Defective hernia mesh implants have sparked lawsuits nationwide. Thousands of medical device reports detailing adverse health effects related to failing hernia mesh devices flooded the FDA’s database, leading to numerous recalls between 2005 and 2019. Consequently, the increasing number of hernia mesh claims has spawned several multidistrict litigations (MDLs) regarding injuries attributed to various mesh complications.
About Hernia Mesh Lawsuits
A hernia occurs when an organ or fatty tissue protrudes through a weakened area in the surrounding muscle or connective tissue. While there are several types, hernias in the abdomen or groin area are the most common. Hernias can range in severity, but many require surgical intervention to correct the issue.
A hernia mesh, sometimes called a surgical mesh, is a medical device that supports the damaged tissue around the hernia as it heals. Although repairs can be performed without a mesh, surgeons use hernia mesh implants in 9 out of 10 hernia surgeries annually in the U.S. because they allow for a speedier surgery and recovery time.
Hernia mesh implants have steadily increased in popularity since the 1980s, but these devices have a long history of problems. Since 2005, several manufacturers have issued major recalls concerning faulty hernia mesh devices, affecting thousands of patients nationwide.
Those injured by hernia mesh implants have filed lawsuits for defective designs and failure to warn patients about the possible risks.
Manufacturers Involved in Hernia Mesh Lawsuits
Hernia mesh implants are available in several designs and materials to accommodate the various types of hernias and their placement. Depending on the hernia, a patient may receive a mesh patch to go over or under the damaged tissue, a mesh plug to fit inside the hole of the affected tissue, or a customizable mesh sheet to cover a hernia of a unique size. Manufacturers use different materials to construct hernia mesh implants, including synthetic materials like polypropylene (a form of plastic) or animal tissue.
With a market value of $4.5 billion in 2021, the hernia mesh market is highly lucrative and has attracted countless manufacturers. Below is a chart detailing manufacturers and their specific hernia mesh models.
|
Manufacturer |
Hernia Mesh Product Line |
| Atrium (a subsidiary of Getinge Group) | C-Qur, ProLite, ProLoop |
| Bard (a subsidiary of Davol) | 3DMax, 3DMax Light, Composix, Composix E/X, Composix Kugel, Kugel, Modified Kugel Patch, Parastomal Patch, Perfix Light, Perfix Plug, Sepramesh IP Composite, Ventralex, Ventralight, Ventrio, VentrioST, Visilex |
| Covidien (a subsidiary of Medtronic) | Parietene, Parietex, Permacol, ProGrip, Surgipro, Symbotex |
| Ethicon (a subsidiary of Johnson & Johnson) | Physiomesh, Proceed, Prolene, Ultrapure, Ultrapure Advanced, Vicryl, XCM Biologic, FlexHD Structural |
| Gore | DualMesh, Micromesh, Gore-Tex Soft Tissue Patch, Sinecure |
Complications Linked to Hernia Mesh Devices
While a hernia mesh is intended to improve the chances of a successful outcome, patients have reportedly suffered severe and even life-threatening complications.
The FDA has closely monitored problems surrounding hernia mesh implants. The agency has combed over medical device adverse event reports and peer-reviewed scientific literature to identify the most reported complications connected to these devices, including pain, infection, hernia recurrence, adhesion, bowel obstruction, and organ perforation.
Adhesion
Scar tissue is a normal part of the body’s healing process. However, in the event of an adhesion, scar tissue forms and connects the mesh to tissue or organs. Adhesions may not result in further complications, but sometimes adhesions can leave patients with chronic abdominal and pelvic pain, digestive problems, tissue death, difficulty urinating, and bowel obstruction.
Organ Perforation
Hernia mesh failure can cause organ perforation. A defective hernia mesh may erode and move inside the body over time, eventually poking holes in neighboring internal organs. Those who experience organ perforation should seek medical attention as it is a serious and life-threatening condition that can culminate in sepsis and even death.
Bowel Obstruction
Like organ perforations, bowel obstructions are a dire and potentially fatal hernia mesh complication. A bowl obstruction is an intestinal blockage that can restrict blood flow and cause tissue death in the intestine. Surgeons may have to remove a portion of the intestine if a hernia mesh causes a bowel obstruction.
Hernia Recurrence
Some hernia mesh implants, such as non-absorbable ones, are supposed to last permanently. Absorbable hernia mesh devices will degrade over time, but they are intended to reinforce the hernia repair by promoting new tissue growth.
Hernias naturally have a high recurrence rate. However, a defective hernia mesh increases the chance of recurrence, forcing patients to undergo painful and costly corrective surgeries.
Timeline of Hernia Mesh Recalls
Between 2005 and 2019, manufacturers recalled over 211,000 units of hernia mesh implants. Most of the recalls announced by the FDA were Class 2 recalls, meaning the product may cause temporary or medically reversible adverse health consequences. Yet, the FDA labeled Bard’s Kugel Patch recall a Class I recall. This classification is the FDA’s most severe type of recall as it is reserved for products with a reasonable probability of adverse health consequences or death for users.
Composix Kugel Mesh Patch Recall
Bard began recalling its Composix Kugel Mesh Patch devices in 2005. The company initiated the recalls due to a defect in the mesh that could cause it to break and create bowel perforations, fistulas, and other serious complications. The company issued several recalls for its Kugel patch from 2005 until 2007, resulting in over 130,000 devices being recalled.
Ethicon Proceed and Physiomesh Recall
Ethicon, a subsidiary of Johnson & Johnson, first recalled its Proceed surgical mesh in 2006 over reports of adhesions and fistulas. The FDA noted that the mesh could lose its coating over time because of a packaging issue that compromised its sterility. Without its coating, the mesh could stick to the surrounding tissue. The 2006 recall affected 18,000 devices, and Ethicon recalled the Proceed mesh again in 2010 and 2016.
