Ethicon PROCEED Hernia Mesh Lawsuit | Three FDA Recalls

Many Proceed mesh lawsuits are now pending against Johnson and Johnson and their corporate subsidiary Ethicon, as a result of the allegedly defective PROCEED Ventral Patch. Some surgical mesh attorneys and hernia mesh victims assert that the PROCEED hernia mesh is defective. These hernia mesh attorneys cite multiple recalls of Proceed hernia mesh in 2006, 2010 as well as 2014. They also allege that they were not properly warned of the dangers of the Proceed mesh medical device. Most significantly, Proceed mesh is composed of the synthetic material polyproplene which is widely known to be inherently dangerous to the human body often leading to complications such as sepsis, infection, hernia recurrence, mesh rejection as well as chronic pain.

Will there be a Proceed Hernia Repair Surgical Mesh by Ethicon settlement in 2024? Many victims are searching the world wide web for hernia mesh settlement information. Other victims are seeking info about “symptoms of hernia mesh problems” or “hernia mesh complications and pain years later.” Unbelievably, despite, numerous recalls and lawsuits, Ethicon Inc. is still currently marketing Proceed hernia mesh for surgical hernia repair. If you need to file a proceed hernia mesh lawsuit then contact a proceed mesh lawsuit law firm.

UPDATE- February 1st, 2023 – Case management order #28 -“The Plaintiffs’ Executive Committee (“PEC”) is directed to establish two qualified settlement fund accounts at Deutsche Bank to receive and disburse funds as provided in Case Managements Order No. 9 (“The MCL CB Fund Accounts”). The first fund shall be designated the “MCL No. 630 Fee Fund” and the second fund shall be designated the “MCL No. 630 ExpenseFund. These funds will be held subject to the direction of this Court.”

8/22/23- Judge Porto issued Case management order #26. This order states that the first trial would occur in February 2023.

1-13-22-  Judge John C. Porto of the SUPERIOR COURT OF NEW JERSEY LAW DIVISION: ATLANTIC COUNTY issued case management order number 22 which states in pertinent part: “If any case selected for trial is dismissed on or before January 31, 2022, the case shall be replaced with a case selected in the same manner as the dismissed case pursuant to the Fourth Amended Case Management Order No. 7;2. If any case selected for trial is dismissed voluntarily by plaintiffs between January 31, 2022 and March 1, 2022, the defendants will select the replacement case from the Discovery Pool and the parties will work diligently to complete discovery in the replacement case. 3. If any case selected for trial is settled or otherwise requested by defendants to be eliminated from the Trial Pool between January 31, 2022 and March 1, 2022, the plaintiffs will select the replacement case from the Discovery Pool and the parties will work diligently to complete discovery in the replacement case.” 

1/13/22– The Court “ORDERED that the Therron Hughes case is removed as a trial section of The Court and is replaced by Donald Denton, ATL-L-442-20″

• The Ethicon Proceed Hernia Mesh Multi-County Litigation is currently pending in the Superior Court of New Jersey Law Division- Atlantic County- MCL Case No: 630.
• The caption of the case is: IN RE PROCEED MESH LITIGATION.
• On August 20th, 2019 the Court issued CASE MANAGEMENT ORDER 3
• On April  15, 2020 Justice Porto issued his 11th Case management Order, “that the date for selection of the cases for individual discovery is extended from April 15, 2020  until April 17, 2020.”
• On November 19th, 2021 the Court issued Case management order #22 which in pertinent part states,”Should the Plaintiff(s) fail to cure the deficiencies within 30 days of the date of the emailed notice, the Defendant(s) shall be permitted to file a motion to dismiss Plaintiff(s)’ Complaint without prejudice without further leave of Court.”
• Proceed hernia mesh was recalled in 2006, 2010 and 2014 but is currently on the market, nonetheless.

Get all the case management orders here.

