Stern Law, PLLC, is currently handling cases involving hernia repair with the Parietex™ Plug and Patch System and with Parietex™ Progrip. If you had surgery to repair a hernia and suffered a postoperative injury, contact our office today to find out if you might be eligible to file a lawsuit against the manufacturer.
Types of Hernias
A hernia occurs when internal organs or tissue protrude through a weakened wall of muscle or tissue. Hernias are associated with weakened muscles because of a preexisting muscle condition, aging, or continual strain on the abdomen or groin, resulting from lifting heavy objects, chronic coughing, enduring pregnancy and child birth, being overweight, or straining because of constipation. Hernias are most common in the abdomen but can also develop in other areas of the body. They often cause pain and discomfort, in addition to creating a visible bulge on the patient’s body.
Types of hernias generally include:
- Umbilical – Hernia near the belly button
- Ventral – Hernia in the abdominal wall
- Inguinal – Hernia in the groin area
- Femoral – Hernia in the inner thigh area
- Hiatal – Hernia in the chest and diaphragm area
- Epigastric – Hernia between the chest and belly button
- Incisional – Hernia at the site of a previous surgical incision
The standard procedure to repair a hernia is surgery. During a hernia repair operation, the surgeon will push the protruding tissue or organs back in and reinforce the muscle wall to prevent the hernia from coming back.
What is the Parietex™ Plug and Patch System?
One way doctors address hernias is with surgery using mesh products, like the Parietex™ Plug and Patch System. The Parietex™ Plug and Patch System is manufactured by Medtronic, formerly known as Covidien, and is a synthetic polyester mesh designed for repair of hernias in the groin or inguinal area.
The Parietex™ Plug and Patch System contains two components: the plug and the patch.
- Plug – The plug is a flat, round piece of mesh that is folded into a cone-like shape and inserted through a small incision near the hernia site. It contains a “semiresorbable” collar made of polylactic acid “microgrips.” These microgrips resemble the little hooks on a piece of velcro and actually work in the same way by fixating to the intended object. The plug is intended to fill in the hernia defect.
- Patch – The patch is a flat sheet of monofilament polyester mesh intended to be fixed over the top of the plug to reinforce the weakened wall of tissue around the hernia.
The system comes in two sizes. The patch size remains the same, but the plug can be ordered in 6.5 centimeters and 8 centimeters.
What is Parietex™ Progrip?
Parietex™ Progrip is also manufactured by Medtronic and is a piece of monofilament polyester mesh designed for repair of inguinal (groin) or incisional hernias. It comes in an elliptical-shaped sheet that fits the groin area. The elliptical sheet is called the Anatomical Design, and it features an adjustable fixating flap to be placed around the spermatic cord in male patients.
Like the Parietex™ Plug and Patch System, the Parietex™ Progrip contains polylactic acid microgrips. Instead of the microgrips confined to the outer collar, the Parietex™ Progrip’s microgrips are spread across the entire sheet of mesh.
Both the Parietex™ Plug and Patch System and the Parietex™ Progrip are part of Medtronic’s line of Parietex™ products for hernia repair. The signature component of the Parietex™ line is its implementation of polyester in all of the products, as opposed to polypropylene. Medtronic (at the time Covidien) originally touted the superiority of its polyester mesh, claiming it was safer and more effective than polypropylene. In reality, its polyester was far from superior.
Medtronic had to make several adjustments to the polyester it used for Parietex™ mesh after releasing various products in the line. At first, the polyester was too heavy and created the same foreign body reaction that was a hallmark for its polypropylene counterparts. Patients implanted with the thick material experienced inflammation, pain, and rigid scar tissue embedment, just as they would have if they had received a polypropylene mesh implant.
In later models, Medtronic used a lighter weight polyester to try to remedy some of the reported issues with its Parietex™ products. However, the mesh was then fragile and too flexible, making it seriously vulnerable to tearing and hernia recurrence. One of the problems with all mesh implants is that they contract after implantation. When contraction occurs with the flimsy Parietex™ polyester, the mesh rips away from the sutures holding it in place. This can lead to a number of issues, including migration, perforation, pain, and hernia recurrence.
