This hernia mesh article by an attorney focuses on Covidien Parietex hernia mesh as well as hernia mesh lawsuits in general.This defective medical device product liability article pertains to pending litigation, lawsuit history as well symptoms and complications from such mesh.
Types of Covidien hernia mesh we are reviewing for lawsuits:
Covidien: (Formerly Tyco):
Parietex Parietex Composite Ventral Patch, Parietex ProGrip Self-Fixating Mesh Parietex Optimized Composite Mesh Parietex Plug and Patch System Parietex Composite Open Skirt (PCO OS) Mesh Parietex Optimized Open Skirt Mesh Parietex Composite Parastomal (PCO PM) Mesh Parietex Composite Hiatal Mesh (PCO 2H) Parietex Hydrophilic Anatomical Mesh Parietex Folding Mesh Parietex Flat Sheet Mesh Parietex Lightweight Monofilament Mesh
Some FDA adverse event reports for Parietex:
- Event date: 06/01/2011 Type of device: PARIETEX COMPOSITE MESH, Event Description: Procedure type: hernia. According to the rptr: during a re-operation, it was noticed that the mesh had a hole. The bowel was incarcerated through the hole in the mesh. The doctor stated that the suture stayed in the fascia and then pulled through the mesh. CatalogS Number
- Event Date: 04/30/2012 Type of Device: PARIETEX COMPOSITE MESH, Event Description: According to the reporter: the customer reports that a pt, on whom the device has been applied some time ago, had to be re-operated. During the procedure, the surgeon found out that the intestine was sticking on the whole surface of the mesh. Catalog Number: PCO3020F
- Event Date: 06/22/2009 Type of Device: PARIETEX COMPOSITE MESH, Event Description: Procedure type: hernia. According to the reporter: as patient was coming out of anesthesia, the patient tore out the product from the suture half at the fascia side as well as 3cm. The surgeon removed the product and used a c-quin mesh. Catalog Number: PCO3728
- Event Date: 03/22/2011 Type of Device: PARIETEX COMPOSITE MESH Event Description: Mesh product implanted during surgery for incisional hernia on (b)(6) 2011. Product split almost entirely in half and pt was returned to surgery on (b)(6) 2011 for removal and surgical repair. Catalog Number: PIF00365
- Event date: 07/13/2011 Type of device: COVIDIEN PARIETEX PROGRIP Event Description: Pt called to report adverse reactions to covidien paritex progrip, which he had implanted on (b)(6) 2011, due to an inguinal hernia. Pt stated since implantation of the parietex progrip mesh, he experiences constant pain in his right testicle. He also stated he has severe pain starting in his right groin up to his belly button. He also experiences pain down the inside of his leg to the bottom of his foot. Pt also says he often feels an “electrical jolt” feeling between his testicle and leg, on the back of his knee, and where the pain ends up through his groin. He stated his lower abdominal area is also in constant pain and has spasms. Pt says he received no warning from his doctor or surgeon of possible adverse reactions or side effects, he was only told there is a 2% chance of reoccurrence. His everyday living has been severely impaired and he says he is basically disabled due to constant pain. Pt is concerned the mesh is possibly poisoning him since it’s made of polyester. He said he used to do auto body work and painted cars for 13 yrs, and was very used to things with “poly” in them. Now, he claims the smell of anything with “poly” in it makes him sick. He stated he takes pain medication, but it doesn’t really help. He says his sleep is disrupted, he sleeps very little due to pain, and the little amount of sleep causes some anxiety for him. He said he had the mesh implanted at (b)(6). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2943724
JASON BRUCE V. C.R. BARD, MEDTRONIC, INC., AND COVIDIEN, LP
Below you will find information about a recent lawsuit against three companies related to Parietex Progrip Mesh .
This lawsuit was filed by a Louisiana resident in the U.S. District Court for the Eastern District of Louisiana. According to the hernia mesh lawsuit, “His preoperative diagnosis was right inguinal hernia.” This product liability defective medical device lawsuit alleged that Parietex Progrip Mesh was defectively designed, dangerous and unsafe.
