This Covidien hernia mesh lawsuit article by an attorney focuses on Covidien Parietex hernia mesh as well as Covidien mesh lawsuits such as Parietex Progrip, Surgipro and Symbotex mesh. Many Covidien victims are seeking a Parietex surgical mesh settlement 2020. Other victims are wondering what the average hernia mesh settlement will be in the future. This article provides information to Covidien* hernia mesh victims who suffered mesh complications as a result of hernia repair and are considering filing a Covidien hernia mesh lawsuit
What you need to know about Covidien mesh lawsuits:
- If a Covidien hernia mesh lawsuit is filed after the statute of limitations, the lawsuit is subject to being dismissed by the Court
- Many victims mistakenly believe that a Covidien mesh recall is required to pursue a Covidien mesh lawsuit.
- There is no consolidated Covidien lawsuit but mesh lawyers are in settlement talks.
- Individual lawsuits possible for catastrophic injuries.
Covidien hernia mesh lawsuit update
4/23/20-update- There is currently no consolidated litigation in federal or state Courts for Covidien / Medtronic hernia mesh. Any lawsuits that have been filed are individual lawsuits filed in federal or state courts. Typically, only cases with well over a million dollars of damages are filed as individual lawsuits. Individual lawsuits are often prohibitively expensive because of the limitless resources of the manufacturers.
Certain lawyers are currently in settlement negotiations with Covidien. Covidien is attempting to work out a settlement with the mesh lawyers. The attorneys have agreed to hold off filing lawsuits while the parties are attempting to reach a hernia mesh settlement. The hernia mesh lawyers have, in many cases, entered into a tolling agreement with Covidien in which the parties agree to extend the statute of limitations for the victim while settlement talks are ongoing. Covidien may require a revision / repair surgery as a prerequisite to settling the claim.
A tolling agreement must be in writing and must be signed by both litigants in a potential lawsuit. A tolling agreement extends the statute of limitations for the amount of time expressly set forth in the agreement. According to unnamed sources, Covidien has settled some cases. *Covidien was formerly Tyco and is now Medtronic.
Many Covidien mesh victims are wondering:
- Is a Covidien mesh recall required to file a Covidien lawsuit?
- What you need to know before filing a lawsuit?
- Will there be a Parietex settlement 2020?
Types of Covidien hernia mesh we are reviewing:
- Surgipro Plug & Patch
- 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
- Parietene composite
- Parietene Macroporus
- Parietene Progrip
- Parietex Easegrip
Filing a Parietex hernia mesh lawsuit
If you are looking to file a Covidien hernia mesh implant lawsuit as a result of Parietex mesh contact a top surgical mesh law firm. No victim should have to bear the brunt of hernia mesh pain and side effects without the satisfaction of seeking justice and accountability from the mesh manufacturers. It is imperative that surgical mesh victims don’t miss a statute of limitation deadline for filing a lawsuit. If a Covidien hernia mesh lawsuit is filed after the statute of limitations, the lawsuit is subject to being dismissed by the Court. Many victims mistakenly believe that a parietex mesh recall is required to pursue a Covidien mesh lawsuit.
Parietex frequently misspelled
Victims are searching the worldwide web seeking information about Parietex mesh and it’s symptoms and complications. Some victims are even spelling the name of the mesh as “pariatex mesh” or “paratex mesh.” Hernia mesh law firms and industry insiders are well aware that the proper spelling is “Parietex mesh” not “pariatex mesh” or paratex. But we all know with google’s sophistication, the correct results will be found even if a victim types in “pariatex mesh” or “paratex mesh.
How does Covidien describe the Parietex?
“The Parietex™ composite ventral patch is a mesh specifically designed for small ventral hernia repair. The shape, size and the specific fixation and deployment system have been designed for optimal abdominal wall conformability and easy deployment and fixation. In addition to these technical features, Parietex™ composite ventral patch has been designed to support tissue integration while minimizing tissue attachments with collagen. The Parietex™ composite ventral patch offers a complete range of 3 product sizes (diameter: 4.6, 6.6 and 8.6 cm).” Medtronic
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 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.
What is the parietex mesh composition?
Many victims of parietex optimized composite mesh considering a mesh lawsuit are wondering what is the Parietex mesh material? According to propaganda set forth by Covidien, “Introduced in 1999, Parietex™ Composite (PCO) mesh was 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. Parietex™ Composite (PCO) mesh was ahead of its time and remains the standard that others strive to reach.” Covidien
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.
