Covidien Parietex™ Composite Mesh
Stern Law, PLLC, is currently handling cases involving hernia repair with Medtronic (Covidien) Parietex™ Composite mesh. If you had surgery to repair a hernia using mesh and suffered an injury following your operation, contact our office today to find out if you might be eligible to file a lawsuit against the manufacturer.
Types of Hernias
Parietex™ Composite mesh is a product surgeons use to repair hernias. A hernia occurs when internal organs, like the intestines, protrude through a weakened wall of muscle or tissue. Hernias are most common in the abdomen but can develop in a variety of areas and often cause pain and discomfort, in addition to creating a visible bulge on the patient’s body.
Generally, hernias fall into one of the following categories:
- 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 typical treatment for a hernia involves surgery to push the organs back into place and reinforce the weakened muscle or tissue wall to prevent hernia recurrence. One of the products surgeons use to accomplish this goal during a hernia operation is Parietex™ Composite mesh.
What is Parietex™ Composite Mesh?
Parietex™ Composite mesh is manufactured by Medtronic (formerly known as Covidien) and is an implant designed for repair of inguinal and ventral hernias. Introduced in 1999, Parietex™ Composite mesh is formed from two layers of synthetic polyester woven into porous sheets. The layer of mesh that faces away from the muscle and rests inside the patient’s body is coated with an absorbable layer of collagen, polyethylene glycol, and glycerol.
Parietex™ Composite mesh comes in several shapes and sizes, depending on the hernia size and the area wherein the hernia is located. This particular mesh can be used during laparoscopic or open hernia repair surgery and is intended to be a permanent implant.
Medtronic sells a line of products to fix hernias, mostly implants made of polyester fibers woven into pieces of mesh. One of its more popular lines is marketed under the name Parietex™ and includes mesh of varying shapes, sizes, and materials. Some of Medtronic’s most well-known Parietex™ products include:
- Paritex™ Composite Mesh – Synthetic polyester mesh designed for repair of inguinal and ventral hernias. Introduced in 1999, Parietex™ Composite mesh comes in several shapes and sizes, depending on the hernia size and the area where the hernia is located. It can be used during laparoscopic or open hernia repair surgery and is intended to be a permanent implant.
- Parietex™ Plug and Patch System – Synthetic polyester mesh designed for repair of hernias in the groin area. The plug in the Parietex™ Plug and Patch System 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. The plug fills in the hernia defect, and then the patch, or flat sheet of mesh material, is fixed over the top of the plug.
While these products are intended to keep the herniated tissue in place and reinforce the weakened muscle wall, they unfortunately carry a number of serious side effects. Most of these side effects are rooted in the design and material composition of the Parietex™ mesh.
Parietex™ Composite Mesh Defects and Injuries
Medtronic touts its Parietex™ Composite mesh as superior to polypropylene alternatives because of the polyester it uses to make the mesh. The 2017 Parietex™ Composite mesh product booklet states that the implant is made of a macroporous polyester that is “more hydrophilic than polypropylene, providing improved biocompatibility and superior cellular proliferation in vitro.” The booklet goes on to state that the Parietex™ Composite mesh is “the first mesh to offer a resorbable collagen barrier on one side to limit visceral attachments, and a three-dimensional polyester knit structure on the other to promote differentiated tissue ingrowth.” It also states the Parietex™ Composite mesh is “optimized to minimize shrinkage.”
In other words, Medtronic markets its Parietex™ Composite mesh as a better hernia repair option than polypropylene because of the polyester and collagen properties designed to prevent foreign body reactions associated with polypropylene. Medtronic knew that patients implanted with polypropylene mesh experienced intense inflammation and thick scar tissue formation (also known as “adhesions”), along with pain and infection. The corporation, therefore, pushed its Parietex™ Composite mesh as free of those problems.
In a study published in early 2017 (Comparative Study of Polypropylene Versus Parietex Composite, Vicryl and Ultrapro Meshes, Regarding the Formation of Intraperitoneal Adhesions), researchers put Medtronic’s superiority claims to the test, comparing the effects of polypropylene mesh implants against Parietex™ Composite mesh. After studying the postoperative effects of implanting the two types of mesh in rats, they concluded Parietex™ Composite mesh had the same propensity for adhesions as polypropylene, and that Parietex™ Composite mesh was actually more difficult to use in some cases.
First, the researchers noted “difficulties with Parietex™ Composite … in the present study, since the collagen biofilm underwent contraction when in contact with fluids.” In addition, they found no significant difference in the percentage of the mesh covered by adhesions when comparing polypropylene to Parietex™ Composite mesh. Both types of mesh were affected by adhesion to the omentum (a membranous double layer of fatty tissue that covers and supports the intestines and organs in the lower abdominal area) and to the spermatic cord. The liver was affected in 25 percent of the animals, and the small intestine was also affected in 5 to 10 percent of the animals.
This information is alarming, not only because it demonstrates Medtronic’s statements about its polyester mesh are misleading, but also because it suggests that the Parietex™ Composite mesh’s collagen biofilm, which is designed to supposedly prevent adhesions, in reality, makes the mesh more difficult to use. Clearly, because these implants are indicated for implantation inside the human body, they will come in contact with fluids. The fact this study observed contraction in the Parietex™ Composite mesh upon fluid contact is deeply concerning.
Unlike what Medtronic says, Parietex™ Composite polyester mesh causes a rigid plate of scar tissue to form around the mesh. Not only does this cause patients pain, it also becomes a huge problem if the mesh implant needs to be removed. Surgeons must attempt to separate the mesh from the patient’s tissue without causing harm to healthy tissue. It is a complicated and tedious process when scar tissue is embedded in the mesh and sticking to healthy tissue and organs. Sometimes, complete removal is impossible. When the Parietex™ Composite mesh cannot be fully removed, patients are then left to suffer from the pieces of mesh that permanently remain in their bodies.
Additional Parietex™ Mesh Injuries
Many hernia patients who have Parietex™ mesh implanted suffer postoperative complications. Our extensive experience in hernia mesh litigation has shown us how serious these complications can be. Our clients report a range of injuries, from minor infections only requiring a round of antibiotics to major medical problems requiring multiple surgeries.
The most common injuries from Parietex™ hernia mesh implants we have seen in our practice include:
- Chronic pain – Many patients who come to us with mesh complaints report being in constant pain. The pain is often localized to the site of the mesh implant, sometimes with pain radiating out to the limbs.
- Infection – Up to 8 percent of patients who have hernia repair surgery using mesh reported developing infections post operatively. The infection can be simple, requiring a round of antibiotics, but it can sometimes be severe, necessitating further surgical procedures to clean out the infected tissue.
- Adhesions – Adhesions are intense buildups of scar tissue that result in tissue sticking to internal organs. The mesh implant tends to cause a large amount of scar tissue formation, which often leads to painful adhesions. Though adhesions frequently carry no noticeable symptoms, they can cause pain or make any subsequent surgeries more complicated by making it difficult to isolate organs and healthy tissue during a surgery.
- Bowel Obstruction – A bowel obstruction is a blockage of the large or small intestine. After surgery to repair a hernia using mesh, 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.
- Mesh tearing – Patients have reported their mesh implants tearing after surgery, potentially leading to recurrence of the hernia or other bodily injury. Mesh tearing usually requires a repeat hernia repair surgery.
- Mesh erosion and perforation – Hernia mesh has been reported to erode into or perforate surrounding tissue and organs, causing pain, illness, and infection. In severe cases, mesh erosion or perforation can lead to nerve damage. In most cases, mesh erosion and perforation require additional surgery.
- Mesh folding – Hernia mesh has a tendency to fold into itself after implantation. This folding results in mesh failure and recurrence of the hernia, as well as increased risk for scar tissue formation and damage to surrounding tissue and organs. Mesh folding typically requires a repeat hernia repair surgery.
- Mesh migration – In some cases, the mesh implant will move positions inside the body or “migrate” to another area of the body where it is not containing the hernia and has the potential to damage surrounding tissue and organs. Mesh migration usually requires a surgery to remove the existing mesh and repair the hernia again.
- Mesh shrinkage – The material that comprises the mesh has been known to contract or shrink into itself in the months following implantation. When this occurs, the mesh can become detached from the tissue holding it in place, leaving the patient vulnerable to migration and resulting problems. Mesh migration will usually require a repeat hernia repair surgery.
- Intestinal fistula – An intestinal fistula is an abnormal hole or opening in the gastrointestinal tract that allows contents of the stomach or intestines to leak out. Hernia mesh can cause these fistulas through intense inflammation and pressure or by eroding through or perforating the intestines. These fistulas cause pain, diarrhea, nausea, dehydration, and malnutrition.
- Spermatic cord injuries – In men, particularly those undergoing repair of inguinal hernias with mesh, hernia 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 hernia 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. The January 2017 Parietex™ Indications for Use states that its “absorbable hydrophilic film minimizes tissue attachment to the mesh,” but immediate tissue embedment is nevertheless a major problem. 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 to healthy tissue. Sometimes, complete removal cannot be accomplished, and patients are left to suffer with the pieces of mesh that permanently remain in their bodies.
Reports to FDA
The Food and Drug Administration (FDA) has long been aware of the potential for dangerous postoperative complications from hernia repairs using Parietex™ Composite mesh. One of the ways the FDA becomes aware of medical device complications is through submission of adverse event reports. Manufacturers, healthcare professionals, and individual patients can submit reports of adverse events to the FDA, and through the years, numerous reports have been submitted regarding Parietex™ Composite mesh.
- In June 2017, a patient reported having a panniculectomy because fat necrosis had grown into the patient’s Parietex™ Composite mesh implant. The patient had to be hospitalized and had two subsequent surgeries. This event was categorized as a serious injury.
- Also in June 2017, a patient reported pain, abdominal discomfort, and difficult bowel movements following implantation of Parietex™ mesh. The pain intensified during the next year, and the patient had to go to the emergency room. The patient was told the hernia had recurred. The patient still has abdominal pain and discomfort.
- Also in June 2017, a patient reported requiring an additional surgery after a hernia repair using Parietex™ mesh. The patient had experienced immense ongoing and prolonged pain and suffering, and the surgeon performing the subsequent operation discovered the Parietex™ mesh had split open.
- Also in June 2017, a patient reported abdominal pain and distension following implantation of Parietex™ mesh. The patient required surgery approximately 2.5 years after implantation to remove extensive adhesions. The patient then underwent a third surgery approximately a year thereafter. The patient continues to experience pain and has severe scarring and disfigurement.
- Also in June 2017, a patient reported having Parietex™ Composite mesh implanted and requiring surgery to remove the mesh because of pain and discomfort. During the removal surgery, the surgeon discovered the mesh had adhered to the patient’s small intestine. The patient had to have several inches of intestine removed to extract the mesh. Since this surgery, the patient has experienced ongoing pain, difficulty digesting food, bloating, gas, and acid reflux. In addition, the patient reported that the hernia recurred.
- Also in June 2017, a patient reported her Parietex™ mesh implant migrated following surgery, which caused her to have pain and numbness in her groin and leg. The mesh could not be found during an attempted removal, and the patient reports it is still lost inside the patient’s body. The patient reports being unable to walk or sit for long periods of time and being barely able to get out of bed some days due to pain.
- 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 undergoing hernia repair using Parietex™ Composite mesh. Following surgery, the patient experienced pain and vomiting. Upon additional surgery, the surgeon discovered the mesh had torn, and the patient’s bowel was protruding through the 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.
These reports capture a fraction of the adverse event reports for Parietex™ Composite mesh from just the months of May and June 2017. Surprisingly, despite being aware of the volume of complications reported on this type of hernia mesh, the FDA has been relatively silent on the matter. The FDA has not recalled Parietex™ Composite mesh, and it has not issued any warnings or statements as to Parietex™ Composite mesh specifically.
In April 2017, the FDA issued a statement addressing hernia mesh in general, in which it reported on frequent adverse events following hernia repair with mesh. The FDA stated pain, infection, hernia recurrence, adhesion, and bowel obstruction were the most common complications associated with hernia mesh. In doing so, however, the FDA minimized these injuries by noting that the same complications occurred with all mesh surgeries, with or without use of mesh.
In the same statement, the FDA went on to say it had received many reports of complications related to hernia mesh, but that the Administration had concluded recalled mesh products were the main cause of several of these complications. Tellingly, men and women around the country continue to report postoperative hernia mesh injuries, while almost no hernia mesh implants have been recalled for safety reasons.
Our clients describe the same injuries as reported to the FDA, many of which result from implantation of Parietex™ Composite mesh. Where the FDA has failed to take strong action, we will. The best way for you to protect your rights is to pursue an individual claim against Medtronic.
Why do Doctors Use Parietex™ Composite Mesh?
While mesh has become a tremendously popular way to repair hernias, it is not the only technique surgeons can use. And we argue other techniques are safer. Surgeons still have options to repair hernias without using any mesh or any synthetic material at all. For instance, they can repair hernias using sutures, and the patient’s own fascia (fibrous tissue), tendons and ligaments. Using this technique, surgeons essentially sew the muscle back together or use the patient’s own tissue, tendons, and ligaments to create a stronger wall above the herniated tissue.
Using the patient’s own natural tissue prevents many of the foreign body reactions patients struggle with and avoids other mesh complications altogether. Additionally, if the hernia reoccurs, or another complication occurs, the surgeon can resolve those issues without having to worry about whether he will be able to remove mesh that might have become completely encapsulated with scar tissue. If scar tissue formation is advanced, mesh might never be able to be fully removed, which limits a surgeon’s repair options and inhibits a patient’s potential for total recovery.
So why do doctors repair hernias with mesh, including Parietex™ Composite mesh, if it causes so many problems, and if they have safer alternatives? There is not a simple answer to this question, but we know a primary reason is rooted in the information disseminated to surgeons by the mesh manufacturers.
Manufacturers, including Medtronic, 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. In example, Medtronic generated study data supposedly proving its Parietex™ Composite mesh was better than other mesh because of its polyester and collagen properties. In reality, these studies ignored the complications of Parietex™ Composite that directly mirror polypropylene mesh injuries.
Upon study completion, Medtronic and other mesh manufacturers distribute written information to doctors, invite doctors to seminars, and perform site visits to plug their products and convince doctors their mesh is the new gold standard for hernia repair. They market their mesh as different, more convenient, safer, more effective. They even train doctors and participate in patient surgeries to help doctors implant the mesh.
When Stern Law’s lawyers file a lawsuit against Medtronic for Parietex™ Composite mesh injuries, we address the close relationship between Medtronic and surgeons. We allege in these suits that Medtronic failed to properly train and warn doctors regarding the mesh procedure and all the risks involved.
How Do I Know Whether My Surgeon Used Parietex™ Composite Mesh?
In order to file a lawsuit against Medtronic, you have to establish you, in fact, had Parietex™ Composite mesh implanted. We have found that many times, our clients do not know what mesh implant they have. In some cases, they are not even sure they have mesh. We understand surgeons usually talk to their patients about the upcoming procedure and expected results, rather than spending consult time talking about brand names and manufacturers.
When you hire Stern Law, we will investigate your implant and find out what brand of mesh you have. We will immediately request your medical records, including copies of the intraoperative notes and implant reports from the day of your hernia repair surgery. Those records will usually contain a product sticker or lot number that identifies the specific brand and manufacturer of your mesh implant. We call this sticker or lot number “product identification.”
If we find out your hernia mesh implant is not Parietex™ Composite, we will work to include your case in litigation against a different mesh manufacturer.
Stern Law Offering Free Parietex™ Mesh Claim Review
At Stern Law, we know our clients have already endured costly treatment and revision surgeries because of their hernia mesh injuries. We understand that they could be struggling under the weight of costly medical bills. That’s one of the reasons we offer free case consultations. Your initial call or meeting with our firm is completely free, and we will investigate your potential Parietex™ mesh case without ever asking for money up front. If our investigation concludes we cannot pursue a claim for you, you never have to worry about receiving a bill from us.
Additionally, if we conclude we can pursue a claim on your behalf, we will generally advance the costs of doing so. We recognize most people cannot afford the large expenses associated with litigating a medical device lawsuit, so we assume that financial risk for you and contract our cases on a contingency fee basis. That means we only get paid if you get paid. If you do not receive a money award from your lawsuit, you will not owe us a cent.
Especially in the circumstances of Parietex™ mesh, when you are potentially filing a claim against a big medical corporation, the process can seem intimidating. But when you hire Stern Law, you can rest easy knowing we have the resources and experience to obtain the compensation you deserve. We regularly take on huge medical device corporations, and we never shy away from complex cases because we firmly believe in the justice of holding these manufacturers accountable. Together, we can make the industry safer for people in the future and make the road ahead easier for you and your family.
Current Hernia Mesh Litigation
The current environment of 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.
What Can I Recover in a Parietex™ Composite Mesh Lawsuit?
The team at Stern Law knows your Parietex™ Composite mesh injuries have changed your life, and we want to help you receive the compensation you need to move forward. When you file a claim for damages against Medtronic, you can recover for the various ways you have been harmed by your Parietex™ Composite mesh implant. This includes claims for the following types of damages:
- Lost wages, if you missed work or cannot currently work because of your hernia mesh injuries;
- Lost future wages, if you will not be able to return to work;
- Past medical bills for treatment related to your hernia 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 hernia mesh injuries.
As a client of Stern Law, you can feel confident that we will help you calculate the full extent of your economic and noneconomic damages. Our goal is to maximize the amount you and your family recover.
Stern Law’s attorneys pride themselves on accessibility, and we strive to maintain the best client communication possible. If at any time you have questions about your claim, you can contact our office and expect to receive answers as soon as possible. Your claim is important to us, and we want to make sure you are always assured as to the direction and progression of your claim. We know your Parietex™ injuries have already forced you to take valuable time out from your life, and we recognize you need a timely resolution.
Why Choose Stern Law for Your Claim?
When you’re dealing with an injury from a medical device, you want to be sure you have the right people on your side. At Stern Law, PLLC, we understand how product injuries, like those associated with Parietex™ Composite mesh, affect your life, and we work to take some of the stress off your shoulders. With more than 30 years’ experience litigating medical device cases, our attorneys know how to achieve the results you need while giving you the time and attention you deserve.
Though based in Michigan, our firm takes cases nationwide. We have a wide network of accomplished trial lawyers, and the nature of mass tort litigation like hernia mesh allows us to file and prosecute claims all across the country. When you hire our firm, one of our skilled product liability lawyers will immediately begin preparing your case by:
- Obtaining a detailed account of your surgical history and the injuries you have suffered from Parietex™ Composite mesh;
- Ordering all records from the day of your hernia repair surgery, including intraoperative notes and implant records to establish product identification;
- Ordering records documenting the additional surgeries and medical care you have received because of your Parietex™ Composite mesh injuries;
- Identifying the governing statute of limitations for your claim (the state-determined time during which you must file your lawsuit);
- Consulting with medical experts and industry experts to obtain support for your claim;
- Determining where your case should be filed (whether in Multidistrict Litigation or elsewhere);
- Drafting and preparing a petition for filing.
We know that all surgical procedures, including hernia repair, have risks. We know surgical implants themselves also have risks, and it is impossible to eliminate risk from device implantation altogether. But manufacturers have a legal obligation to adequately warn patients and the medical community about the risks associated with their products. At Stern Law, we hold the manufacturers accountable and strive to ensure our clients receive appropriate compensation for their injuries. In doing so, we achieve justice for our clients and work toward making the healthcare industry safer for people in the future.
At Stern Law, one of the most important aspects of our practice is client communication. Our lawyers are caring and compassionate professionals who recognize the value of keeping clients updated on the status of their claims.
In large-scale product litigation, it can sometimes feel like you’re lost in the shuffle. At Stern Law, our clients are people with stories, not case numbers or dollar signs. It is extremely important that we maintain excellent communication with our clients, so they always understand what work we’re doing on their cases and what they can expect in the near future.
Contact Stern Law, PLLC
Stern Law is committed to bringing you results during a time you need it most, starting with a confidential consultation at absolutely no cost to you. Our attorneys understand your injuries have changed your like, and we are committed to resolving your claims to help you move forward. If you or a loved one underwent hernia repair surgery using Parietex™ Composite mesh and developed postoperative complications, contact Stern Law, PLLC, at (844) 808-7529, to schedule a free consultation with one of our experienced lawyers.