Ethicon laughably asserts that the Proceed Ventral patch and Proceed hernia mesh, “has demonstrated a recurrence rate of just 0% to 10% in multiple studies.” Ethicon also asserts on its website that Proceed mesh has, “Strong repair with potential for low recurrence.”‘ Ethicon website

 Proceed mesh state court consolidated lawsuit

• On March 12, 2019 the Supreme Court of new Jersey, “Ordered that all pending and future New Jersey state court actions against Ethicon Inc. and Johnson and Johnson, alleging injuries as a result of use of Proceed Surgical Mesh and Proceed Ventral Patch hernia mesh products be designated as multicounty litigation (“MCL”) for  centralized management purposes…”
• On May 1, 2019 Glenn A. Grant, J.A.D., Acting Administrative Director of the Courts issued a notice to the bar entitled “NOTICE TO THE BAR MULTICOUNTY LITIGATION – PROCEED® SURGICAL MESH AND PROCEED® VENTRAL PATCH LITIGATION” Proceed notice
• This notice stated:  “A previous Notice to the Bar requested comments on an application for multicounty litigation (MCL) designation of New Jersey state-court litigation alleging injuries resulting from use of certain hernia mesh products. This Notice is to advise that the Supreme Court, after considering the application and the commentsreceived, has determined to designate only the cases involving allegations of injuries from use of Proceed® Surgical Mesh and Proceed® Ventral Patch as multicounty litigation. The Court determined not to designate litigation involving the Prolene® Hernia Mesh System as multicounty litigation. The Court has assigned the Proceed® MCL to Atlantic County for centralized case management by Superior Court Judge John C. Porto. Published with this Notice is the Supreme Court’s March 12, 2019 Order. This Order is posted in the Multicounty Litigation Center http://www.njcourts.gov/attorneys/mcl/index.html on the Judiciary’s website (www.njcourts.gov). Judge Porto’s Initial Case Management Order will be posted in the Multicounty Litigation Center. Questions concerning this matter may be directed to Melissa A. Czartoryski, Chief, Civil Practice Division, Administrative Office of the Courts, Hughes Justice Complex, P. 0. Box 981, Trenton, New Jersey 08625-0981; telephone: (609) 815-2900 · ext. 54901; e-mail address: Melissa.Czartoryski@njcourts.gov. Proceed notice

Many victims are confused about hernia mesh lawsuits in general and some hernia mesh victims incorrectly spell proceed mesh as “proced” mesh. After some cursory investigation, these victims no longer call the mesh “proced mesh.”

Mesh fact sheet

“Made to patch hernias that rupture the abdominal wall, the Proceed hernia mesh was constructed out of a lightweight polypropylene mesh called Prolene. This soft mesh was then coated with oxidized regenerated cellulose (ORC) to prevent injury within the body. Unfortunately, the entire device was radiated to make the coating resorbable—unknowingly starting a degradation process to the mesh polymer beneath, which caused product shrinkage, disintegration and migration throughout the body.” Mesh Fact Sheet

Proceed mesh

Despite these assertions by Ethicon, many victims have filed proceed mesh lawsuits. If you are looking for a mesh firm to file a Proceed hernia mesh lawsuit, retain one of the best  Proceed mesh law firms. Ethicon and Johnson and Johnson have equally disturbing and embarrassing issues related to another allegedly defective hernia mesh medical device they manufacture, Ethicon Physiomesh.

What is Proceed?

We are reviewing for lawsuits, the following types of mesh manufactured by Johnson & Johnson

• Physiomesh
• Prolene Hernia System (PHS)
• Prolene 3D Patch
• Ultrapro
• Proceed hernia mesh

Proceed hernia mesh  otherwise known as Proceed mesh has a reputation for causing infection and pain as well as bowel obstruction. There have been reported instances of the device disintegrating after implanted in the victims body. “Based on FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation).” FDA

 Ethicon proceed mesh lawsuit FDA approval

Proceed hernia mesh settlement 2020

Proceed Surgical Mesh was approved by the FDA on 05/25/2006 as a result of the FDA’s controversial 510(k) premarket notification process. The FDA 510k process does not require clinical human trials before a medical device can be marketed by the manufacturer. Johnson and Johnson asserted that Proceed Surgical mesh was substantially similar to a predicate device: PROCEED Trilaminate Surgical Mesh. Johnson and Johnson asserted that “PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.” FDA  

Who is Ethicon and what involvement do they have with Proceed?