What is Covidien Progrip mesh?
- According to material drafted by Medtronic, Progrip mesh is described as follows: “Designed to address key issues in laparoscopic inguinal hernia repair, ProGrip™ laparoscopic self-fixating mesh delivers tack-free fixation over the entire anatomy, including below the inguinal ligament where traditional tacks cannot be placed.
- “Increases the security of the laparoscopic inguinal hernia repair.”
- “Eliminates the pain associated with traditional tack fixation.’
- ‘Is easy to use and faster than tacks.”
- “Lowers the cost of the laparoscopic inguinal procedure by combining the functionality of mesh and fixation into one device.” medtronic
New victims may bring Covidien hernia mesh lawsuits
New victims continue to file claims against Covidien, as they realize the damages that they’ve suffered because of mesh products. The large settlement reached in the Kugel hernia mesh MDL in 2011 is a 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. Despite the public awareness many people still misspell Parietex mesh as: “paratex mesh” or “Pariatex hernia mesh.”
Jason Bruce V. Medtronic and Covidien, LP
Below you will find information about a recent hernia mesh 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.
Allegations by the victim:
- 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 (parietex 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)
Kimberly Pellegrin lawsuit against Covidien
On November 14, 2017 Kimberly Pellegrin filed a hernia mesh lawsuit against C.R. BARD, DAVOL, INC., MEDTRONIC, INC., AND COVIDIEN, LP in the UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF LOUISIANA. Ms. Pellegrin alleged in pertinent part:
- “On October 25, 2014, Plaintiff was rushed to Leonard J. Chabert Medical Center in Houma, Louisiana, wherein she was diagnosed with a perforated duodenal ulcer. Plaintiff was also suffering from tachycardia, hypotension, sepsis, acute kidney injury, abnormal coagulation profile and gastrointestinal bleeding. Plaintiff underwent an ex-lap with primary repair of duodenal perforation and omental patch. During the operation, Plaintiff was implanted with the Products and Parietex Composite Mesh (i.e., “the Product”), products designed, manufactured, marketed, packaged, labeled, sold, and placed in the stream of commerce by Defendants.” Id.
- “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.”Id.
- “Additionally, Plaintiff has undergone subsequent surgeries to remove and/or repair the damage and injuries caused by the Products.” Id.
- “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. Read the parietex surgical mesh complaint here
Mary Lacassin v. Covidien
On January 12th, 2018 Mary Lacassin filed a Covidien hernia mesh lawsuit against Covidien LP and Medtronic Inc. as a result of allegedly defective Parietex mesh implanted in her body. This mesh lawsuit was filed in UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF LOUISIANA LAFAYETTE DIVISION. In this Parietex lawsuit she alleges misrepresentations by Covidien as to the safety of the hernia mesh.
In pertinent part, she alleges “Parietex Composite Mesh was unreasonably dangerous as well as defective and likely to cause severe complications.” She further alleged that Covidien “maximize sales and profits at the expense of the health and safety of the general public and Plaintiff.” MARY LACASSIN V. COVIDIEN LP AND MEDTRONIC, INC. COMPLAINT
She did not stop there. She made very serious allegations that “Covidien and Medtronic acted in conscious disregard for the foreseeable harm caused by Parietex Composite Mesh in not adequately warning the FDA, the general public, the medical community, or Plaintiff of the numerous side effects, complications, and contraindications of Parietex Composite Mesh.” id. She further alleged that “Contrary to the representations of Covidien and Medtronic, Parietex Composite Mesh has a high rate of failure, injury, and complication; fails to perform as intended; and causes severe and irreversible injuries like those suffered by Plaintiff.” id.
Allegations in Mary Lacassin’s Covidien hernia mesh lawsuit
- “Plaintiff is an individual of the full age of majority domiciled in Saint Landry Parish, Louisiana, who was injured as a result of receiving defective hernia mesh researched, designed, developed, tested, manufactured, labeled, packaged, promoted, advertised, marketed, supplied, sold, and/or distributed by Defendants.” MARY LACASSIN V. COVIDIEN LP AND MEDTRONIC, INC. COMPLAINT
- “Defendants conducted substantial business through the distribution of surgical mesh products as well as received significant compensation and profits from sales of surgical mesh products in Louisiana and the Western District of Louisiana. While conducting substantial business in Louisiana and the Western District of Louisiana, Defendants also made material misrepresentations and omissions of fact with regard to the effectiveness, safety, risks, side effects, contraindications, and complications related to surgical mesh products. In addition, Defendants directly or indirectly promoted, advertised, marketed, supplied, sold, and/or distributed surgical mesh products in Louisiana and the Western District of Louisiana.” id.
