PerFix Plug Hernia Mesh Lawsuits
The PerFix Plug and Patch hernia mesh is manufactured by the company Bard and their subsidiary Davol, both of which are owned by Becton Dickinson. Bard is the largest hernia mesh manufacturer in the world, and the PerFix Plug has been one of Bard’s most-sold hernia meshes over the last two decades. Typically, the PerFix Plug is implanted to repair an inguinal hernia. As a result, the PerFix Plug has been one of the most utilized hernia meshes to repair groin hernias over the last 20 years. The PerFix Plug is the most common inguinal hernia mesh lawsuit filed in the Bard hernia mesh MDL 2846. The Ventralight ST is the only hernia mesh with more lawsuits against it than the PerFix Plug in MDL 2846. Of the 20,000 hernia mesh lawsuits in MDL 2846, approximately 15%, or 3,000 of the hernia mesh lawsuits are related to the PerFix Plug hernia mesh.
The Evolution of the PerFix Plug
Prior to the development of the PerFix Plug, Bard sold a similar hernia mesh called the Marlex Dart. The Marlex Dart was a pointed mesh attached to a circular mesh and resembled a witch’s hat. Like the PerFix Plug, the Marlex Dart was intended to primarily repair inguinal hernias (not that Bard/Davol didn’t encourage surgeons to implant it to repair abdominal hernias as well). The Marlex Dart received FDA 501(k) clearance on August 24, 1992. Sometime later, Bard modified the plug portion of the Marlex Dart and detached the patch portion of the mesh, creating the PerFix Plug n Patch. The Marlex Dart was then replaced by the PerFix Plug n Patch. Bard did not submit a new 501(k) for the design changes that resulted in the PerFix Plug prior to selling the PerFix Plug to be implanted in humans.
Bard Creates a PerFix Plug Market
Prior to the PerFix Plug and Marlex Dart, when mesh was utilized to repair an inguinal hernia, surgeons would typically have utilized a flat sheet of polypropylene. At the time, there was little to distinguish one hernia mesh manufacturer’s flat sheet of polypropylene hernia mesh from another manufacturer’s. These generic flat polypropylene hernia meshes did not sell for much money. Once Bard made it into a proprietary hernia mesh by creating the plug design, a lot more could be charged for the hernia mesh. The Marlex Dart and PerFix Plug were then advertised to surgeons as being designed so that the hernia defect would not need to be closed, making the surgery easier and quicker. Surgeons no longer had to be as skilled in repairing a hernia, instead, they could just plug the hernia defect. This created a very large market share for the PerFix Plug. Also, once a surgeon was hooked on the PerFix Plug technique, they would be much less likely to return to a flat mesh that would require repairing the hernia defect. The PerFix Plug became a money-making machine for Bard.
PerFix Plug Has Higher Rates of Adverse Events
In January of 2018, The HerniaSurge Group, an international group of top hernia surgeons, published the International Guidelines for Groin Hernia Management. The group advises against surgeons utilizing hernia mesh plugs, such as the PerFix Plug hernia mesh. Many of the adverse events that the HerniaSurge Group linked to hernia mesh plugs are also adverse events alleged in the PerFix Plug hernia mesh lawsuits.
PerFix Plug Migration and Erosion
Many hernia mesh lawsuits allege that patients have experienced migration and erosion after being implanted with a PerFix Plug hernia mesh. The HerniaSurge Group advised that “The incidence of erosion seems higher with plug versus flat mesh. It is suggested not to use plug repair techniques. The use of other implants to replace the standard flat mesh in the Lichtenstein technique is currently not recommended.” The HerniaSurge went on adding, “The additional cost of the device needs to be taken into account as does the small chance of mesh migration/erosion with the use of the plugs. Therefore, the Lichtenstein technique with a flat mesh is considered to be superior. See also Chapter 10 on mesh in which the problems of mesh-plug erosion and migration are described.” In regard to hernia mesh plug migration, the HerniaSurge Group found that most reports described hernia mesh plug migration within 2-3 years after implantation.
Migration or erosion of the PerFix Plug can result in extreme and debilitating pain when a nerve is grown into the moving hernia mesh. The PerFix Plug can also migrate or erode into vas deferens or spermatic cord. Severe testicular pain can result if the PerFix Plug becomes involved with the vas deferens or spermatic cord. Many PerFix Plug lawsuits claim that the patient had to have one of their testicles removed as a complications of being implanted with the PerFix Plug.
PerFix Plug Intense Inflammatory Reaction and Extensive Fibrosis
Hernia mesh devices are intended to elicit an inflammatory response in order to stimulate the body into producing collagen at the site of the hernia. However, too much inflammation is a very bad thing. The HerniaSurge Group found, “Plugs, when compared with flat meshes, have higher risks of extensive fibrosis and are more likely to stimulate an intense inflammatory reaction, thereby resulting in nonconforming biomechanical properties.”
