Parietex ProGrip Lawsuit: Who is the FDA Protecting?

Parietex ProGrip Logo

Parietex ProGrip Hernia Mesh

The Parietex ProGrip is a polyester based hernia mesh with over 5,000 hooks attached to aid in fixation. The Parietex ProGrip is used primarily to repair inguinal hernias. Our hernia mesh attorneys see the Parietex ProGrip associated with debilitating pain and extremely complicated revision surgeries. The Parietex ProGrip came to the market in 2008, and is developed and manufactured by Covidien. On January 26, 2015, Covidien was acquired by Medtronic for nearly $50 billion.

Parietex ProGrip Design

Product identification sticker for Parietex ProGrip hernia mesh

The Parietex ProGrip is designed unlike any other hernia mesh on the market. The purpose of the “micro-grips” or Velcro-like hooks are to alleviate the need of tacks or sutures to secure the polyester Parietex. The company claims that the micro-grips are advantageous, because tacks are hooks are associated with an increased risk of pain and infection. However, our hernia mesh attorneys don’t see lower rates of infections with the Parietex ProGrip when compared to other inguinal hernia meshes that do utilize tacking or sutures. Additionally, the Parietex ProGrip itself causes debilitating pain. It gets worse though, the Parietex ProGrip is nearly impossible to remove after it has been implanted. Many of our clients have underwent multiple revision surgeries due to the debilitating pain caused by the Parietex ProGrip, but pieces of the mesh still remain inside of them. It doesn’t appear that the Parietex ProGrip is fulfilling its intended purpose of decreasing pain or the rate of infections.

Micro-grips of the Parietex ProGripPLA micro-grips on Covidien's Parietex ProGrip

To understand why the Parietex ProGrip is designed the way it is, it’s necessary to understand the defects of the regular Parietex. The entire Parietex line is polyester based, instead of polypropylene like many hernia meshes. There are two main differences between polyester and polyproylene, polyester is more flimsy and much weaker. Because polyester is so flimsy, surgeons had difficulty handling the Parietex during an operation. Covidien then added a collagen layer to the Parietex to give the mesh some rigidity and provide better handling. Polyester being weaker than polypropylene resulted in the Parietex tearing away from the tacks or sutures that secured it. Polyester, like polypropylene, contracts after implantation. Because polyester is weaker, tacks can tear through the Parietex as the mesh contracts and pulls on the tacks. In an attempt to fix the problem of tacks or sutures tearing the Parietex, Covidien added thousands of micro-grips so that the Parietex wouldn’t require tacks or sutures to stay in place. The micro-grips solved Covidien’s “problem” of the Parietex tearing on the securing device, but it caused patients who were implanted with it to experience debilitating pain. The micro-grips also didn’t solve the underlying problem of the Parietex, which is that it shrinks and contracts after implantation. The Parietex ProGrip is attached to the patient at thousands of different points, and then the polyester begins to shrink and contract, and the mesh pulls on all of the tissue and the nerves that it’s attached to. It is both the micro-grips themselves and the polyester shrinking of the Parietex ProGrip, which is resulting in such significant pain.

Parietex ProGrip Design Defects

Covidien's Parietex ProGrip Polyester Mesh Unraveling

Prone to Unraveling, Fraying, and Tearing

The Parietex ProGrip, like Covidien’s other polyester based hernia meshes, has a tendency to unravel, fray, and tear. The Parietex ProGrip begins unraveling and fraying before it is even implanted in many cases. The unraveled polyester fibers project from the mesh and become harder after implantation. These hardened polyester fibers can then perforate underlying organs. Several surgeons have also reported the Pareitex ProGrip tearing upon trying to implant it. The risk of the Parietex ProGrip tearing only increases after the mesh has been implanted. Covidien thought that their polyester based hernia meshes were tearing due to sutures and tacks; however, the self-gripping Parietex ProGrip has the same problem.

Is the FDA Aware of the Parietex ProGrip’s Tendency to Unravel, Fray, and Tear?

Let’s look at a few of the most notable adverse event reports that the FDA has received over the years on the Parietex ProGrip’s durability.

May 25, 2017 Update: Shortly after this page went live, the FDA’s entire online adverse event database went down. All the below links went dead. However, we had backup PDFs of the FDA’s adverse events saved to our server, which we have now uploaded and embedded below.

If the above isn’t enough evidence, the FDA received the exact same type of reports on another of Covidien’s polyester hernia meshes, which you can view here at our Parietex Composite lawsuit page. The FDA’s online adverse event database crashed while we were building the Parietex Composite page.

Reduced Patient Pain: A Marketing Gimmick

The hernia mesh industry is made up of a lot of really bad products, which compete against each other for the potential at massive profits. In order to look better than the other hernia meshes, many of the marketing teams come up with some type of gimmick, or lie. Covidien’s marketing team for the Parietex ProGrip is a prime example of a marketing team taking it too far. Considering how Covidien touts the Parietex ProGrip as being so great at reducing patient pain, one would think they did human studies prior to launching the Parietex ProGrip to support such a claim. However, Covidien did not do a single human study on the Parietex ProGrip prior to its launch. But Covidien still wanted surgeons to think that the Parietex ProGrip could decrease patient’s pain, so Coviden went ahead and put in the Parietex ProGrip’s brochure that it reduced patient’s pain. Covidien didn’t stop there though. Covidien really wanted surgeons to believe that the Parietex ProGrip would reduce patients pain, so Covidien went ahead and added citations to studies at the bottom of the page on reducing patient pain. Below is one of the pages on reducing patient pain from Covidien’s Parietex ProGrip brochure:

Brochure for Parietex ProGrip on Reducing Patient Pain

 

Note that the studies cited above are for “Parietene ProGrip” and not “Parietex ProGrip.” Parietene ProGrip is a polypropylene based hernia mesh, while Parietex ProGrip is a polyester based hernia mesh. These are two entirely different hernia meshes. Covidien is known for their polyester hernia meshes. In fact, Covidien frequently talks negatively about polypropylene based products when promoting its polyester based hernia meshes. Yet Covidien has no problem citing to a polypropylene hernia mesh study when it can make its polyester hernia meshes sound better. Below is a close up that we highlighted of the fine print on the studies cited in the Parietex ProGrip brochure on reducing patient pain.

Citation to Parietene ProGrip in the Parietex ProGrip brochure on pain reduction.

Citation to Parietene ProGrip in the Parietex ProGrip brochure

The Parietex ProGrip has been on the market for nearly a decade. It’s one thing for Covidien not to conduct human trials prior to releasing the Parietex ProGrip, but it’s even worse that they are still citing to a different hernia mesh a decade later! If it is so important to Covidien to be able to claim that the Parietex ProGrip can reduce patient pain, why doesn’t Covidien just conduct studies on the pain associated with the Parietex ProGrip? Maybe because the studies on the Parietex ProGrip show how debilitating the pain can actually be.

Scientific Articles on the Parietex ProGrip

Laparoscopic insertion of the Parietex ProGrip

March 2017: The HIPPO Trial, a Randomized Double-blind Trial Comparing Self-gripping Parietex Progrip Mesh and Sutured Parietex Mesh in Lichtenstein Hernioplasty: A Long-term Follow-up Study.

Approximately 150 patients implanted with Parietex ProGrip and another 150 implanted with regular Pareitex and sutures were compared in a double-blind study over a 2 year period. “The self-gripping Progrip mesh does not reduce CPIP (chronic postoperative inguinal pain) rates.

March 2017: Three-Year Results of a Randomized Study Comparing Self-Gripping Mesh with Sutured Mesh in Open Inguinal Hernia Repair.

Approximately 70 patients implanted with Parietex ProGrip were compared to another 70 implanted with Optilene LP mesh with sutures over a 3 year period. The researchers concluded that they “failed to demonstrate the advantages of self-gripping mesh in terms of chronic pain and foreign body feeling… Considering the higher price of self-gripping mesh, analysis of cost-effectiveness is needed to prove its advantage and to justify its usage.”

February 2017: Self-Gripping Versus Sutured Mesh Fixation Methods for Open Inguinal Hernia Repair: A Systematic Review of Clinical Trials and Observational Studies.

12 randomized, controlled trials and 5 cohort studies were reviewed. The researchers found that the “data from our analysis did not favor either of the two fixation techniques over the other in terms of recurrence or postoperative chronic groin pain. Decreased operative time in the self-gripping mesh group cannot justify a recommendation for its routine use.”

June 2016: Randomized Clinical Trial Comparing Self-Griping Mesh With a Standard Polypropylene Mesh for Open Inguinal Hernia Repair.

A double-blind randomized clinical trial compared self-gripping mesh with a standard polypropylene mesh repair over a 1 year period. The study concluded that “self-gripping mesh for hernia repair may results in less pain in the early postoperative phase but chronic postherniorraphy pain is not affected. Recurrence rates may be a potential disadvantage.”

November 2015: Randomized Multicenter Trial Comparing Glue Fixation, Self-gripping Mesh, and suture Fixation of Mesh in Lichtenstein Hernia Repair (FinnMesh Study).

Three different mesh fixation techniques were compared to find out how to perform a safe and cost-effective open inguinal hernioplasty in day-case setting with the best outcomes with regard to chronic pain. Approximately 600 patients, 200 of which were implanted with a Parietex ProGrip, were evaluated over a 1 year period. The researchers concluded that the “randomized trial failed to prove that mesh fixation without sutures causes less inguinodynia than suture fixation in Lichtenstein hernioplasty. Mesh fixation without sutures is feasible without compromising postoperative outcome.”

August 2015: Emerging Trends in Abdominal Wall Reinforcement: Bringing Bio-Functionality to Meshes.

The authors noted that Covidien had introduced new self-gripping ProGrip technology that functioned well well in rats; “however, long-term clinical studies revealed that this technology was not completely free of side-effects, and first cases of chronic pain, recurrence and other mesh-related symptoms have been reported.”

September 2014: Systematic Review and Meta-Analysis of Published Randomized Controlled Trials Comparing the Role of Self-Gripping Mesh Against Suture Mesh Fixation in Patients Undergoing Open Inguinal Hernia Repair.

1,115 patients over four randomized, controlled trials of patients undergoing self-gripping mesh versus suture mesh fixation were compared. The researchers found that self-gripping mesh “failed to demonstrate the reduced incidence of postoperative groin pain following open inguinal hernia repair.”

June 2014: The Comparison of Self-Gripping Mesh and Sutured Mesh in Open Inguinal Hernia Repair: The Results of Meta-Analysis.

The outcomes of 1353 patients enrolled into 5 randomized controlled trials and 2 prospective comparative studies were compared. The researchers concluded that self-gripping mesh compared with conventional suture fixed lichtenstein technique did not reduce chronic or acute pain.

March 2014: Prospective Randomized Trial of Long-Term Results of Inguinal Hernia Repair Using Autoadhesive Mesh Compared to Classic Lichtenstein Technique With Sutures and Polypropylene Mesh.

Two groups of 45 patients were compared over 1 year. One group was implanted with an autoadhesive mesh and the other group was implanted with sutured polypropylene mesh. The study concludes that “the use of autoadhesive and partial reabsorbible meshes in inguinal hernia repair has no effect on recovery of daily activities, postoperative pain and long term complications compared with hernioplasty with polypropylene mesh fixed with monofilament suture.”

March 2013: Randomized Clinical Trial of Self-Gripping Mesh Versus Sutured Mesh for Lichtenstein Hernia Repair.

163 patients with self-gripping mesh were compared with 171 with sutured mesh over a 1 year period. The researchers concluded that “the avoidance of suture fixation using a self-gripping mesh was not accompanied by a reduction in chronic symptoms after inguinal hernia repair.”

Covidien's Parietex ProGrip inguinal hernia mesh

Parietex ProGrip Lawsuit

Product Identification sticker for Covidien's Paritex ProGrip

Contact one of our hernia mesh lawyers today for a free Parietex ProGrip case evaluation. 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 Parietex ProGrip hernia mesh lawsuit evaluation. Follow our Parietex ProGrip Lawsuit FaceBook page to stay up-to-date on the Parietex ProGrip. For more information on Covidien polyester based hernia meshes, please visit our Parietex lawsuit page and our Parietex Composite lawsuit page.

Content Created By

C. Brett Vaughn RN, BSN, JD