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2018 European Study Recommends Against Use of Bard Perfix Plug Hernia Mesh

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

A few years ago, a group of European experts on hernia repair collaborated on a study to determine how to provide better patient outcomes in hernia repair surgery.  The group, known as the HerniaSurge Group, comprising international surgeons and one anesthesiologist pain expert was formed. The group consisted of members from all continents with specific experience in hernia-related research. Care was taken to include surgeons who perform different types of repair and had preferably performed research on groin hernia surgery.

Their collaboration led to a group recommendation against recommending the Bard Perfix Plug hernia mesh medical device because of its propensity to erode after implantation causing infection, severe abdominal pain, and revision surgery to remove the eroded medical device.

In the last three decades, hernia mesh devices have become popular alternatives to the suture-only alternatives that surgeons have used for centuries. By 2000, mesh accounted for 90 percent of groin hernia repairs, according to the FDA.

Like many hernia mesh medical devices, the Bard Perfix Plug hernia mesh is composed of polypropylene, a cheap plastic material that has been favored in the manufacturing of hernia mesh because it has been deemed inert.  However, a 2012 study in the Journal of Urology concluded polypropylene is no longer inert after it is implanted in a person’s body. They did not find a reason why that happens. But they did find physical properties of polypropylene had changed in samples they had removed from patients. They also cited other studies that report a wide variety of chemical changes in polypropylene mesh taken from patients.

The core problem with this type of medical device is the design. 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. Further exacerbating the problem is the mesh’s tendency to erode making it far more difficult to remove without damaging or removing other organs.

Our firm has already filed a number of hernia mesh lawsuits throughout the country. We have extensive hernia, pelvic organ prolapse, and stress urinary incontinence mesh litigation and settlement experience against a number of medical device manufacturers. If you or someone you know has suffered due to Bard Perfix Plug Inguinal Hernia Mesh, the experienced medical device attorneys at Rheingold Giuffra Ruffo Plotkin & Hellman LLP are here to protect your rights.

Contact us today online or by telephone at 888-335-9457 to speak with a knowledgeable New York and New Jersey product liability lawyer.

David B. Rheingold, Partner

David B. Rheingold, Partner

David specializes in an active trial practice primarily involving drug products, medical device liability and product liability cases. On both a state and national level, he has obtained substantial client settlements through arbitration, mediation and direct negotiations with some of the largest national and international drug and medical device makers. David has been involved in multiple high-profile legal cases including the $2.5 billion DePuy ASR and DePuy Pinnacle metal-on-metal hip implant settlement plan and the $1.4 billion Stryker Rejuvenate metal-on-metal hip implant settlement plan.

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