Many 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. They also allege that they were not properly warned of the dangers of this proceed mesh medical device. Will there be a Proceed Hernia Repair Surgical Mesh by Ethicon settlement in 2018? Many victims are searching the world wide web for hernia mesh settlements information. Other victims are seeking info about “symptoms of hernia mesh problems.” Despite, numerous recalls and lawsuits, Ethicon Inc. is still currently marketing Proceed hernia mesh. If you need to file a proceed hernia mesh lawsuit then contact a proceed mesh lawsuit law firm.
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
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.
This surgical mesh proceed post looks into the complicated issues related to a mesh recall and addresses an important question many victims are wondering: what is proceed mesh made of? Was a proceed mesh brochure ever circulated? How do I find out if the mesh implanted in me was previously subjected to a proceed ventral patch recall? How do I determine the proceed mesh recall lot number? If the proceed mesh implanted in me was not technically subject to the Ethicon proceed mesh recall, can I still file a Proceed mesh lawsuit? What firm is the best Proceed mesh law firm in the United States?
We are currently reviewing for potential lawsuits, the following types of mesh manufactured by Johnson & Johnson and Ethicon Inc:
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
Proceed Surgical mesh | Ethicon proceed mesh lawsuit
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.” https://www.accessdata.fda.gov/cdrh_docs/pdf6/K060713.pdf
Who is Ethicon and what involvement do they have with Proceed Mesh?
“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 medical devices recalled (Many already surgically implanted)
On January 04, 2006 a FDA product recall of PROCEED Surgical Mesh occurred. Victims are seeking more information about the Ethicon Proceed recall. Most importantly victims were trying to determine the proceed mesh recall lot numbers. This was a disturbing and unsettling recall of 18,270 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.” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=43417&CREATE_DT=2006-01-26
Proceed Mesh recall | 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. Ethicon’s 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
This proceed mesh recall was unfortunate to say the least. 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 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
2nd Proceed recall: Proceed Surgical Mesh recall 2010- Very limited (87 mesh devices) but unsettling
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.
|Date Initiated by Firm|
|Recall Status1||Open3, Classified|
|Recall Event ID||57021|
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 2018” 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 2017. It is time for Ethicon and Johnson and Johnson to open up their pocketbook and make “hernia mesh settlement 2018” 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 email@example.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
- proceed mesh brochure
- symptoms of hernia mesh problems
- proceed mesh price
- proceed mesh recall lot numbers
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.” https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2017-8-17-proceed-caveeck-complaint.pdf
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 studies383‡
- 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” http://www.ethicon.com/healthcare-professionals/products/hernia-repair-and-fixation/hernia-mesh-tissue-separating-mesh/proceed-ventral-patch
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 2018. Johnson and Johnson played hardball concerning mesh settlements 2017. This makes it nearly impossible to determine what the average settlement for proceed mesh 2017 or the average Proceed mesh patch settlements 2018. 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:
Catalog Number PVPS
Device Problem Migration of device or device component
To date the device has not been returned. If the device or further details are received at a later date a
supplemental medwatch will be sent. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
It was reported that the patient underwent an umbilical hernia repair procedure on (b)(6) 2010 and mesh was
implanted. The patient experienced erosion and recurrent hernia. On (b)(6) 2011, the patient underwent removal of encapsulated ventral hernia mesh and scar revision, with midline diastasis plication and placement of strattice xenograph. No additional information was provided.”