Composix hernia mesh is one of the many different mesh products made by C.R. Bard. This company has been making allegedly defective hernia mesh mesh products for many years. However, judged by the number of lawsuits filed against the company, C.R. Bard seems to have a checkered record when it comes to the safety of its products. Currently, Composix is one of the hernia mesh products that have sparked thousands of lawsuits against Bard Medical that are currently pending as part of two massive consolidated hernia mesh litigation in Federal Court and State Court in Rhode Island.
Composix, Composix E/X and L/P Hernia Mesh
Bard Medical (formerly known as C.R. Bard) has at least a dozen different types of hernia meshes on the market. It is one of the world’s biggest sellers of hernia mesh along with Ethicon, Covidien (now Medtronic) and Atrium. Bard medical joined Becton Dickinson when Becton Purchased Bard / Davol for 24 million in April 2017. Davol Inc. located in Rhode Island is a subsidiary of Bard. Composix itself is a broad product line that is intended to be used in ventral hernia surgeries. Included in the Composix family of hernia meshes are:
- Composix- “Composix, is constructed of double layer of small pore, heavy weight, unsuitable polypropylene, that is heat bonded to single layer of ePTFE.” Also known as “Composite Prosthesis.” IN RE: DA VOL/ CR. BARD HERNIA MESH MESH- MULTI—CASE MANAGEMENT Coordination N0. 20 1 7-02
- Composix E/X– “Composix E/X Mesh is constructed of single layer of small pore, heavy weight, unsuitable polypropylene, that is stitched to layer 0f ePTFE using polytetrafluoroethylene (PTFE) monofilament thread. The peripheral edge of the mesh is heat sealed to the ePTFE layer.” Id.
- Composix L/P
(Please note that Bard Composix Kugel Patch (The CK Patch) is beyond the scope of this article. The Kugel hernia patch has been subject to numerous recalls by the FDA. In 2011 CR. Bard settled 2600 Kugel hernia mesh lawsuits for 184 million. These hernia mesh lawsuits were pending in an MDL in RI Federal Court. Victims received on average $70,000 in the global settlement. The CK Patch is not to be confused with Composix hernia mesh, Composix L/P mesh and the Composix E/X hernia mesh. Read: Bard Davol hernia mesh timeline)
The FDA Approves Composix Hernia Mesh Without Testing
All Bard Composix hernia mesh entered the medical device market market as a result of the controversial 510k premarket notification pocess. This type of approval means that the FDA does not need to specifically approve this particular device. Instead, the manufacturer is warranting that the medical device is substantially similar to an already approved device that is legally marketed. Therefore, the FDA never saw any test results for the Composix mesh nor did it have a firsthand look at any data. Instead, C.R. Bard merely informed the FDA that it was going to start selling the product. There was no human clinical trial for this mesh prior to its release.
- Approved by the FDA through the contoversial and infamous 510(k) notification process back in 1997.
- Original Name: BARD COMPOSITE PROSTHESIS
- Read the 510(k) Premarket Notification
- Predicate devices: 1) Bard Marlex Mesh (Davol Inc.) and 2) GORE-TEX Dual Mesh W.L GORE and Associates, Inc.
- Read the 510k Summary for Safety
- Was approved in 2000 through the use of a similar 510k Premarket notification process.
- Device Name: COMPOSIX E/X MESH
- Predicate device names: Composix Mesh (Davol Inc.), SpermaTex Mesh (Davol Inc.)
- Read the 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE COMPOSIX E/X MESH
- Read the Premarket Notification for the Bard® Cornposix® LIComposix L/PP Mesh
- Read the 510(k) Summary of Safety and Effectiveness:
- Predicate devices: (1) Bard Composix® EIX Mesh, K002684 (Davol Inc.) (2) Bard Large Pore SoftTMesh Pre-Shaped, K052155 (Davol Inc,), FDA cleared
on 10/20/2005; (3) Davol Delivery System (currently marketed as PrecisionPass Laparoscopic Delivery Device),
- Approved by FDA on October 23rd, 2006
- Device Name: BARD COMPOSITE L/P MESH
Composix Hernia Meshes Are Two-Sided
One of the features of this line of C.R. Bard Composix products are two-sided. One side is made out of polypropylene. This is a synthetic substance that is a type of plastic that is not always well-received in a patient’s body. The other side is made from something called ePTFE. The two are supposed to work together. The polypropylene is placed against the hernia and is supposed to build scar tissue at the site of the hernia. The ePTFE faces outwards and is supposed to minimize the scar tissue.
