Parietex Composite Lawsuit: Who is the FDA Protecting?

Parietex Composite Hernia Mesh Logo

The Parietex Composite is a polyester based hernia mesh with a delicate collagen film created by Covidien, a subsidiary of Medtronic. In 2011, Covidien came out with the Parietex Optimized Composite hernia mesh. The Parietex Optimized Composite was intended to fix problem with the regular Parietex Composite. In the Parietex Optimized Composite 510(k) submitted to the FDA, Covidien explains that the “Parietex Optimized Composite Mesh has been modified compared to the predicate devices as the knitting textile has been modified to obtain a higher mechanical resistance of the mesh and the collagen film formulation has been changed to get a film more resistant to handling.” However, the Parietex Optimized Composite has the same problems and results in the same complications as the regular Parietex Composite. With both versions of the Parietex Composite hernia mesh, the collagen film is ineffective at protecting the bowel, the polyester tears easily, and the mesh doesn’t properly incorporate into the abdominal wall.

Product identification sticker for Parietex Composite hernia mesh

Parietex Composite Design Defects

Protective Collagen film tearing on Covidien's Parietex Composite Hernia Mesh

Collagen Film: An Ineffective Protective Barrier

Approximately a decade ago, the manufacturers of polypropylene based hernia meshes started to apply a coating to their meshes. Without conducting any human trials, the manufacturers launched the meshes claiming the coatings would protect the patient’s underlying organs. The hernia mesh manufacturers were attempting to expand their markets. Less skilled surgeons could repair a hernia with mesh laparoscopically, but laparoscopic insertion required placing the mesh closer to the bowel. In an attempt to keep up with its competitors, Covidien marketed the collagen film of the Parietex Composite as being an effective tissue barrier. However, the collagen film of the Parietex Composite does absolutely nothing to protect underlying organs from the polyester. The Collagen film begins breaking down and falling off the polyester within seconds of coming into contact with moisture. The instructions for use (IFU) also instructs surgeons to hydrate the Parietex Composite prior to implanting it. Not only does the collagen film break down too quickly, it’s incredibly delicate prior to being hydrated. The protective collagen film easily tears while simply handling the mesh. The cheap, frail collagen film is tasked with the all important duty of protecting a patient’s vital organs. The amount and severity of injuries that our hernia mesh attorneys are seeing associated with the Parietex Composite is absolutely staggering! But wait a minute, this mesh has been on the market for approximately a decade, how could something so horrible possibly go unnoticed? Maybe it didn’t go unnoticed, maybe the FDA just turned a blind eye again. Covidien was definitely very aware of the problem, which is exactly why they came out with the Parietex Optomized Composite Mesh (PCOX) in 2011. The Parietex Optimized Composite Mesh 510K even admits that the new “collagen film formulation has been changed to get a film more resistant to handling.” Unfortunately, the PCOX is still suffering from the same defects and causing the same injuries as its predecessor.

Is the FDA Aware that the Parietex Composite’s Collagen Film Is Ineffective?

Below are excerpts from adverse event reports the FDA received regarding the Parietex Composite and PCOX’s collagen film being ineffective.

