ProLoop: Who is the FDA Protecting?

ProLoop Logo

ProLoop Lawsuit

ProLoop Ball of Polypropylene

The ProLoop hernia mesh plug is manufactured and marketed by Atrium Medical Corporation, a subsidiary of Maquet and Getinge Group (they also manufacture the extremely dangerous C-Qur hernia mesh. The ProLoop mesh has been on the market since the early 2000’s; however, the earliest available 510(K) on the FDA’s website for the ProLoop is dated August 27, 2015. Did Atrium market the ProLoop for over a decade without ever receiving FDA 510(k) clearance? The ProLoop mesh looks like a wad of tangled fishing line. And indeed, the ProLoop is made of the same material as fishing line… polypropylene. The hernia mesh attorneys at the Hollis Law Firm also believe that Atrium was using non-medical grade polypropylene in the manufacture of the ProLoop hernia mesh. The ProLoop is still being implanted into unaware victims to this day, as Atrium keeps making massive profits off of what is essentially unusable fishing line. This wasp nest of a mesh frequently results in excruciating pain and autoimmune symptoms. Many victims of the ProLoop mesh have also experienced mesh migration and subsequent operations.

ProLoop Plug: A Defective Design

ProLoop v PerFix
ProLoop (left) PerFix Plug (right)

Atrium’s ProLoop is one few polypropylene mesh plugs on the market. Another is Bard’s PerFix Plug, which the ProLoop is designed after. Coincidentally, the PerFix Plug also doesn’t have it’s original 510(k) on the FDA’s website. There is an apparent 510(k) from August 24, 1992, for a Bard Marlex Mesh Dart, but there’s no link to actual paper 510(k) summary for the device. Why is all this 510(k) talk relevant? The FDA’s 510(k) process enables device manufacturers to skip any human studies before selling the product, if the device is substantially similar to a device approved by the FDA prior to May 28, 1976 (predicate device). These are the first polypropylene plugs on the market, so what was the predicate device cited in the original 510(k)s? It’s quite the coincidence that 510(k) for both the ProLoop and the PerFix Plug are unavailable on the FDA’s website. How do we get into this hernia mesh mess? It facilitated by the FDA’s 510(k) process, the vagueness of its terms, the ease in which it can be manipulated, and an FDA that’s too cozy with the big money and players of the medical device industry.

Scientific Articles on ProLoop and Plug Meshes

Feb 2018: International Guidelines for Groin Hernia ManagementProLoop Thimble

The international group of surgeons found 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.” It was also found that “Plugs, when compared with flat meshes, have higher risk of extensive fibrosis and are more likely to stimulate an intense inflammatory reaction, thereby resulting in nonconforming biomechanical properties.” The authors of the study also note “both the anterior and posterior compartment are entered and scarred, making a subsequent repair for recurrence more difficult. Also, the amount of foreign material is higher than for a simple flat mesh. And – in the case of a combined hernia – the placement strategy is not standardized. 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 plugs. Therefore, the Lichtenstein technique with a flat mesh is considered to be superior.”

Oct 2009: A Two-Centre Blinded Randomised Control study Comparing the Lichtenstein Patch, Perfix Plug and ProLoop Plug in the Repair of Primary Inguinal HerniaProduct Identification Sticker for ProLoop Hernia Mesh

Recurrence rates with the ProLoop were more than double the rate of recurrence with the PerFix Plug.

 

ProLoop Lawsuit

ProLoop Inguinal PlugCall 1-800-701-3672 today for a free ProLoop case evaluation. Speak to one of our highly experienced hernia mesh intake specialist today. All consultations and legal work are done on a contingency fee basis. That means we cover all of the cost and only get reimbursed if we obtain compensation for you. Call the Hollis Law Firm today at 1-800-701-3672. For more information on other hernia meshes, visit our general hernia mesh lawsuit page.

 

 

Content Created By:

C. Brett Vaughn RN, BSN, JD