However, each side of the Composix hernia mesh may disintegrate and erode. When this happens it can irritate the surrounding areas. In many cases, the nerves and muscles have grown into and around the mesh, magnifying the problem that the patient faces. While there has been much attention focused on polypropylene as being dangerous, the ePTFE may be even more dangerous because it can erode more quickly and significantly.
In fact, one aspect of the lawsuits that claim that these hernia meshes have a defective design specifically argue that the two-sided design specifically contributes to disintegration. The fact that each side is made out of a different material leads the mesh to be unstable insofar as one side shrinks faster than the other. For patients, this can become a ticking time bomb in their body that can go off even years after the surgery
C.R. Bard Has Made Large Profits off of Composix Hernia Mesh
For C.R. Bard, selling Composix hernia mesh has been profitable. In its 2004 Form 10-K, the company disclosed that its hernia patches gave it a position of market leadership. By 2016, hernia meshes were a prominent part of the surgical implant division of C.R. Bard that had sales of over $600 million. However, there were problems lurking beneath the surface.
Wrongful Death Cases
One 2018 lawsuit was filed as a wrongful death claim by the widow of a man who allegedly died from complications of his hernia mesh surgery. The surgery was performed in 2007, and the patient was doomed to a lifetime of pain and discomfort. The complaint alleges that the deceased suffered from fistula and foreign body reaction from the time that he received the hernia mesh until the time of his death in 2016. Now, the widow is seeking compensation for the suffering that her husband was forced to endure as well as wrongful death damages for her.
Hernia Mesh Can Have a High Failure Rate
In Composix and Composix E/X, the mesh failure rate can be as high as ten percent. There are different degrees of mesh failures. In more serious cases, C.R. Bard Composix hernia meshes have been blamed for a number of injuries. Some cases have even resulted in death. At the very minimum, some plaintiffs have been forced to undergo a number of hernia surgeries when their Composix mesh failed.
The Side Effects of Composix Hernia Mesh
The major problem with Composix products is that they tend to disintegrate. The mesh fails and pieces of the mesh move out of place and through the patient’s body. When this happens, the mesh pieces can affect surrounding tissues and organs. This will cause a patient intense and continuous pain. The difficulty is that surgery may not be successful at removing all of the pieces of mesh. At a minimum, a patient will need multiple surgeries. Even then, doctors may not be completely successful at taking out the disintegrated mesh.
Here are some side effects that patients have suffered from defective hernia mesh:
- Mesh failures
- Disintegration (mesh shrinkage)
- migration of the mesh
- Bowel obstruction
- Organ perforation
To date, Bard / Davol (Bard Medical) has contested the lawsuits filed in regard to its Composix mesh. None of the major manufacturers have conceded liability to date in their hernia mesh cases The mesh manufacturers refusal to accept responsibility is perhaps considering the massive amount of damages they would need to pay in settlements. However, we may soon know the legal status of hernia mesh as some of these cases are set to go to trial in 2020.
Composix L/P and Composix E/X Remain on the Market Despite Complaints
While C.R. Bard has pulled other hernia mesh products from the market and has issued recalls, it still continues to sell Composix and Composix E/X products. However, customer complaints and incident reports reveal that these products are not completely safe. Thus, the company continues to sell a product that is reportedly linked with numerous consumer injuries. However, neither the company nor the FDA have done anything to date about the product.
The Status of the C.R. Bard MDL
Currently, there is multi-district litigation against C.R. Bard in the Southern District of Ohio. The bellwether cases have been selected. Currently, the parties are battling over expert witnesses. The initial cases were slated to be tried in court in 2020. However, due to COVID-19, the parties jointly requested to push the trials off until 2021. The court only partially granted the request and moved the first C.R. Bard bellwether case to September 29, 2020. As of this writing, there are 3,610 cases that are a part of the multi-district litigation. The first jury trial will give the parties an idea of how the case stands.
There are also thousands of Bard / Davol hernia mesh lawsuits pending in Rhode Island state Court.