“Defendant Ethicon, Inc. is a wholly owned subsidiary of Defendant Johnson & Johnson. Defendant Ethicon, Inc. is a corporation incorporated in the State of New Jersey with its principal place of business in Somerville, New Jersey. Ethicon is a medical device company involved in the research, development, testing, manufacture, production, marketing, promotion and/or sale of medical devices including Proceed (hereinafter may be referred to as the “product”).  J&J, directly and/or through the actions of Ethicon, Inc., has at all pertinent times been responsible for the research, development, testing, manufacture, production,marketing, promotion, distribution and/or sale of Proceed.”  RUBY CAVEECK complaint against Ethicon, IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF PENNSYLVANIA, Case 2:17-cv-01084-JFC Document 1 Filed 08/17/17

Proceed Surgical Mesh recall 2006- 18,270 devices recalled

• On January 04, 2006 a FDA product recall of PROCEED Surgical Mesh occurred.
•  This was a disturbing and unsettling recall of 18,270  Proceed hernia mesh medical devices!
• Many of these defective Proceed medical devices had already been implanted in unwitting victims.
• According to the FDA, “There is a total of 1,070 consignees that have received recall product divided between hospitals and distributors nationwide. The product has been distributed internationally to the following countries: Argentina, Australia, Austra, Brazil, Canada, Chile Colombia, Czechoslovakian Republic, France, Germany Greece, Guaynabo, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Republic of Yemen, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirate, United Kingdom, Venezuela.”  FDA 
• Ethicon’s  stated reason for the Proceed mesh recall was “Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.” FDA recall report

Victims are seeking more information about the Ethicon Proceed recall. Most importantly victims are trying to determine the proceed mesh recall lot numbers.

Ethicon proceed mesh recall

The FDA listed the Recalling Firm / Manufacturer as, “Ethicon, Inc. US Highway 22 West Somerville NJ 08876.” It is widely known that Ethicon’s corporate headquarters are in New Jersey to this day.  This proceed mesh recall was unfortunate to say the least. Any surgical recall is troubling on many levels. An Ethicon proceed recall is the last thing Johnson and Johnson needed at that time. This hernia mesh recall may have been the impetus for some people to file a proceed mesh lawsuit.

This  surgical recall was Terminated ³ on September 28, 2006.  For information on recalls in general, see also:

• Voluntary Recalls – 21 CFR 7
• Mandatory Device Recalls – 21 CFR 810
• Corrections and Removals – 21 CFR 806
• Definitions 
• Overview

• On October 18, 2010 the FDA issued a class 2 medical device recall of PROCEED Surgical Mesh.
• To be fair to Ethicon, the class 2 recall was not for all proceed hernia mesh but pertained to: PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618.
• There were only  87 medical device products recalled by Johnson and Johnson.
• Date Initiated by Firm: October 18, 2010, Date posted: January 14, 2011. Recall number:  Z-0903-2011 FDA Recall event ID: 57021.
• According to ‘spin’ from Ethicon the reason for the recall was “There is a potential for delamination in one lot of Proceed surgical mesh.”
• The FDA Determined Cause for the Proceed mesh recall was “Nonconforming Material/Component.”