Moreover, Parietex™ mesh has unsealed edges, which can lead to mesh unraveling, fraying, and ripping. The edges can also increase the risk of perforation. Medtronic’s subsequent remedies, including an added layer of collagen, have not made the Parietex™ mesh any safer or more effective, certainly not worthy of the comparisons Medtronic makes to polypropylene.
Outside of the issues with the overall Parietex™ line, the Parietex™ Plug and Patch System and Parietex™ Progrip mesh have their own unique complications. Most of the postoperative complications patients experience from these two products in particular are due to the microgrips on the mesh. Medtronic claims these grips make the mesh “self-fixating,” eliminating the need for tacks or sutures to fasten the mesh in place, which in turn, Medtronic claims, reduces risk of pain, infection, migration, nerve entrapment, and hernia recurrence.
Medtronic, however, makes these claims with absolutely no study-backed data and no proof whatsoever that the grips eliminate or reduce those – or any other – risks. In fact, studies show the microgrips actually increase the risk of certain complications. Without sutures or tacks, when the mesh contracts, there is nothing else to hold it in the correct place. And as contraction takes place, the hundreds of hooks pull at whatever tissue they are attached to, thereby increasing patient pain.
Parietex™ Plug and Patch / Progrip Injuries
In our practice at Stern Law, we have heard clients report numerous injuries from hernia repair surgery using Medtronic’s Parietex™ Plug and Patch System and Parietex™ Progrip mesh. These injuries range in severity, with the most common of those being:
- Chronic pain – Ongoing postoperative pain is one of the most common complaints we have heard from our clients. Many report pain that radiates to their limbs and interferes with numerous aspects of their lives.
- Infection – Infection is also a common injury associated with the Parietex™ Plug and Patch System and Parietex™ Progrip. Nearly 8 percent of patients who have hernia repair surgery using mesh reported developing infections post operatively.
- Adhesions – Adhesions are large formations of scar tissue that result in tissue sticking to internal organs. Implantation of the Parietex™ Plug and Patch System or Parietex™ Progrip can trigger scar tissue formation, which often leads to adhesions.
- Mesh erosion – The Parietex™ Plug and Patch System and Parietex™ Progrip have been reported to erode into surrounding tissue and organs, causing pain, illness, and infection. Mesh erosion often requires surgical intervention to correct.
- Mesh migration – Many clients report the Parietex™ Plug and Patch System or Parietex™ Progrip changed positions after surgery, or “migrated” to another area of the body. Mesh migration usually requires a surgery to remove the existing mesh and repair the hernia again.
- Mesh shrinkage – The Parietex™ Plug and Patch System and Parietex™ Progrip material can contract or shrink into itself after surgery, which can cause the mesh to become detached from the tissue holding it in place. This can result in hernia recurrence, migration, or other complications.
- Bowel Obstruction – A bowel obstruction is a blockage of the large or small intestine. After surgery to repair a hernia using the Parietex™ Plug and Patch System or Parietex™ Progrip, inflammation and scar tissue can build up and cause the intestine to become closed off. In addition, the mesh can adhere to the intestines, causing intestinal incarceration. Bowel obstructions impede normal digestive function by preventing stool from moving all the way through the intestines. This leads to a number of serious and painful problems. Bowel obstructions must be repaired with additional surgery.
- Spermatic cord injuries – In men, particularly those undergoing repair of inguinal hernias with the Parietex™ Plug and Patch System or Parietex™ Progrip, the mesh can adhere to, perforate, or entrap the spermatic cord. This leads to pain, interference in sexual function, and in severe cases, azoospermia (a total lack of sperm in ejaculate fluid), which renders men unable to have children. Some men must also undergo removal of their testicles if the spermatic cord injury is too advanced to repair safely.