The victim alleged numerous complications as well as pain and suffering. He alleged that the complications were caused by the mesh. The defendants were C.R. Bard, Davol, Medtronic Inc. and Covidien. The hernia mesh victim acting by and through a top hernia mesh Plaintiff’s lawyer asserted that “Defendant, Covidien, LP, (“Covidien”) is a Delaware Limited Partnership and a subsidiary of Defendant, Medtronic, headquartered in Mansfield, Massachusetts.” Bruce v Medtronic Complaint.
Here are some of the allegations made by the hernia mesh victim, Jason Bruce, against the mesh manufacturers:
- The Plaintiff alleged that Bard, Davol and Medtronic, “design, manufacture, market, package, label and sell medical devices, including a medical device known as the Parietex Mesh, a medical device implanted to treat persons like Plaintiff for hernias (also referred to as the “Covidien Product”)”
- Surgeons performed “a repair of the hernia with mesh, plug and patch technique” utilizing Parietex Progrip Mesh.
- According to the Parietex hernia mesh attorneys, “Due to defective design, defective manufacturing, defective construction/composition, inadequate warning, breach of express warranties, improper marketing, negligent marketing, and negligence by Defendants, the Product has caused Plaintiff severe and permanent bodily injuries, including but not limited to excruciating abdominal pain and swelling, difficulty walking, and physical pain and suffering, and economic losses.”
- “Additionally, Plaintiff will have to undergo subsequent surgeries to remove and/or repair the damage and injuries caused by the Products”
- The Parietex hernia mesh lawyers asserted that “The product has numerous defects that create a high risk of unreasonable and dangerous injuries and side effects with severe permanent adverse health consequences including that the material in the Product abrades tissues adversely affecting patient health and regularly fail to perform the purpose of its implantation such that the patient requires repair and/or removal of the Product and repeated treatment and surgery.” Id. (Complaint authored by some of the best hernia mesh lawyers in the Unites States)
Parietex Hernia Mesh Lawsuit Problems with mesh devices – complications and symptoms
Hernia mesh victims report a variety of physical problems associated with mesh use. Mesh devices can cause pain and infection.
Victims have reported recurrence of the hernia, adhesion of the mesh to body parts and obstruction and perforation of the bowel. All of these difficulties and complications can be life threatening. Many of the Parietex mesh devices allegedly pose specific problems in that they’re not all made of polypropylene like other mesh devices.
The hernia mesh attorneys representing the manufacturer is looking to delay, duck, defend and deny liability for their defective, dangerous and unsafe medical device product. A Parietex hernia mesh attorney will fight corporate America relentlessly to get the victim Justice, compensation and restitution. A Parietex mesh lawyer will fight to protect the rights of victims of medical devices.
Many Parietex devices are made of polyester. The polyester is soft and flimsy compared to similar products made of polypropylene. This polyester causes a more severe inflammatory response than other mesh products produce. Victims report severe adverse reactions when the polyester devices are placed across the bowels. Although Parietex responded to the problems by applying coatings to cover the polyester in some cases, these coverings are often just as dangerous and result in the same or even worse complications.
A hernia mesh lawyer or a mesh attorney at a large product liability law firm with experience litigating medical device lawsuits will help aggrieved victims get the settlement or judgment that they are entitled to.
In addition, Parietex mesh products often have unsealed edges. These edges can perforate the bowel. They can also fray and unravel in the body. When they fray, they can cause tearing. This causes recurrence of the original malady in addition to other problems.
In many cases, when an infection occurs, it’s not possible to treat the infection without removing the mesh. To remove the mesh, the surgeon has to take a significant portion of a person’s live tissue along with it. This can result in further complications and problems in an area where the patient is already dealing with the original injuries.
