well known for its hernia mesh products, but many have come under fire for alleged defects. These defects have caused serious injuries, and so injured patients are fighting back for compensation. Specific mesh products involved in lawsuits include the ST hernia mesh, the Composix Kugel, the 3DMax, and the PerFix plug.
The Kugel hernia patch is one of the oldest patches available and used in the United States. But in 2012, the product was finally and completely discontinued. Before it was pulled completely from the market, Kugel experienced two rounds of FDA recalls:
- Between 2005 and 2006, the memory recoil ring was found to break easily, which led to
- In 2007, another recall was administered due to the same problem with the PET recoil ring.
The ring was part of the Kugel design intentionally so that the mesh could be folded and then “pop” open and into place once implanted. The ring was also meant to help hold the shape of the implant. Injuries -- as noted above -- resulted when these rings would break.
Another problem with the Composix Kugel is the same problem so many other hernia implants have been recalled or are now the subject of lawsuits: use of cheap polypropylene plastic. The Composix Kugel was made with a polypropylene base and a layer of expanded polytetrafluoroethylene (ePTFE). The problem was twofold:
- Polypropylene is known to cause complications, like chronic inflammation, when it comes into contact with tissue and organs. 1
- The combination of polypropylene and ePTFE was a bad match. The two plastics are known to degrade, but when they do, they degrade at different rates. 2 The latter effect deforms the mesh and that's when the ring often breaks. Thus, the patient can have problems with the broken ring as well as secondary complications resulting from the mesh migrating and possibly perforating other organs and tissue.
In 2007, Bard acquired licensing rights to Genzyme's Sepramesh and Sepra Technology (ST) coating. Bard used the ST coating to expand its own line of hernia mesh products. One such expansion was the Ventralex ST. This coating, however, produces strong reactions and complications in patients. Some specific injuries reported include:
- Bowel obstructions
To note, in 2002, the Vetralex ST was initially approved by the FDA via its 510(k) clearance system. 3 Thus, it was able to forego the stringent pre-market clinical studies required before approval. In order to qualify for the 510(k) clearance approval program, Bard asserted that Vetralex was substantially similar to its Kugel mesh. The Kugel mesh, of course, was eventually and completely taken off the market due to its many defects.
The 3DMax is a heavy-weight polypropylene mesh. Its primary use is in the treatment of inguinal hernias. Its light-weight counterpart (the 3DMax Light) was released in 2008. Most complaints pertain to the heavy-weight 3DMax. The alleged defects include but are not limited to:
- The mesh is made of dangerous materials. The polypropylene, once implanted, begins to degrade, crack, and break, caused all sorts of problems. 4 Primary complications include mesh migration, organ perforation, nerve damage. In the case of this 3DMax, there have been claims of the mesh eroding through tissue so much so that it attaches to the spermatic cord. If treated early, then the problem can be fixed. If treated too late, the testicle may have to be removed.
- The mesh is prone to folding over and migrating. Over time and as the mesh shrinks, it folds on top of itself. From November 2007 on through the present day, the FDA has been receiving adverse reports of the mesh folding over and causing injuries. 5
- The sealed edge is prone to tearing. The sealed edge of this meant is designed for two purposes: (1) to help hold the shape of the mesh; and (2) to prevent the mesh from perforating surrounding tissue or organs. The problem: it has a tendency to fray and tear. Surgeons have been reporting on the same since September 2011. 6 These tears occur both externally (e.g., found torn in the packaging) and internally (e.g., torn while inserting or after implantation). 7
Despite these adverse reports and complaints, the 3DMax has not been pulled from the market and the FDA has not issued a recall.
The PerFix plug is used primarily to correct inguinal hernias. It is used largely among male patients, but these patients have been reporting complications, like severe, chronic groin and leg pain. The mesh is also made of polypropylene. Its shape is like a shuttlecock and has an optional onlay patch.
The problem with this mesh is -- in addition to its material makeup of polypropylene -- it has a tendency to erode and migrate. The PerFix plug has a cone tip, which when in migration can be the cause of additional pressure and pain. It can even be the cause of some men having to lose a testicle, just like in the case of the 3DMax mesh. 8
Bard and its subsidiary Davol are facing lawsuits throughout the U.S. for personal injuries and wrongful deaths due to the above-listed and other hernia mesh products.
To date, Bard won one trial against it and lost another, paying out $1.5 million to the plaintiff. 9, 10 Due to that case, bard promptly settled another 2,000+ cases for a total of $184 million with the average payout to each person around between $60,000 and $70,000. But one condition of the latter settlement was the condition of not admitting liability. 11
3. How do I know if I qualify to file a lawsuit against C.R. Bard for the defective hernia mesh product used in my hernia repair surgery?
To establish first and foremost whether you may or may not be eligible to file a claim against a manufacturer like Bard for alleged injuries due to its product, you should consider the following:
- Did you have hernia repair surgery?
- Was a Bard hernia mesh product used?
- Do you know if that product was defective (see above for possible defects)?
- Did the defect cause an injury?
- Was/Is that injury monetarily quantifiable?
If the above apply, then you may be eligible to file a lawsuit for compensation. The best way to determine what your options are is to contact experienced personal injury attorneys who have specific mass tort experience in medical malpractice and/or product liability. But timing is everything -- if the statute of limitations runs out, you can't file a lawsuit.
Our personal injury and product liability attorneys are currently taking hernia mesh cases now. We have offices locally throughout California but accept these types of cases throughout the United States. Call our office today at (855) 396-0370 or complete our online form. We will review your case and your options with you.
- Baylon, Karen et al. Past, Present and Future of Surgical Meshes: a Review. Membranes 2017, 7(3), 47; doi: 10.3390/membranes7030047. See also, Sternschuss, G, Ostergard, DR, Patel, H. Post-implantation alterations of polypropylene in the human. J Urol. 2012 Jul;188(1):27-32. doi: 10.1016/j.juro.2012.02.2559. Epub 2012 May 12.
- Cozad, MJ, Grant, DA, Bachman, SL, Grant, DN, Ramshaw, BJ, Grant SA. Materials characterization of explanted polypropylene, polyethylene terephthalate, and expanded polytetrafluoroethylene composites: spectral and thermal analysis. J Biomed Mater Res B Appl Biomater. 2010 Aug;94(2):455-62. doi: 10.1002/jbm.b.31675.
- FDA. 510(k) clearance approval of Vetralix ST.
- Supra note 1.
- FDA. Adverse Reports on the 3DMax implant.
- FDA. Adverse Reports on the PerFix Plug.
- Moylan, Tom. 1st Bellwether Trial in Kugel Patch MDL Ends in Defense Verdict. LexisNexis Legal Newsroom. April 15, 2010.
- AboutLawsuits.com. Kugel Hernia Patch Lawsuit Results in $1.5M Verdict. August 24, 2010.
- BioSpace. Davol Lawsuits to Largely End with C.R. Bard $184 Million Settlement. July 6, 2011.