- Testicular ischemia – Men who have a Parietex™ Plug and Patch or Parietex™ Progrip mesh implanted, especially in the inguinal area, can develop a blood loss to the testicles due to the mesh cutting off regular blood flow. Some men have testicular shrinkage associated with this complication, and some men end up requiring removal of the testicles.
As many of these injuries advance, patients require surgery to remove the Parietex™ mesh. But the design of these implants can make removal almost impossible.
Parietex™ polyester mesh is porous, like a window screen, and therefore encourages rapid tissue ingrowth. Within 30 days, a rigid plate of scar tissue has usually formed around the mesh, making dissection and removal tedious and complicated. Surgeons must attempt to separate the mesh from the patient’s tissue without causing harm. Too frequently, the mesh can never be fully removed.
Removal is another complication that is exacerbated by the microgrips in the Parietex™ Plug and Patch System and the Parietex™ Progrip. The self-fixating mesh immediately fastens to the patient’s tissue, and the hooks create embedment in seconds. Instead of trying to disconnect the mesh by way of a few sutures, the removing surgeon has to try to separate all the tiny microgrips from the patient’s tissue. What was already a daunting task becomes a complete nightmare for both the surgeon and the patient.
Reports to FDA
Manufacturers, doctors, and patients can submit reports of adverse events associated with drugs and medical devices to the Food and Drug Administration (FDA). The FDA has received numerous such reports regarding the Parietex™ Plug and Patch System and Parietex™ Progrip. Some of these reports include the following descriptions:
- In July 2017, a patient reported undergoing repair of a hernia using a Parietex™ Progrip. Four months after surgery, the patient developed two additional hernias outside the mesh area. The patient presented to the hospital with severe pain, nausea, vomiting, and fever, and reported bowel issues. The patient was diagnosed with two incarcerated hernias and had to undergo additional surgeries.
- In June 2017, a facility reported that a patient’s surgeon attempted to implant the patient with a Parietex™ Progrip for inguinal hernia repair. The surgery was done robotically, and the mesh tore as the surgeon attempted to unfurl it using graspers. The surgeon removed the damaged Parietex™ Progrip and implanted another product.
- Also in June 2017, a facility reported that a patient’s surgeon attempted to use a Parietex™ Progrip for laparoscopic repair of bilateral inguinal hernia. While unfolding the mesh, the surgeon dipped the mesh in saline, and noticed the outer coating peeling away from the mesh. The surgeon discarded the mesh and used a different product.
- In May 2017, a patient reported undergoing surgery to correct a small inguinal hernia using a Parietex™ Progrip. After surgery, the patient developed pain, nausea, and vomiting. At approximately five months postop, the patient underwent an additional procedure to attempt to remove the Parietex™ Progrip implant due to chronic pain that was nonresponsive to medical treatment. The surgeon noted during this surgery that the polyester in the Progrip implant was very stiff and tense. Approximately five months later, the patient underwent a third surgery to attempt to remove more of the Parietex™ mesh. The patient was noted to be experiencing incapacitating groin pain. The surgeon noted that the mesh was clearly visualized behind the peritoneum with a severe inflammatory and fibrotic reaction involved with the mesh and surrounding tissue. The procedure was complicated due to the dense adhesions to the mesh, and the surgeon noted that the patient underwent a very significant, complicated lysis of adhesions with removal of the mesh. Again, the surgeon was unable to remove all the mesh. In so trying, the patient’s peritoneum was removed. Following this surgery, the patient developed upper right quadrant pain, nausea, and vomiting. The patient was diagnosed with cholecystitis, which resulted from prolonged attacks of inflammation from the mesh. The patient underwent removal of the gallbladder. To this day, the patient still has mesh embedded in her tissue and experiences debilitating pain.
- Also in May 2017, a patient reported severe adhesions following implantation of Parietex™ mesh. During laparoscopic surgery to remove the mesh, the patient’s surgeon encountered significant adhesions up to the anterior abdominal wall consisting of small bowel and omentum. After extensive dissection, the surgeon could no longer safely proceed in laparoscopic fashion. The surgeon converted to open surgery and discovered mesh with severely adhered bowel and omentum. The surgeon noted the small bowel made a cluster approximately the size of a softball, due to all the adhesions. The mesh could not be fully removed, and the patient continues to suffer complications from the remaining mesh.
- Also in May 2017, a patient reported experiencing bowel perforation following implantation of Parietex™ mesh. The patient required an additional procedure to repair the perforation. At the time of the report, the patient was still hospitalized and had been for more than a month. Doctors anticipated the patient would still need additional surgeries.
- In April 2017, a doctor reported that during a patient’s hernia repair surgery, the surgeon implanted a Parietex™ Progrip, and when testing the implant, the mesh ripped and frayed. The surgeon had to remove the mesh and use a different implant for the patient.
- In July 2016, Medtronic reported to the FDA that a surgeon using the Parietex™ Progrip during a patient’s hernia repair had to remove the implant and use a different product because the Parietex™ Progrip tore apart during the surgery.
Despite knowing about the potential for these Parietex™ mesh products to cause dangerous postoperative injuries, the FDA has taken little to no action. It has not recalled the Parietex™ Plug and Patch System or the Parietex™ Progrip and has not issued any statements specifically addressing the safety of these implants.
More generally, in April 2017, the FDA issued a statement addressing all hernia mesh implants. In the statement, it reported on frequent adverse events following hernia repair with mesh and stated pain, infection, hernia recurrence, adhesion, and bowel obstruction were the most common complications associated with hernia mesh. However, at the same time, the FDA downplayed the significance of mesh in these injuries by stating that the same injuries were also associated with hernia repair surgeries that did not involve use of mesh.
The FDA went on to say it had received many reports of complications related to hernia mesh, but that it had concluded recalled mesh products were the main cause of the complications. We find this bewildering, given that our clients continue to report serious injuries from their hernia mesh implants, including the Parietex™ mesh line, and given that these products have not been recalled.
Why do Doctors Use Parietex™ Mesh?
Why do doctors repair hernias with these Parietex™ mesh products if they are unsafe? There is not a simple answer to this question, but we know a large reason surgeons started to and continue to us mesh is rooted in the information disseminated to them by the mesh manufacturers.
Manufacturers paid for and conducted studies attempting to prove that mesh repair surgeries result in a lower rate of hernia recurrence than traditional hernia repair methods. These studies usually did not last long enough to capture all the injuries patients developed and did not accurately portray all of the injuries observed. Sometimes, recurrence happens 10 years after the original surgery, and those issues were not addressed in the studies.
Upon study completion, manufacturers distribute written information to doctors, invite doctors to seminars, and perform site visits to tout their products and convince doctors that mesh is the gold standard for hernia repair. They market mesh as less invasive, requiring shorter recovery time, and having a higher rate of success. They even train doctors and participate in patient surgeries to help doctors implant the mesh.
Part of the allegations Stern Law includes in mesh lawsuits are failure to warn doctors about the risks associated with mesh use and failure to provide doctors with updated information about risks and reported complications.
Where Do I Start if I Want to Pursue a Claim?
When you have been injured by a product like hernia mesh, it can be difficult to know what you should do first. At Stern Law, we keep the process simple, so you can worry less.
If you or a loved one had hernia repair surgery using the Parietex™ Plug and Patch System or Parietex™ Progrip and developed a postoperative injury, contact Stern Law, PLLC, today to talk to one of our attorneys. During your call, you will be able to schedule a free consultation with a seasoned product liability lawyer, who will explain the litigation process and the services we provide. When you hire our firm, your attorney will prepare your case by:
- Obtaining a detailed account of your surgeries and injuries;
- Ordering medical records for your original hernia operation, as well as any further treatment or surgery;
- Determining product identification, or the name of your exact mesh implant, as well as the name of the manufacturer;
- Consulting with medical experts and industry experts to obtain support for your claim;
- Determining where your case should be filed and against whom;
- Drafting and preparing a petition for filing.
We know what it takes to win in these cases, and we are ready to go to work for you.
What if I’m Unsure Whether My Surgeon Used Parietex™ Mesh?
In any product liability case, we have to establish “proof of use” or “product identification,” meaning we have to prove with certainty that you had a specific manufacturer’s product. In the case of Parietex™ mesh, we have to prove your surgeon implanted brand-name Parietex™ mesh manufactured by Medtronic/Covidien. If you are not sure whether you have this specific implant, you don’t need to worry. We will help you find that information.
Many of our hernia mesh clients come to us knowing only that they have a hernia mesh implant and not knowing for sure the name of the implant. We actually expect this because we know surgeons use their time with patients to discuss the upcoming operation and postoperative recovery. They generally do not talk to patients about implant brands or manufacturers. When you hire Stern Law to investigate your hernia mesh claim, we will obtain the necessary documentation to show what implant you have.
At the outset of our investigation, we will order medical records from the day of your hernia repair surgery. We will include in our order requests for copies of intraoperative notes and implant reports. Generally, these particular records will contain a sticker or lot number from the mesh implant packaging that will tell us exactly what implant the surgeon used. Depending on what we find out, we will continue working on your claim to include your case in our Parietex™ mesh litigation or litigation against another mesh manufacturer. There are numerous hernia mesh implants and manufacturers involved in the overall hernia mesh litigation, so it is not the end of the road if we discover you do not have a brand Parietex™ mesh implant. We will do whatever we can to help you build a successful case.
What Can I Recover in a Parietex™ Mesh Lawsuit?
At Stern Law, PLLC, we understand how these injuries affect your life, and we are dedicated to obtaining the compensation you deserve. When you file a claim for damages against Medtronic, you can recover for the ways you have been harmed. This includes claims for the following types of compensation:
- Lost wages, if you missed work or cannot currently work because of your mesh injuries;
- Lost future wages, if you will not be able to return to work;
- Past medical bills for treatment related to your mesh injuries;
- Future medical bills, if you will need additional treatment for your injuries; and
- Compensation for the physical and mental pain and suffering you have incurred and will incur as a result of your mesh injuries.
Your Stern Law team will analyze all your injuries, both economic and noneconomic, to make sure we capture the full extent of your damages and maximize the recovery you receive.
Hernia Mesh Settlement News
The hernia mesh litigation is expansive because of the volume of mesh products and number of manufacturers involved. In litigations of this size, the parties will usually try to form Multidistrict Litigations (MDLs). An MDL is essentially a consolidation of cases in one federal court. Unique MDLs can be formed for each manufacturer, based on the number of lawsuits filed against that manufacturer.
The first hernia mesh MDL formed in 2007 in the U.S. District Court for the District of Rhode Island, centralizing lawsuits filed against the manufacturer Davol Inc., regarding its Kugel™ hernia mesh patches. In 2011, Davol (through its parent corporation, C.R. Bard, Inc.) settled more than 2,000 of these cases for $184 million.
Most recently, an MDL formed to centralize hernia mesh lawsuits filed against the manufacturer Atrium Medical Corp. in the U.S. District Court of New Hampshire. There is also an active application to form an MDL for hernia mesh lawsuits filed against Ethicon, Inc. Litigation of these cases is in its early stages, so no settlement negotiations have yet taken place.
Contact Stern Law, PLLC
At Stern Law, PLLC, we are zealous advocates committed to providing you the best results. The lawyers at Stern Law are ready to help you gain stability in your life again, starting with a confidential consultation at no cost to you. At our firm, client communication is of the utmost importance. We know how frustrating it can be to wonder what is happening in your case, so we strive to keep you updated and make sure you understand how much we value you as a client. Our attorneys are caring and compassionate professionals who never forget the value of accessibility. At our firm, you are more than a case number.
If you or a loved one underwent hernia repair surgery using the Parietex™ Plug and Patch System or Parietex™ Progrip and suffered an injury related to the mesh, contact Stern Law, PLLC, at (844) 808-7529, to schedule your free consultation today.