- “In approximately November of 2011, Plaintiff underwent surgery to repair a hernia and Parietex Composite Mesh was implanted during the surgery.” id.
- “As a result of the implantation of the unreasonably dangerous and defective Parietex Composite Mesh, Plaintiff suffered injuries including, but not limited to, scarring, pain, recurrence, and additional surgery.” id.
- “The absorbable collagen barrier on the visceral side of Parietex Composite Mesh fails to protect the body from the hydrophilic three-dimensional polyester textile on the parietal side because the absorbable collagen barrier breaks down after coming in contact with moisture and tears easily during handling. The composition of polyester is also weak and Parietex Composite Mesh is known to unravel causing the polyester fiber to detach and travel to other parts of the body inciting an inflammatory response. Parietex Composite Mesh further contracts over time causing tension to increase where secured by tacks and sutures resulting in tearing.” id.
Federal Judge dismisses Parietex mesh lawsuit
“NEW ORLEANS — A Louisiana federal judge has dismissed a lawsuit involving Covidien Parietex Composite hernia repair mesh, ruling that while there is a question as to whether the claims are time-barred, the plaintiff failed to specify how the product was defective, or how it caused her injuries. However, in the June 20 order, Judge Sarah S. Vance granted the plaintiff leave to amend her complaint to replead her claims of defective construction or composition, inadequate warning, design defect, and breach of express warranty” Harris Martin
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.
Who is medtronic?
“MEDTRONIC, INC. (“Medtronic”) is a for-profit corporation organized under the laws of Minnesota with its principal place of business in Minnesota at 710 Medtronic Parkway Northeast, Minneapolis, Minnesota 55432.” MARY LACASSIN V. COVIDIEN LP AND MEDTRONIC, INC. complaint
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
- 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)
Lawsuit components – defect, 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 Covidien hernia mesh 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.
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.
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.
“According to the FDA, the most common complications following hernia mesh surgery include:
- Adhesions (mesh sticking to intestines)
- Autoimmune reactions to mesh
- Bowel or intestinal blockage
- Fistulas (abnormal connections between organs)
- Hernia recurrence
- Mesh migration and rejection
- Mesh shrinkage
- Nerve damage
- Organ perforations
- Pain & bleeding
- Seroma (fluid buildup at the surgery site)
- Tenderness at the implant site” Drug watch
Many mesh victims are asking legitimate questions such as:
- What are hernia mesh failure symptoms?
- What are hernia mesh failure symptoms?
- Was there ever a parietex mesh recall?
- Why was there no parietex mesh recall?
- Can I file a Covidien 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 (hernia recurrence), 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 Covidien hernia mesh lawsuit lawyer will fight to protect the rights of victims of medical devices.
What types of hernias was the mesh used to repair?
Covidien/Medtronic hernia-repair mesh has been used for many types of hernia repair. Common examples include inguinal, incisional, femoral, umbilical, and hiatal hernias. Regardless of the hernia type, people injured by the defective mesh are owed compensation.
What should I do if I suffered from a defective hernia mesh?
It’s critical to become part of the ongoing lawsuits against Covidien/Medtronic. Many hernia patients are involved in the litigation. If you or a loved one have been injured by defective hernia repair mesh, contact our office now. There are no upfront fees or out-of-pocket costs. Settlement negotiations may take place, and we want to make sure you get all of the compensation you are entitled to receive.
Hernias are caused by the protrusion of organ or fatty tissue through a weak point in the fascia. Fascia is the muscular and connective tissue that surrounds organs and other tissues. Anyone can experience a hernia, though men and older people are more at risk. ” A hernia is the protrusion of an organ, organic part, or other bodily structure through the wall that usually contains it.” Webster’s II New College Dictionary. Boston, MA: Houghton Mifflin Company; 1999;519, ncbi 1.
Medtronic which was formerly Covidien manufactures numerous types of Parietex hernia mesh. Many victims have suffered severe complications, symptoms and side effects as a result of this hernia mesh device. Many hernia mesh law firms are pursuing Parietex mesh lawsuits against Medtronic alleging that the surgical mesh is defective and unsafe. These mesh law firms are seeking compensation, damages and justice on behalf of Parietex mesh victims. These lawyers are seeking lucrative hernia mesh settlements on behalf of their clients.