Excessive inflammation and fibrosis can result in numerous complications and mesh failure modes. The Bard hernia mesh lawsuits regarding the PerFix Plug allege that the three-dimensional shape of the PerFix Plug, the multiple layers of the device, and the non-medical grade polypropylene utilized to make the PerFix Plug, result in an excessive inflammatory and fibrotic response. Excessive and chronic inflammation and the site of the hernia mesh can result in increased mesh contraction, mesh deformation, non-incorporation, mesh migration, nerve entrapment, chronic pain, and hernia recurrence.
PerFix Plug Shrinkage
In regard to hernia mesh shrinkage, the HerniaSurge Group found, “Mesh shrinkage varies markedly. For plugs, a volume reduction due to shrinkage of up to 90% has been reported with the formation of a so-called meshoma. It is reasonable that mesh area shrinkage of greater than 50% increases postoperative risk and should be avoided if possible by minimizing surgical trauma and/or foreign body reaction.”
Excessive Shrinkage of the PerFix Plug can obviously lead to higher rates of hernia recurrence, but it increases the risk of many other mesh complications as well. Excessive shrinkage increases the risk that the hernia mesh will migrate or erode. Furthermore, if nerves have grown into the hernia mesh, then tension can be put on those nerves as the hernia mesh shrinks, resulting in severe pain. The PerFix Plug shrinks at an excessive rate due to its three-dimensional design and propensity to incite a profound and chronic inflammatory response.
Orchiectomy (testicle removal) Due To PerFix Plug
It is believed that somewhere in the neighborhood of 4-5% of claimants in the hernia mesh lawsuits involving the PerFix Plug had to have a testicle removed due to complications of the PerFix Plug hernia mesh. The PerFix Plug is associated with abnormally high rates of testicle removals due to the PerFix Plug being prone to migrating and contracting. The Patch of the PerFix Plug is pre-cut with a “keyhole.” The patient’s spermatic cord is intended to be placed within this “keyhole.” Unfortunately, this part of this mesh also contracts over time and can then squeeze on the patient’s spermatic cord. The plaintiffs in some of the PerFix Plug hernia mesh lawsuits didn’t have their testicles removed until many years after being implanted with a PerFix Plug. The first hernia mesh trial involving the PerFix Plug is set to be a plaintiff who allegedly had to have a testicle removed as a result of complications stemming from being implanted with a PerFix Plug. The instructions for use (IFU) for the PerFix Plug do not warn patients or surgeons that implanting a PerFix Plug increases the risk that a patient will lose one of their testicles. Our hernia mesh attorneys do not believe that patients would have consented to having a PerFix Plug implanted if they were fully informed of the increased risk the PerFix Plug would put them of losing a testicle.
PerFix Plug and Chronic Debilitating Pain
The most common complaint after being implanted with Bard’s PerFix Plug hernia mesh is chronic pain, lasting for years after being implanted with the PerFix Plug. Everything discussed above, such as the chronic inflammation induced by the PerFix Plug, the plugs propensity to migrate and contract all contribute to the high rates of chronic, debilitating pain. Many patients are unable to resume a normal lifestyle due to the chronic pain they experience as a result of the PerFix Plug. Often times, only removal of the PerFix Plug will alleviate the patient’s chronic pain. For many patients though, in order to remove the PerFix Plug, their testicle must also be removed with the hernia mesh.
Lack of an FDA PerFix Plug Recall
Even with thousands of lawsuits being filed over several years alleging chronic debilitating pain and the need to remove patients’ testicles as a result of being implanted with the PerFix Plug, the FDA has not forced Bard to recall the PerFix Plug. Furthermore, Bard has not voluntarily recalled the PerFix Plug as a result of an increased rate of complications. Bard should be aware of the increased risk of complications associated with the PerFix Plug, because the HerniaSurge Group published about the increased risk in 2018. Due to the lack of a PerFix Plug hernia mesh recall, patients are still being implanted with the PerFix Plug.
PerFix Plug Hernia Mesh Trial
To date, there has not been a PerFix Plug hernia mesh trial. The next hernia mesh set to go to trial in MDL 2846 is a PerFix Plug case. The plaintiff in the first PerFix Plug hernia mesh trial is Mr. Stinson. The PerFix Plug hernia mesh trial is currently set for October 16, 2023. Plaintiff Stinson experienced chronic debilitating pain after being implanted with the PerFix Plug, eventually resulting in the removal of the PerFix Plug implant. Mr. Stinson experienced excessive inflammation and fibrosis as a result of the PerFix Plug implant. In May of 2023, Mr. Stinson underwent an additional revision surgery and had to have one of his testicles removed.
Much must happen before the PerFix Plug bellwether trial can go forward in October. First, Mr. Stinson needs to recover from having his testicle removed. Then Mr. Stinson and his treating physicians will have to be deposed again. Expert reports will also have to be updated, which will also result in additional depositions and briefings related to the experts.
The October 16th PerFix Plug hernia mesh trial is anticipated to last approximately 4 weeks. One of the experts disclosed by the plaintiffs is former head of the FDA – Dr. David Kessler. To stay up to date on the latest court orders on the PerFix Plug trial, see our Bard MDL 2846 Case Management Orders page.