The company also recalled its Physiomesh Flexible Composite in May 2016 after reviewing unpublished data that revealed high recurrence and corrective surgery rates for the Physiomesh compared to other mesh products.
Atrium Medical Corporation C-Qur Mesh Recall
The FDA sent a letter to Atrium in 2012, warning the company that it did not properly sterilize its C-Qur mesh, which could lead to infections in patients with the implant. The agency also mentioned issues with the mesh’s packaging that could ruin the mesh’s Omega-3 fatty acid coating. Atrium designed the mesh with this particular coating to encourage the body to absorb it and prevent adhesions.
In 2013, Atrium recalled four models of its C-Qur mesh products, all of which the FDA designated as Class II recalls. The FDA specified that the C-Qur mesh could stick to the inner-handling sleeve when exposed to high humidity. The recall applied to over 145,000 C-Qur units.
Covidien Parietex Composite Parastomal Mesh Recall
Covidien, a subsidiary of Medtronic, recalled 7,333 units of its Parietex Composite Parastomal Mesh in 2018 following reports of “mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique.” At the time of the recall, Covidien had received ten reports of hernia mesh failure requiring surgical treatment in the last five years. Patients with a failing Covidien mesh experienced discomfort, painful bulging, and changes in the overlying skin.
Hernia Mesh Multidistrict Litigations
There are several ongoing MDLs related to defective hernia mesh implants. It is important to note that while the MDLs have received significant attention, they only represent a portion of the hernia mesh products subject to litigation, with additional state-filed lawsuits covering products not included in the federal MDLs.
The sheer volume of hernia mesh lawsuits filed in the last few years warranted the creation of multiple MDLs against Atrium, Bard, Covidien, and Ethicon.
Atrium C-Qur Mesh MDL
In December 2016, the Judicial Panel on Multidistrict Litigation (JPML) consolidated claims against Atrium, alleging the company’s C-Qur mesh products incite an allergic or inflammatory response that causes severe complications. The panel selected the Honorable Landya B. McCafferty to oversee MDL No. 2753 IN RE: ATRIUM MEDICAL CORP. C-QUR MESH PRODUCTS LIABILITY LITIGATION and transferred the cases to the District of New Hampshire.
As of March 2023, 3,393 actions were pending in MDL No. 2753 against Atrium.
Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh MDL
This is the second MDL launched against Bard for its faulty hernia mesh devices, the first being the company’s Kugel Patch mesh. The Kugel Patch MDL began in 2007 and ran until 2017, when the panel officially ended the MDL after ten years.
The current MDL against Bard concerns its polypropylene hernia mesh products. In August 2018, the JPML centralized polypropylene mesh lawsuits in the Southern District of Ohio and selected the Honorable Edmund A. Sargus as the presiding judge. These lawsuits claim patients implanted with this mesh endured adhesions, organ damage, inflammatory and allergic responses, foreign body rejection, mesh migration, and infections.
As of March 2023, 18,988 actions were pending in MDL No. 2846 IN RE: DAVOL, INC./C.R. BARD, INC., POLYPROPYLENE HERNIA MESH PRODUCTS LIABILITY LITIGATION.
Ethicon Physiomesh Flexible Composite Mesh MDL
In June 2017, the JPML created MDL. No. 2782 IN RE: ETHICON PHYSIOMESH FLEXIBLE
COMPOSITE HERNIA MESH PRODUCTS LIABILITY LITIGATION to house claims that Ethicon distributed a defective mesh that could result in complications once implanted. Plaintiffs argued the mesh could lead to herniation through the mesh, hernia recurrence, and deformation of the mesh. Furthermore, lawsuits noted the multi-layer coating of the Physiomesh prevented adequate incorporation of the mesh inside the body and that its coating could not withstand abdominal forces.
Ethicon challenged the motion to centralize, arguing that the unique facts of each plaintiff’s case would dominate the proceedings and that MDL would only encourage meritless filings against the company. However, the JPML disagreed. The panel transferred the claims to the Northern District of Georgia and placed Judge Richard W. Story in charge of the MDL.
As of March 2023, 1,455 actions were pending in the Ethicon Physiomesh MDL.
Covidien Hernia Mesh MDL
The JPML previously rejected Covidien’s motion to centralize litigation in July 2020, because only 12 cases were pending at that time. However, the panel did consolidate claims against the manufacturer in June 2022, following a renewed motion from Covidien. In the new request, Covidien noted that state court cases had increased significantly and would continue to grow since tolling agreements for 6,000 claims were nearing expiration.
As of March 2023, 362 cases were pending in MDL No. 3029 IN RE: COVIDIEN HERNIA MESH PRODUCTS LIABILITY LITIGATION (NO. II).
Hernia Mesh Lawsuits Status of Litigation
We have gone through three hernia mesh trials against Bard, two of which were bellwether trials and the other a state trial. COVID-19 led to several delays and forced the courts to reschedule several bellwether trials. A third bellwether trial involving Bard was scheduled for May 2023, but the MDL judge granted Bard’s request to postpone the trial. Recently, the judge reset the trial date for October 16, 2023.
There is currently no bellwether schedule for either the Atrium MDL or the Ethicon MDL. Hernia mesh settlements in the Atrium and Ethicon MDLs are reportedly underway, although settlement amounts have not been disclosed to the public.
Hernia Mesh Settlements and Verdicts
The first bellwether trial against Bard began in July 2021 and ended in a defense verdict. Yet, the jury ruled in favor of the plaintiff in the second bellwether trial in April 2022, awarding him $255,000.
In a considerable victory for hernia mesh plaintiffs, a state trial in Rhode Island concluded in a $4.8 million verdict against Bard in August 2022.