Below you will find a timeline of important dates and events concerning Hernia Mesh manufactured by Bard / Davol. This hernia mesh lawsuit timeline is very complicated and convoluted, to say the least. This post was authored by a hernia mesh lawyer. Thousands of mesh victims filed lawsuits against Bard and their corporate subsidiary Davol seeking compensation by way of settlements or legal judgment as a result of purported defective hernia mesh and hernia patches. These victims are seeking settlements or legal judgments from Bard Davol as a result of the alleged defective surgical mesh. Bard’s hernia mesh medical devices have been subject to numerous mesh recalls. Will there be a hernia mesh recall in 2018? Will there be a Bard Davol hernia mesh lawsuit settlement 2018? No one can accurately predict whether such a hernia mesh settlement will occur.

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Bard Davol hernia MESH LAWSUIT

1996- Surgical Sense Inc. submits FDA application for “Kugel™ Hernia Patch”

On August 5th, 1996 Surgical Sense Inc. from Arlington Texas submitted a 510(k) application pursuant to 21 CFR 807.9  for the “Kugel™ Hernia Patch.” Surgical Sense Inc. classified this medical device as “surgical mesh.” Surgical Sense Inc. alleged that the “Kugel Hernia Patch” was substantially equivalent to: “Atrium Polypropylene mesh.”They asserted to the FDA that the “intended use of the Kugel hernia Patch is a surgical mesh for reinforcement of a hernia defect” Federal Drug Administration (FDA), Kugel Hernia Patch 510 (k) summary

1997- Davol introduces “Composix™ hernia patch

“In 1997, Davol released the Composix™ hernia patch, a forerunner to the CK Patch.The Composix patch is composed of two layers of

bard-davol-hernia-mesh-lawsuit

Hernia mesh settlement 2017

polypropylene mesh for tissue ingrowth on the abdominal side, and a layer of ePTFE on the other side to prevent bowel adhesion to the mesh. The Composix patch does not contain a ring. Prior to placing the Composix patch on the market, Davol conducted animal testing by implanting the patch into the abdominal cavity of pigs. Davol submitted the testing results in a so-called 510(k) application to the Food and Drug Administration (“FDA”) in order to get clearance to market the Composix patch.” CHRISTOPHER THORPE and LAURE THORPE, Plaintiffs v.  DAVOL, INC. and C.R. BARD, INC., Defendants. C.A. No. 008-463ML MDL Docket No. 07-1842ML In Re: Kugel Mesh Hernia Repair Patch Litigation  https://www.lawyersandsettlements.com/articles/kugel-mesh/interview-kugel-mesh-lawsuit-patch-20010.htm

 

Premarket Notification

Bard Davol is a frequent flier using and abusing the shady and controversial FDA 510(k) Premarket Notification process. Over and over again, Bard Davol utilized mesh with an extensive, known history of victim complications as a predicate device to get allegedly defective hernia mesh to the market without proper clinical trials. It is apparent that the FDA 510(k) application process is the root of the problem for defective hernia mesh. The FDA 510(k) application is a controversial process which allows medical device manufacturers to fast track medical devices while evading FDA testing protocol. see also: SAY IT AIN’T SO! : FDA ALLOWS RELEASE OF DEFECTIVE HERNIA MESH 

2000- Davol aquires the Kugel™ hernia patch from Surgical Sense Inc.

Hernia Mesh Surgery complications

Bard Davol hernia mesh settlement 2018

“Davol acquired the Kugel™ hernia patch from Surgical Sense Inc., which marketed the Kugel™ patch for several years.”  Id. “Eventually, the CK Patch was designed with two layers of polypropylene mesh, a layer of ePTFE, and a PET memory recoil ring welded between the layers of polypropylene mesh. The XL CK Patch featured larger sizes, two PET rings, and placement pockets for easier deployment of the patch.”  Id. “Because Davol considered the XL CK Patch products a modification to an existing product (the one-ringed CK Patch in small and medium sizes), it made an internal determination that a 510(k) submission to the FDA was not warranted.” http://lawyersusaonline.com/wp-files/pdfs-3/thorpe-v-davol.pdf

On 03/02/2000 the FDA gave clearance to Genzyme to market SEPRAMESH pursuant to the controversial 510(k) premarket approval process. The 510k summary was required pursuant to 21 CFR 807.92 Read the  510(k) summary here. Genzyme asserted that Sepramesh was substantially similar to other hernia mesh that was on the market at that time: Bard Mesh, Bard Composix Mesh and Mersilene Mesh manufactured by Ethicon.  (In 2007 Bard essentially became the owner of Sepramesh.)