Ethicon took the following action as a result of the recall, “Ethicon sent Urgent Voluntary Product Recall letters via Fed Ex on October 18, 2010. The letters described the issue with the affected product and instructed customers not to use it. They are to immediately remove the recalled product from their inventory and return it according to the instructions provided. A reply card is attached and must be filled out and returned to Stericycle whether or not the customer has product in their possession. Separate correspondence has been sent to end customers stating that if they have purchased the recalled product through a distributor, to return the product directly to Stericycle. Replacement product will be provided at no additional charge for all recalled product.” Id. 

Despite the fact that the number of recalled Proceed mesh medical devices were a limited amount, the recall is disturbing nonetheless. Such defects in medical devices can cause serious complication, injuries and symptoms on unwitting victims. Such alleged pattern of negligence  and carelessness from Ethicon could be used as leverage by top Plaintiff hernia mesh law firms to make a “Proceed hernia mesh settlement 2020” a reality rather than a pipe dream.

Proceed mesh victims are desperately seek a surgical mesh settlement and are disappointed there was no global hernia mesh settlement 2019. It is time for Ethicon and Johnson and Johnson to open up their pocketbook and make “hernia mesh settlement 2020” a reality.  The purpose of this post and other posts on this blog concerning Ethicon Physiomesh is to provide a Johnson and Johnson Mesh lawsuit update.

3rd Ethicon Proceed recall: Proceed hernia mesh recall 2014

• On February 19, 2014 the FDA issued a “Class 2 Device Recall Ethicon Inc.” 
•  The class 2 recall pertained to: Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. (Product Code PCDB1 – Lot number – GGG157, Product Code PCDT1 – Lot number – GGG158, Product Code PCDJ1 – Lot number -GGG159)
• The Manufacturer Reason for Recall: “The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination”. Id.

Ethicon took the following action as a result of the Proceed mesh recall, “Ethicon sent an Urgent Medical Device Recall letter dated February 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to examine their inventory and determine if they have any of the affected product. If any product has been distributed, those hospitals should be notified. The business reply form should be completed and faxed or emailed to Stericycle at 1-888-641-9732 or ethicon5798@stericycle.com. For clinical or product support contact a customer representative or call the Customer Support Center at 1-877-ETHICON to speak with a registered nurse or contact Stericycle at 1-888-345-0524 and reference event #5798. Stericycle is handling returns.”  FDA

This is another troubling Proceed mesh misstep by Johnson and Johnson and their corporate subsidiary Ethicon Inc. All of these missteps can only lead to one conclusion, Ethicon must open up their pocketbooks for a global Proceed mesh settlement 2018.

Assorted Proceed hernia mesh lawsuits

Below you will find some descriptions and allegations of various hernia mesh lawsuits against Ethicon as a result of Surgical Proceed mesh.

SHELLY K. COPPEDGE v. Ethicon

• In 2012 SHELLY K. COPPEDGE filed a lawsuit against ETHICON, INC.
• This lawsuit was filed on August 2nd, 2012 IN THE UNITED STATES DISTRICT COURT EASTERN DISTRICT OF TEXAS MARSHALL DIVISION.
• Ms Coppedge requested a jury trial seeking her day in Court as a result of the complications she suffered as a result of Proceed hernia mesh.
• She alleged that “The surgeon herein used Proceed Oval Mesh, manufactured, designed, and marketed by Ethicon, Inc., with Lot No. BHG341, and Catalog No. PCDG1.”
• Aboutlawsuits reported on the Coppedge lawsuit stating,”A lawsuit has been filed over problems with Ethicon Proceed hernia mesh, alleging that the patch disintegrated inside the body of a Texas woman, leading to infection and other complications.” https://www.aboutlawsuits.com/ethicon-proceed-hernia-mesh-lawsuit-31609/

According to the complaint, “Plaintiff Shelly K. Coppedge required subsequent surgeries to try to remedy the complications cause by the mesh, including a disintegration of the mesh and infection of the mesh. Even after the two subsequent surgeries, Plaintiff Shelly K. Coppedge continues to suffer various infirmaries due to complications caused by the Proceed mesh that was designed, marketed, and tested by Defendant Ethicon, Inc.” https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2012-08-02-Ethicon-Proceed-Complaint.pdf