What causes a hernia?
An increase in pressure from an organ and a weakness in the fascia is always the cause of a hernia. Some hernias are genetic and can be present at birth. Most often, an increase in pressure from the abdomen causes the hernia. Increased pressure that causes hernias commonly occurs from constipation and diarrhea, lifting heavy objects without stabilizing the abdominal muscles, and severe and persistent coughing or sneezing. Obesity also increases the likelihood of a hernia. Lifestyle choices, such as smoking or poor diet, can also increase hernia risks by contributing to the weakening of the abdominal wall.
“Common causes of muscle weakness include:
- failure of the abdominal wall to close properly in the womb, which is a congenital defect
- chronic coughing
- damage from injury or surgery” Healthline
“Factors that strain your body and may cause a hernia, especially if your muscles are weak, include:
- being pregnant, which puts pressure on your abdomen
- being constipated, which causes you to strain when having a bowel movement
- lifting heavy weight
- fluid in the abdomen, or ascites
- suddenly gaining weight
- surgery in the area
- persistent coughing or sneezing” Id.
When hernias become problematic, doctors perform surgery to repair the weak fascial point. Hernias often result in tissue poking through the weak point when a person bends or makes another motion. The tissue then pops back into its proper place when the patient lies down. Often, if the patient experiences no adverse effects, such as pain and reduced mobility, he or she will choose not to fix the hernia unless it becomes problematic. When hernias become problematic, doctors perform surgery to repair the weak fascial point. The repair involves insertion of a mesh into the fascia. After the surgery, the body’s tissue grows around the mesh, creating a barrier strong enough to contain the organ of fatty tissues.
Restrictions after a hernia surgery
The choice to delay the surgery often stems from the side effects and complications of the surgical procedure. Though many patients are able to have hernia surgery on an outpatient basis, the patient remains restricted from lifting heavy objects and making certain movements for several months afterwards. During this time period, the hole in the fascia remains in the process of closing. Lifting a heavy object, for example, could cause the hole to rupture once again, requiring another surgery.
Medtronic hernia mesh
Surgeons obtain hernia repair mesh from medical manufacturers, such as Covidien, now known as Medtronic. Unfortunately, some Covidien/Medtronic hernia repair mesh has been defective. As a result, many patients who have had Covidien/Medtronic mesh insertions have experienced severe complications that are not a normal result of hernia surgery. The complications are allegedly a result of product defect.
Over the past several years, the Food and Drug Administration has received numerous complaints about Covidien / Medtronic’s entire line of hernia repair mesh. As a result, numerous lawsuits have been filed against Covidien/Medtronic. Patients have suffered numerous complications as a result of the allegedly defective hernia mesh, which Covidien / Medtronic has failed to adequately address.
Some of the serious complications experienced by patients treated include:
- Chronic Pain
- Adhesions, often resulting in scar tissue
- Bowel obstruction
- Intestinal blockage
- Mesh tearing
- Mesh erosion
- Mesh migration
- Mesh folding
- Intestinal fistula
- Spermatic cord injuries
- Testicular Ischemia
- Hernia recurrence
None of these complications are a result of hernia surgery. These complications result from a defective mesh product, which ultimately can hurt the patient more than it helps the patient. These are serious injuries resulting from an alleged product design flaw. These injuries result in severe suffering and debilitation.
Injuries from the defective mesh are also horrendously difficult to remedy. Because the mesh has grown into the tissues, removal is exceptionally complicated. Surgeons must carefully remove the encapsulated mesh from living tissue. This often cannot be done without causing some degree of additional pain and injury. In many cases, the mesh cannot be completely removed, resulting in patients having mesh fragments permanently stuck in their bodies.
“The factors that increase your risk of developing a hernia include:
- a personal or family history of hernias
- being overweight or obese
- a chronic cough
- chronic constipation
- smoking, which can trigger a chronic cough” Healthline
Types of defective hernia repair mesh made by Covidien
Alleged design flaws and subsequent injuries occur across the entire Covidien / Medtronic hernia mesh product line. These mesh products are made from synthetic polypropylene and polyester. The tiny holes contained in the mesh allow surgeons to push the herniated material back in place, while reinforcing the weakened tissue wall.
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). Maude report