  • Sept 2016: Parietex PCOX Adverse Event Report MDR# 5964626 “On the 8th day postoperative by 5pm, there was frank intestinal fluid coming through the wound. An urgent exploratory laparotomy revealed intestinal fluid under both flaps. There was a small hole at (adherent to) the summit of the mesh…” “Then the patient developed irreversible SIRS. The patient died. There were complications due to perforation of the small bowel.”
  • Nov 2015: Parietex Composite Adverse Event Report MDR# 5201030 “Four days following the procedure, the patient presented with increasingly intense pain… during the explantation of the mesh, it was noted that there were laminar adhesions between the mesh and the intestine.” “The patient was brought to the intensive care unit (icu) following the procedure. Since the procedure, the patient has subsequently experienced intestinal atony, worsening leg movement and depression for which he is currently being treated.”
  • Sept 2015: Parietex PCOX Adverse Event Report MDR# 5091293 After implantation patient “was admitted on an emergency basis to the hospital where it was noted he was suffering from left lower quadrant abdominal pain and small-bowel obstruction. It was determined at that time that immediate surgery was required to address the medical condition. It was noted that the mesh had failed, which necessitated a partial removal of the mesh.”
  • Jun 2015: Parietex PCOX Adverse Event Report MDR# 4819498 “A visual examination of the returned device showed a tear of the collagen-based film and textile at one edge.”
  • Dec 2014: Parietex Composite FDA Adverse Event Report MDR# 4222462 “Patient experienced significant abdominal wall adhesions.”
  • Jun 2014: Parietex PCOX Adverse Event Report MDR# 3966212 “The collagen film of the mesh was damaged out of the packet.”
  • Jun 2014: Parietex Composite FDA Adverse Event Report MDR# 3896228 “Patch was implanted for the treatment of umbilical hernia. Patient has been experiencing pain and swelling to the abdomen, nausea and vomiting and UTI’s.”
  • Mar 2014: Parietex PCOX FDA Adverse Event Report MDR# 3851204 “The mesh was hydrated and inserted by the doctor as he always does with the pco mesh. When he wanted to fixate the sutures on the mesh, we saw that the right side of the composite film was hanging lose from the mesh and it would be a big risk for adhesions if he tacked and left the mesh in the patient.”
  • Jul 2013: Parietex PCOX FDA Adverse Event Report MDR# 3236896 “Had to reoperate on the same patient as the patient had adhesion where the bowel was stuck together and on re-operating it was noted that there were adhesions that were also attached firmly to the mesh.”
  • May 2013: Parietex Composite FDA Adverse Event Report MDR# 3143157 “The collagen film broke down after a few seconds. Absorbatack fixation and tacks dropped off from pco mesh. (tacks were not applied on the edge). Further, the attached fixation sutures were also detached from the mesh while the surgeon was knotting for fixation.”
  • Aug 2012: Parietex Composite FDA Adverse Event Report MDR# 2708505 “Pt started experiencing pain after mesh was put in place. Mesh had adhered to her small bowel causing injury to it. Part of the mesh was taken out and she would like for the whole mesh take out.”
  • May 2012: Parietex Composite FDA Adverse Event Report MDR# 2617881 Patient underwent a subsequent operation, during which “the surgeon found out that the intestine was sticking on the whole surface of the mesh.”
  • Mar 2012: Parietex Composite FDA Adverse Event Report MDR# 2510457 “Adhesions had caused small bowel to become strangulated… The patient spent four days in the hospital recovering.”
  • Jan 2012: Parietex Composite FDA Adverse Event Report MDR# 2430082 “Adhesions had caused small bowel to become strangulated.”
  • Oct 2011: Parietex Composite FDA Adverse Event Report MDR# 2301667 “During the ventral hernia repair the product failed and needed the enteral fistula. The patient is now stable with diet and nutritional support.”
  • Mar 2011: Parietex Composite FDA Adverse Event Report MDR# 2015720 “Mesh was opened and hydrated with sterile saline. Mesh was inserted into the pt and stitched to fascia with continuous and interrupted sutures. Anti-adhesion barrier was facing the bowel. After almost all the mesh was sutured in place, the surgeon noticed that some of the anti-adhesion barrier had peeled off the mesh. He tugged at a piece of hydrogel that was lifted off the mesh and an approximately a 3cm x 3cm piece of hydrogel peeled off the mesh. Surgeon cut the sutures and removed the mesh.”
  • Feb 2011: Parietex Composite FDA Adverse Event Report MDR# 1988246 “Pt was discharged after 2 days but returned to surgeon approx 2 weeks post-operatively. Complaining of recurrence. The surgeon reported it as a bowel obstruction and repaired it again via an open approach.”
  • Jan 2011: Parietex Composite FDA Adverse Event Report MDR# 1971470 “The hydrogel coating was separated from the mesh and lay on the bowel. It was glued with the bowel and it was dissected off extensively.”
  • Dec 2010: Parietex Composite FDA Adverse Event Report MDR# 1933012 “After three days post-operation, it was noticed that the bowel was perforated and a laparotomy was necessary. The hydrogel coating had separated from the mesh and lay on the bowel.”
  • Nov 2010: Parietex Composite FDA Adverse Event Report MDR# 1900243 Patient “experienced abdominal pain and incisional drainage and a ct suggested small bowel strangulation/ischemic bowel.” The surgeon “noted 2 small bowel loops had become lodged in spontaneously formed holes in the mesh. Resection and re-anastomosis was performed and a new mesh was placed.”
  • Sept 2010: Parietex Composite FDA Adverse Event Report MDR# 1890026 The mesh had to be explanted 9 months after implantation due to infection. “The pathology report for surgical mesh specimen synthetic material with foreign body reaction dense fibrosis with chronic inflammation and a small abscess.”
  • Sept 2009: Parietex Composite FDA Adverse Event Report MDR# 1471267 “Approx 1 month post-operation, a problem occurred with the pt developing a fistula. Pt was brought back to the OR, and it was found that the mesh from the original case (ventral hernia) had become stuck to the bowel. The mesh from the original ventral hernia was removed, and the repair was done with a competitor’s mesh.”
  • Aug 2009: Parietex Composite FDA Adverse Event Report MDR# 1454867 “The product was completely coated with adhesions and infected. Allegedly, the patient complained of heavy pain, and it was necessary to explant the product.”
  • Apr 2009: Parietex Composite FDA Adverse Event Report MDR# 1364435 21 days after implantation “the surgeon stated that the mesh was destructed from suture. Mesh stuck to the bowel.”
  • Jun 2008: Parietex Composite FDA Adverse Event Report MDR# 1064734 Five days after implanted “patient’s bowel had completely grown through the mesh and fistualized in two separate locations. Extensive lysis of adhesions and bowel resection was performed. Patient was left with a stoma and transferred to the I.C.U. About 3 days later, the patient died.”