Ms. Coppedge acting by and through her hernia mesh attorneys and their hernia mesh law firm further went on to allege, “The Proceed Mesh was defective and unreasonably dangerous, and not suitable for implantation in Shelly K. Coppedge, and others similarly situated. The product was not properly tested and was marketed as being reasonably safe for its intended use as an implantable mesh for incisional hernias, among other ailments. This defective product was a producing cause of Plaintiff Shelly K. Coppedge’s injuries and damages.” Id.

“Defendant made implied and express warranties to Shelly K. Coppedge, and others similarly situated in the stream of commerce, that the product (Proceed Mesh) was safe, had been tested, and was a better alternative for its intended use as an implantable mesh to treat an incisional hernia than other products. This was not true at the time of the implantation in August of 2009 for which Plaintiff was not warned or instructed, nor were any of the medical professionals in the stream of commerce notified of the problems to which Ethicon, Inc. was fully aware of by August of 2009.” Id.

What is proceed mesh made of?

“Proceed Hernia Repair Surgical Mesh by Ethicon PROCEED™ Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is composed of an oxidized regenerated cellulose (ORC) fabric, and PROCEED™ Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth, while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer.” Medline

Another Proceed mesh lawsuit

• In a lawsuit complaint filed in IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF PENNSYLVANIA, the victim asserted that “Defendants’ Proceed was defectively designed and/or manufactured, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design. As a result of the defective design and/or manufacture of the Proceed, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including: chronic pain; recurrence of hernia; foreign body response; rejection; infection; inadequate or failure of incorporation/ingrowth; migration; scarification; deformation of mesh; improper wound healing; excessive and chronic inflammation; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tissue damage and/or death; and other complications.” Caveeck Complaint 

A discovery stipulation concerning Proceed Mesh

Read a discovery/ document production stipulation entered into by Johnson and Johnson and the hernia mesh law firms “Plaintiffs and Defendants Ethicon, Inc. (“Ethicon”) and Johnson & Johnson (“J&J”) (collectively, “Defendants”) have advised the court that they desire to enter into a stipulation concerning the production of hernia mesh documents for the Prolene, Prolene Soft, Ultrapro, Proceed and Vypro hernia mesh products.”  https://www.wvsd.uscourts.gov/MDL/ethicon/pdfs/PTO_66.pdf

Ethicon asserts the following propaganda:

• “A study of PROCEED Mesh demonstrated a low recurrence rate (1.3%) at 1 year³⁸²
• Mesh repairs demonstrated superior to suture repair in multiple open hernia studies^383‡
• Mesh repair has demonstrated a recurrence rate of just 0% to 10% in multiple studies³⁸³
• Conventional suture repair has a recurrence rate of up to 63%³⁸³
• Partially absorbable design is engineered to minimize adhesions³⁸¹
• Unique construction of PDS® support ring helps ensure compliance with abdominal wall³⁸¹
• Distributes abdominal forces equally across the mesh³⁸¹
• Does not buckle when pulled up toward the abdominal wall³⁸¹
• Secure placement and stable positioning” Ethicon 

Proceed mesh Adverse event reports:

It is troubling that there are a number of FDA adverse event reports related to Proceed hernia mesh. Victims can only hope that the combination of FDA adverse event reports combined with a growing number of proceed Ventral Patch mesh lawsuits will convince Ethicon and Johnson and Johnson to engage in Proceed ventral patch mesh settlements 2020. Johnson and Johnson played hardball concerning mesh settlements 2020. This makes it nearly impossible to determine what the average settlement for proceed mesh 2020 or the average Proceed mesh patch settlements 2020. Many surgical mesh victims are concerned with complications years later that they may not be able to anticipate at this time.

Below I have set forth various  FDA adverse event report related to Proceed hernia mesh: