PerFix Plug Lawsuit: Who is the FDA Protecting?

PerFix Plug LogoBard PerFix Plug Lawsuit

 

Point of the PerFix PlugThe PerFix Plug hernia mesh lawsuit is against C.R. Bard and its subsidiary Davol Inc. The PerFix Plug is typically used to repair inguinal (groin) hernias. Men are ten times more likely than women to experience an inguinal hernia. Many men are reporting severe, chronic groin and leg pain after being implanted with the PerFix Plug. The pain is so debilitating that numerous men report being unable to work or even walk. Our hernia mesh lawyers have received reports of debilitating pain from teenagers, athletes, and veterans. The pain is real, it’s severe.

 

PerFix Plug: A Defective Design

PerFix Plug mesh

The PerFix is woven polypropylene hernia mesh plug. Polypropylene is a type of cheap plastic that degrades and erodes through tissue once implanted. The woven design of the PerFix Plug creates small pores (holes) throughout the mesh. Nerves grow into these pores and attach to the mesh soon after implant. As the mesh erodes and moves through the inguinal canal, it pulls and stretches the nerves attached to it. The nerves stretching is what’s causing debilitating pain. Additionally, pain caused from nerves stretching is essentially unable to be treatable. Opioids are not effective at treating nerve pain.

Our hernia mesh lawyers have also observed a large number of PerFix Plugs coming unwoven. In many cases, the patients body rejects small pieces of the PerFix Plug that’s came unwoven. The rejection process is slow and results in a chronic non-healing wound, at times leading to an infection.

 

Like the 3DMax (which is also made by Bard), the PerFix Plug should be removed before it erodes into the spermatic cord in men. Once the PerFix Plug has eroded into the spermatic cord, it could become impossible to remove without also removing a testicle. Consult hernia repair specialist if you are experiencing chronic pain after being implanted with the PerFix Plug.

Heavy-weight v Light-weight PerFix Plug
PerFix Plug vs PerFix Light Plug

Scientific Articles on the PerFix Plug

Feb 2018: Unfixed Mesh Plug Migration From Inguinal Ring to Urinary BladderPerFix Plug Deployed

11 years after implantation with a mesh plug, a 65-year-old man presented with frequent urination and blood in his urine. “Imaging suggested mesh plug migration on the urinary bladder.” A partial cystectomy with extraction of the foreign body was performed.

Jan 2018:Peritoneal Cecal Cancer Metastasis to a Mesh-Plug Prosthesis: A Case Report

A case report of cecal cancer metastasizing to the scar tissue of an inguinal mesh plug. The authors noted that “the relationship between peritoneal chronic inflammation and implantation of cancer cells is stated as a hypothesis.” “These processes may suggest that the floating cancer cells implanted and proliferated in the peritoneum of the mesh inserted site under the influence of the cytokine.”

Jan 2015: A Case of Mesh Plug Migration into the Bladder 5 Years After Hernia Repair

5 years after repair with a PerFix Plug, an 80-year-old women presented with right inguinal pain and fever. The PerFix Plug had penetrated into the bladder and resulted in a mesh infection. The authors noted that “Recently, there are several reports concerning complications after hernia repair with a mesh plug. According to the reports, mesh migration was observed in the perperitoneal space, small intestine and colon, and scrotum.” “The question is how mesh plug migration occurs…There are no obvious reasons why the mesh plug migrated into the bladder in our case.” The surgeons also found that the “mesh plug and the onlay mesh slightly shrunk compared to their original size.”

Nov 2011: Impact of Endoscopic and Histological Evaluations of Two Different Types of Mesh Plug for a Groin Hernia Model.Petals of the PerFix Plug

18 PerFix Plugs were implanted and then explanted and evaluated 3 months later. 10 of the 18 PerFix Plugs had inverted. Additionally, “the triangular shape of Perfix plugs was broken and the vertical/horizontal ratio was enlarged during the observation period.”

May 2005: Prolene Hernia System Compared with Mesh Plug Technique: A Prospective Study of Short- to Mid-Term Outcomes in Primary Groin Hernia Repair

Patients implanted with a plug experienced chronic groin pain at three times the rate non-plug repairs. The authors note that the high rates of chronic groin pain associated with plugs could be due to the “high profile configuration, and the cone tip of the plug acts as a pivot, bearing the greatest pressure. According to the laws of physics, pressure equals force divided by area, so the smaller the contact area the greater the pressure. Tangential shearing force around the plug may be another factor. Para-internal ring interstitial hernias and plug migrations have been reported, largely due to a relatively unstable underlay structure and to inadequate fixation. We hypothesize that any tilt or drift of the plug with uneven pressure and distorted anatomy plays some pathogenic role in the chronic groin pain and possible interstitial hernia along the plug margin after prosthetic hernia repairs.”

Dec 2004: Comparative Laparoscopic Evaluation of the Prolene Polypropylene Hernia System vs. the PerFix Plug repair in a porcine groin hernia repair model

“Where the PerFix devices are used under these conditions, they must be adequately secured to a healthy fascial edge, with onlay coverage patches to eliminate any weak points that might cause early recurrence.”

Aug 2002: Inguinal Hernia Repair: Where to Next?

“To date, there has been no published review of the evidence regarding the newer mesh repair techniques… Highlighted is the lack of evidence regarding chronic significant posthernioplasty pain – this has an incidence of 6 – 12%. This complications is 3 – 5 times more common than recurrence after open repair, is clinically relevant, is poorly understood and has been poorly studied. Arguably it is a more important end point than recurrence.”

PerFix Plug Lawsuit

Contact our skilled hernia mesh lawyers today for a free PerFix Plug case evaluation. An attorney and a medical professional will look over your case and let you know what they believe the best course of action is for you. The Hollis Law Firm does not handle class actions. Each claim is an individual lawsuit. The specific facts of your lawsuit will determine if your lawsuit is compensable and to what amount. The Hollis Law Firm represents clients and files lawsuits nationwide. All case evaluations and consultations are FREE, CONFIDENTIAL, and carry NO RISK or OBLIGATION. Call 1-800-701-3672 for a Bard PerFix Plug hernia mesh lawsuit evaluation.

PerFix Plug hernia mesh by Bard Davol. Key hold polypropylene inguinal mesh.

Content Created By:

C. Brett Vaughn RN, BSN, JD