August 25, 2000:  Davol /Bard submitted an application to the FDA for  the Composix E/X Mesh Patch. “On August 25, 2000, Davol / Bard submitted an application to the Federal Drug Administration to notify of its intent to market the Composix E/X Mesh Patch for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Thereafter, the 510k Application was approved by the FDA and the Composix E/X Mesh Patch was classified as a Class II medical device.” Id.  Beasley Allen 

“The Composix E/X Mesh Patch was designed, manufactured, sold and distributed by DAVOL to be used by surgeons for hernia repair surgeries and was represented by DAVOL to be an appropriate, cost-effective and suitable product for such purpose.” http://www.beasleyallen.com/news/federal-court-expands-scope-of-kugel-mesh-hernia-patch/

2002- Here comes the XL CK Patch and Ventralex Patch

In 2002 the XL CK  Patch medical device was sold for the first time Id. In 2002, medical doctors began reporting problems with the Composix Kugel Mesh Patch. “a growing number of physicians began to report major abdominal injuries in their patients which stemmed from broken memory recoil rings in the patches.” Legal tube

On July 16th 2002, the FDA  approved the premarket notification submitted by Davol for the Ventralex Patch.  Bard got the Ventralex Patch approved by using the Bard Composix Kugel Mesh as the predicate device.  Davol asserted that the Ventralex patch was substantially similar to the Bard Composix Kugel Mesh. In 2006 Bard recalled the Kugel Mesh.   Davol asserted that “The Ventralex Patch is intended for use in all hernia repairs requiring reinforcement with a nonabsorbable support material.”

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hernia MESH LAWSUIT

2003- problems emerge with CK Patch

In the 2003 time period, “Davol first learned of a ring break in its CK Patch product line in 2003.” “In October 2003, Davol decided to enhance the weld strength of the memory recoil rings in all its CK patch products.” Id.

2005-  XL CK patch recalled by Davol – hernia mesh recall

“By mid to late 2005, Davol became aware of an increase in reported ring breaks in the XL CK Patch. Davol initiated a Corrective and Preventive Action (“CAPA”) investigation into the complaints. Davol also communicated the complaints to the FDA, informing it that the exact cause of the ring breaks was undetermined and that a recall did not appear warranted at that time.” Id.

“On August 31, 2005, production of XL CK Patches was halted while Davol investigated ring break complaints. Distribution of the XL CK Patches was discontinued on December 8, 2005.” Id.

“In a December 21, 2005 letter from Karen Kane (“Kane”) Manager of Davol’s marketing department, the sales force was advised that XL sizes of the CK Patch were being recalled because “the strength of the memory recoil ring may not withstand aggressive manipulation that may sometimes be applied during the placement of these extra-large sizes.. Kane further stated that customers asking for XL sizes of the CK Patch should be advised that the XL CK Patches were “currently not available and that Customer Service is offering the equivalent sizes of the Composix EX as an alternative.” Id.

December 22, 2005:  Class 1 Device Recall Bard  Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7” x 10.7”  Code: 0010206

December 27, 2005: C.R. Bard notifies US customers of a voluntary Class I recall of the Bard Composix Kugel Mesh X-Large Patch by letter delivered via Federal Express. The recall is issued after reports that a component of the patch, known as the memory recoil ring, may not withstand certain stresses associated with specific surgical placement techniques. Breakage of the memory recoil ring can cause bowel perforations and chronic intestinal fistulae. At the time, approximately 32,000 units had been sold worldwide.’  Lawyers and settlements

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Bard Composix Mesh

“On December 28, 2005, Davol issued an “Urgent Product Recall” for the XL CK Patch to “Distributor: (Hospital Administrator, Materials Manager, O.R. Manager, Surgeon).” Pltfs.’ Ex. 676. Davol informed its customers that it was voluntarily recalling three product codes of the XL CK Patch because it had “received complaint reports of the PET recoil ring breaking which could potentially lead to bowel perforation and/or chronic enteric fistulas. We have identified a rate increase of recoil ring breaks since the introduction of these product codes in 2002. We estimatethe frequency of these reported events to be in the range of 0.08%. ” http://lawyersusaonline.com/wp-files/pdfs-3/thorpe-v-davol.pdf

2006- XL CK Patch recall is expanded- hernia mesh recall

The expanded class 1 FDA recall on Febuary 22nd  2006 included “certain lots of the Large Oval and Large Circle products, as well as all lots of the Oval product” Id. The recalling firm was: “Davol, Inc., Sub. C. R. Bard, Inc.” Here is a list of the recalled products:

  1.  Bard Composix Kugel Mesh X-Large Patch Oval With EPTFE, 8.7” X 10.7” Code: 0010206
  2. Bard Composix Kugel Mesh X-Large Patch Oval With EPTFE, 8.7” X 10.7” Code: 0010206
  3. Z-0762-06 – Bard® Composix® Kugel Oval, 6.3” X 12.3” For Hernia Repairs Product Code: 0010209
  4. Z-0760-06 – Bard® Composix® Kugel Large Oval, 5.4” X 7” For Hernia Repairs Product Code: 0010202
  5.  Z-0761-06 – Bard® Composix® Kugel Large Circle, 4.5” For Hernia Repairs Product Code: 0010204
  6. Z-0526-06 – Bard Composix Kugel Mesh X-Large Patch Oval With EPTFE, 7.7” X 9.7” (19.6cm X 24.6cm) Code: 0010208