Polyester fibers fraying and unraveling from Covidien's Parietex Composite Hernia MeshProne to Unraveling, Fraying, and Tearing

Like all of Covidien’s other polyester based hernia meshes, the Parietex Composite is prone to unraveling, fraying, and tearing. Once the polyester fibers unravel, they then detach from the mesh and travel to other parts of the body. The polyester fiber will then incite an inflammatory response where it embeds.  Many patients have re-herniated after they cough and their Parietex Composite rips in half. To make matters even worse, it can be dangerous to remove a failed Parietex Composite, because it frequently adheres to the bowel. The Parietex Composite also contracts over time, causing tension to increase where the tacks or sutures secure it. Eventually, the Parietex Composite will tear where it is tacked or sutured. The Parietex Composite is a ticking time bomb. The longer it’s implanted, the more likely it is to fail. Covidien is again very well aware of this defect, it’s why Covidien came out with the Parietex ProGrip, which has “micro-hooks” so that tacks or sutures aren’t required (it’s just another defective Covidien polyester hernia mesh though). It’s especially hard to fathom that the FDA isn’t aware that the Parietex Composite is prone to tearing, because they received tons of the same adverse event reports on Covidien’s Parietex ProGrip.

Is the FDA Aware that the Parietex Composite is Prone to Unraveling, Fraying, and Tearing?

Below are excerpts from adverse event reports the FDA received regarding the Parietex Composite and PCOX unraveling, fraying, or tearing.

Need more evidence that the Parietex is prone to tearing? Check out our Parietex ProGrip lawsuit page, it has the exact same type of FDA adverse event reports regarding it.

Scientific Articles on Parietex Composite Hernia Mesh

Feb 2017: Comparative Study of Polypropylene Versus Parietex Composite, Vicryl, and Ultrapro Meshes, Regarding the Formation of Intraperitoneal Adhesions.

Animals were implanted with a Parietex Composite in one side of the abdominal cavity, and a bare polypropylene mesh in the other side. The researchers found that “there was no difference between Parietex Composite and the polypropylene in the formation of adhesions.”  The adhesions most commonly affected the “omentum, spermatic cord, liver, and small intestine.” Additionally, the researchers noted handling difficulties with the Parietex Composite, because “the collagen biofilm underwent contraction when in contact with fluids.”

Apr 2015: Mesh Ingrowth with Concomitant Bacterial Infection Resulting in Inability to Explant: A Failure of Mesh Salvage.

4 patients were implanted with the Parietex Composite mesh. All 4 patients developed a staph infection leading to chronic purulent wounds and long-term complications. In all 4 patients the Parietex Composite hernia mesh was unable to be fully explanted. The researchers concluded the “structural qualities of certain types of mesh create ingrowth into tissues even in the setting of infection, resulting in inability to explant with subsequent long-term chronic wound complications.”

Sept 2012: Biomechanical and Histological Evaluation of Abdominal Wall Compliance with Intraperitoneal Onlay Mesh Implants in Rabbits: A Comparison of Six Different State-of-the-Art Meshes

The results found that the Gore Dualmesh and Parietex Composite Meshses.

Jan 2010: Shrinkage of Intraperitoneal Onlay Mesh in Sheep: Coated Polyester Mesh Versus Covered Polyproplyene Mesh.

The Parietex Composite polyester mesh was compared with the Dynamesh, a polypropylene mesh coated with polyvinylidene flouride (PVDF). The Parietex Composite was found to have “induced a more intense foreign body reaction and was exposed to significantly more shrinkage than the covered polypropylene mesh.”

Jan 2003: Prevention of Adhesion to Prosthetic Mesh.

The ability of the Parietex Composite and the Sepramesh to prevent adhesion formation in the first 30 days was evaluated. It was found that “Infection was more prevalent with Parietex composite mesh, with concurrent increased mesh surface covered by adhesions after 30 days.” The researchers also noted that the Parietex Composite “showed a stronger inflammatory response.”

Covidien: Parietex Composite Lawsuit

Call 1-800-701-3672 to speak to one of our hernia mesh intake specialist.  All case evaluations and consultations are FREE, CONFIDENTIAL, and carry NO RISK or OBLIGATION. The specific facts of your lawsuit will determine if your lawsuit is compensable and to what amount. Follow our Parietex Composite Lawsuit FaceBook page to stay up-to-date on Parietex. For more information on Covidien’s polyester based hernia meshes, check out our Parietex lawsuit page and our Parietex ProGrip Lawsuit page.

Content Created By:

C. Brett Vaughn RN, BSN, JD