Symptoms not immediately recognized
Part of the problem with complications from mesh use is that the problems are not always readily apparent after a procedure. A mesh may not malfunction immediately, or a patient may not immediately recognize symptoms. An infection might take days, months or even years to show. This can pose a challenge for victims who might not know about their adverse event until years after they receive a mesh.
Training medical professionals to recognize complications
Too often, device Manufactures train professionals and surgeons only on the benefits of the mesh and how to use the product. In many cases, this training woefully fails to include how to recognize adverse reactions in patients. Treatment providers might tell victims that their symptoms are mental. They’re told that they have depression. Hernia mesh victims say that this lack of education for medical professionals has led to too many doctors and surgeons being trained to purchase and insert the devices and too few doctors trained to help patients who have an adverse reaction after the fact.
Types of Covidien Parietex mesh
• Parietex – The family of mesh products that Covidien produces and sells to surgeons and other health-care providers.
• Parietex Composite Ventral Patch – A small patch meant for hernia repair, primarily of the abdominal wall. There are three sizes on the market.
Trade or proprietary name: Parietex Composite Ventral Patch
Common or usual name: Surgical Mesh
Classification name: Mesh, Surgical, Polymeric
Classification panel: General and Plastic Surgery (79)
Regulation: 21 CFR 878.3300
Product Code: FTL
Legally marketed devices to
which equivalence is claimed: Parietex Tm Composite Mesh (K040998)
Bard Ventralex® Patch (K021736 and K<024008) (FDA)
• Parietex ProGrip Self-Fixating Mesh – This mesh has micro grips, and it’s partially absorbable. It comes in a rectangular shape or pre-cut to fit the groin. “ProGrip(TM) Laparoscopic Self-Fixating Mesh – Seamlessly combines mesh and fixation into one device to increase the security of laparoscopic inguinal hernia repair, while eliminating the pain and reducing the costs associated with tack fixation.” Business Wire
Read FDA 510(k) approval letter for Parietex ProGrip Self-Fixating Mesh, Parietex™ Plug and Patch System and ProGrip™ Laparoscopic Self-Fixating Mesh
• Parietex Optimized Composite Mesh – A mesh with a high number of tcks and large pores. 510(k) Summary of Safety and Effectiveness
Name of device
Trade or proprietary name: PARIETEX Optimized Composite Mesh
Common or usual name: Surgical Mesh
Classification name: Mesh, Surgical, Polymeric
Classification panel: General and Plastic Surgery (79)
Regulation: 21 CFR 878.3300
Product Code: FTL
Legally marketed devices to
which equivalence is claimed: PARIETEXT Composite Mesh (K002699 and K040998)
Dermalon® suture (K930586)
BIOMESH® C.A.B. S Air (K072962) (Id)
• Parietex Plug and Patch System – A surgeon must place this mesh correctly on the first try. It has high infection rates, and the patient must have it removed if it becomes infected.
DATE PREPARED: May 28, 201 0
TRADE/PROPRIETARY NAME: PARIETEX Plug and Patch
COMMON/USUAL NAME: Surgical Mesh
CLASSIFICATION NAME: Mesh, Surgical, Polymeric
PREDICATE DEVICE(S): BARD” MESH PERFIX6 PLUG (K922916)
PARIETEX PROGRIP Mesh (K081 050)
PARIETEX Tm Lightweight Monofilament Polyester Mesh (K090858)
PARIETEX PARASTOMAL MESH (K081126) (from 510k summary)
• Parietex Composite Open Skirt (PCO OS) Mesh – While Covidien markets this mesh for incision and hernia repair, its polyester components can cause complications including infection.
• Parietex Optimized Open Skirt Mesh – Covidien markets this type of mesh as more resistant to damage than its Composite products.
• Parietex Composite Parastomal (PCO PM) Mesh – This type of mesh has unsealed edges that are prone to tearing and unraveling.
• Parietex Composite Hiatal Mesh (PCO 2H) – A mesh that’s primarily for use around the esophagus.
• Parietex Hydrophilic Anatomical Mesh – Designed to cover specific body parts, this mesh is macroporous.
• Parietex Folding Mesh – This product contains a suture.
• Parietex Flat Sheet Mesh – These meshes look rectangular or square in shape. They come in a variety of sizes. Complications with this type of mesh are many of the typical problems associated with Parietex products.
• Parietex Lightweight Monofilament Mesh – While this mesh is lighter weight than some of Covidien’s other products, it has many of the same complications.
FDA approval info: K142908
Trade/Device Name: Parietex™ Lightweight Mesh
Regulation Number: 21 CFR 878.3300
Regulation Name: Surgical mesh
Regulatory Class: Class II
Product Code: FTL
Dated: October 7, 2014
Received: October 8, 2014 (510 k summary)
Hernia mesh Lawsuit history – claims, verdicts and settlements
Complaints about all different types of mesh products began in the mid 2000s. The Food and Drug Administration (FDA) received more than 1,000 reports of hernia mesh adverse events between 2005 and 2008. While they initially passed off the problems as rare, by 2011, they admitted that the products pose a serious and ongoing problem for victims across the country. As problems with hernia mesh products grew more apparent in the 2000s, victims began to bring legal cases for recovery.
Hernia mesh law firm with some of the best hernia mesh lawyers began preparing lawsuits to get compensation for victims.
In total, C.R. Bard has faced more than 11,300 suits in the past decade as a result of different types of mesh. These lawsuits cover not only Parietex products but also other mesh products that have caused severe damages to unsuspecting victims. Victims began to receive large jury verdicts as the cases went to trial.
In one case, a victim received a $20 million verdict against Johnson and Johnson for damages from a mesh product. In a 2012 case, a victim recovered $5.5 million. In a 2013 case, the victim recovered $2 million. These cases involved mesh products produced by other companies. However, the vast majority of the verdicts have been overwhelmingly positive for victims of all mesh products regardless of the producer.
“In 2011, C.R. Bard paid $184 million to settle more than 2,600 lawsuits filed in a Rhode Island multidistrict litigation for their Kugel Hernia Mesh.” https://www.classaction.com/hernia-mesh/settlement/
As these verdicts began to come down against C.R. Bard and other companies, C.R. Bard began to explore large-scale settlement of groups of claims. They saw settling the cases en masse as the only way to avoid bankruptcy. To that end, C.R. Bard authorized two large-scale settlements of claims. The first occurred in October, 2014. That settlement resolved approximately 500 cases. The company agreed to pay $21 million or approximately $43,000 per claim. The company authorized the second settlement in August, 2015. The settlement resolved approximately 11,000 cases.
Although the terms are confidential, the settlement set aside approximately $200 million to pay victims approximately $67,000 each. Because of the sheer number of victims in involved, the U.S. courts consolidated many cases in federal court in West Virginia. Other cases continue in state courts across the country. Cases continue to pour into American courts as victims continue to realize the extent of their injuries and damages. Plaintiffs appear to have strong cases. C.R. Bard appears to recognize the strength of the cases and pursue settlement.
Lawsuit components – defective product, failure to warn, breach of warranty
Most of these lawsuits contain a number of counts. Specifically, many of the lawsuits include allegations of defective construction. That is, they state that the mesh companies made their products unreasonably dangerous for the user, or that they could have designed the products in a better way. The lawsuits also contain allegations that the company failed to adequately warn doctors about the dangers of the products. They say that proper warnings would have led doctors to make other choices for products or more quickly recognize adverse events. Finally, many of the lawsuits allege that mesh manufacturers breached their implied warranty to patients that their products were adequate and fit for use.
501(k) approval process and criticisms
Surgical mesh products are supposed to work as internal organ support for patients who suffer hernias and other organ misplacement. However, patients have quickly learned that these products often cause infections, obstructions and pain, or they simply fail. These defective products have caused tens of thousands of legal claims as patients work to recover fair compensation and rebuild their lives. Medical device producer Covidien manufactures the Parietex brand of mesh devices.
How a mesh medical device works
A mesh is a medical device that physicians use to treat conditions in the body. Most often, a mesh helps internal organs stay in their proper place. Today, most meshes are made of polypropylene. This is a polymer that’s used in many other applications like food storage containers, plastic chairs and lab equipment.
Because many Parietex meshes use polyester and other components in addition to and in place of polypropylene, their meshes are alleged to be particularly susceptible to infection. A mesh can be a permanent implant, or the body can absorb it over time. If a mesh is absorbable, it means that the body breaks down its materials, and the mesh disappears over time. It can also be non-absorbable. That means it stays in the body forever as a permanent implant. Medical professionals created the mesh to treat hernias.
What is a hernia?
A hernia occurs when an organ or tissue bulges through an abnormal opening. For example, if a part of your intestine or your bladder pokes through the intestinal wall, that’s a hernia. There are several different types of hernias. They’re classified based on where they happen in the body and how they occur. One type of hernia is an incisional hernia. It occurs because of a cut or a scar in the abdomen. This can be a complication that occurs because of a cut during surgery. When this type of hernia occurs, surgeons often turn to a mesh product to support the organ.
How do medical professionals treat a hernia?
When a hernia occurs, a medical professional evaluates the patient to see if the hernia causes the patient pain. If there’s no pain and the hernia itself isn’t likely to cause further problems or complications, the professional may advise the patient to simply monitor the hernia for comfort and future problems. In the majority of cases, a hernia requires surgery. The surgeon uses either sutures to close the wound, or they use a surgical mesh. In most cases, they use a mesh. Sutures are most appropriate for small hernias and infants, while a mesh is most common for adults and larger hernias. When choosing a mesh, a surgeon must consider its materials, the strength of the fabrics, its size and its pores. When a mesh is inherently defective, the patient can suffer an adverse reaction regardless of the physician’s care during implantation.
History of mesh use
Mesh use dates back to 1946. Developers originally designed mesh products to repair hernias, but they have since spread to vaginal use for incontinence and related pelvic organ shifting. In the early days, a mesh was made of metal which was typically stainless steel or tantalum. Early mesh devices commonly led to wound infections and chronic draining of the wound through sinuses in the mesh. These problems led to abandonment of metal mesh use by 1970. A physician first published use of a polypropylene mesh in 1958.
By the 1980s, the use of mesh to repair hernias became popular once again. By the 2000s, more than 90 percent of groin hernia repairs utilized a mesh device. Only this time, physicians used meshes made of polyester or polypropylene. Very quickly after they became popular, patients began to report pain and other negative effects from these devices. The Food and Drug Administration began to collect records of adverse events. From these events, lawsuits from victims have grown exponentially.
Today, mesh lawsuits comprise one of the largest mass tort claims in American history. Despite known problems, mesh devices continue to remain on the market, and device manufacturers continue to market their use to doctors for widespread use on unwitting patients.
Covidien company history
Covidien is based in Ireland, but its roots date back to a Massachusetts textile mill in 1903. The mill produced cotton balls and later a range of health and hygiene products. The company merged with other medical device companies, until Tyco International acquired it and named it Covidien in 2007. The company now operates in 150 countries with more than 39,000 employees. Covidien produces a wide range of surgical products, medical supplies and respiratory products. The Parietex mesh products comprise a significant portion of the company’s business. In addition to problems with Parietex mesh products, Covidien’s line of products have been the subject of many other product recalls. To date, the company has recalled approximately a dozen different products in 2017 alone. The company has recalled other products in prior years.
New victims may bring claims
New victims continue to file claims against Covidien and C.R. Bard, as they realize the damages that they’ve suffered because of mesh products. The large settlements that have occurred to date are a positive sign that future victims have a path to receiving fair compensation for the injuries they suffer because of Covidien’s defective products. Lawsuits are likely to continue into the future as public awareness grows about the dangers associated with Covidien Parietex mesh products.