(“Recalled for potential for ring to break leading to bowel perforation and/or chronic enteric fistula.”) Drug Watch

March 24, 2006: An urgent letter is sent by Bard to hospital administrators advising them that the Class I recall has been expanded to include certain lots of the Large Oval and Large Circle products, as well as all lots of the Oval product. A letter sent to distributors of the Kugel Mesh Patch states that the recall includes lots manufactured up to and including December, 2003, and notes that “there is a risk that the welds could break under the stress placed on the large sized products during placement, which could lead to potential patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas….Finally, a letter is sent to surgeons the same day requesting that they immediately stop using the specific products listed in the recall and give copies of the Important Patient Management Information to professionals who are managing patients already implanted with the recalled products. The expanded recall is issued because Davol, Inc., has learned of further ring breaks, including cases of bowel perforation, ring migration through the abdominal wall, bowel obstruction, and one instance in which a patient died after developing septic shock, consumptive coagulopathy and acute myocardial infarction from surgery to repair bowel fistulas caused by perforation from the broken ring.2005” https://www.lawyersandsettlements.com/articles/drugs-medical/kugel-mesh-timeline-00568.html

April 3, 2006: ” The US Food and Drug Administration (FDA) and Davol, Inc (a subsidiary of C.R. Bard, Inc), have notified healthcare professionals regarding the expansion of a class 1 recall for a ventral hernia repair device ( Bard Composix Kugel Mesh Patch) to include all lots of the oval “midline” size (product code 0010209), and lots manufactured before 2004 of the large oval (0010202) and large circle (0010204) products. The recall previously affected only the extra-large oval patch.”

“The recall is due to the potential for breakage of the “memory recoil ring” under the stress of placement into the intraabdominal space, leading to bowel perforation and/or chronic enteric fistulae, according to an alert sent yesterday from MedWatch, the FDA’s safety information and adverse event reporting program. ” http://www.medscape.com/viewarticle/529032

On June 2nd, 2006 the FDA issued a decision approving BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH pursuant to the FDA 510(k) Process. The FDA determined that the BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH  was substantially similar to the following predicate devices:

On October 23rd, 2006 the FDA issued a decision approving Bard / Davol’s premarket notification for BARD COMPOSITE L/P MESH pursuant to the FDA 510(k) Process. The FDA determined that BARD COMPOSITE L/P MESH  was Substantially Equivalent (SESE) to the following predicate devices:

  • Bard Large Pore SoftTmMesh Pre-Shaped, K052155 (Davol Inc,), FDA cleared on 10/20/2005;
  • Bard Composix® EIX Mesh, K002684 (Davol Inc.), FDA cleared on 10/1 1/2000;
  • Davol Delivery System (currently marketed as Precision Pass Laparoscopic Delivery Device), K041641 (Davol Inc.), FDA cleared on 07/01/2004.

December 18, 2006: A lawsuit is filed against Davol, Inc. related to the Kugel Mesh Patch. The plaintiff in the case, filed in Rhode Island, claims failure of the Kugel Mesh Patch resulted in severe pain and required bowel dissection surgery to remove the Patch, which had become stuck to the plaintiff’s bowel. The bowel dissection surgery resulted in chronically inflamed bowels. Lawyers for the plaintiff argue that Davol, Inc., knew that there was a possibility of failure in the Kugel Mesh Patch but did not properly warn the public.” Lawyers and settlements

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hernia MESH LAWSUIT

2007- Davol recalls  Bard®Composix® Kugel® Large Sized Patch and Bard® Composix® Kugel® Large Oval and Bard® Composix® Kugel®Large Circle

January 10, 2007: Davol extends the recall to include Large Sized Composix Kugel Patches (oval and circle) due to additional reports of memory recoil ring breakage. Another product with the same component design is also recalled because of the potential for breakage.” https://www.lawyersandsettlements.com/articles/drugs-medical/kugel-mesh-timeline-00568.html

January 10, 2007 the following  medical devices were recalled:

  • Bard Composix Kugel Hernia Patch Large Oval with EPTFE, 5.4” x 7”
  • Bard Composix Kugel Hernia Patch Large Circle with EPTFE, 4.5”

(recalled as a result of ring breakage causing Bowel Perforation and “chronic enteric fistula.” https://www.drugwatch.com/hernia-mesh/)

Bard/ Davol stated ” Davol is expanding the voluntary recall of specific lots of Bard ® Composix ® Kugel ® Large Oval and Large Circle Patches. Immediately discontinue use of the specific product codes and lot numbers listed in the attachment. Additionally, please immediately distribute copies of the Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already implanted with one of these products under voluntary recall.”  HERNIA REPAIR IMPORTANT PATIENT MANAGEMENT INFORMATION: Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal Product Code: 0010202, Bard® Composix® Kugel® Large Oval, 5.4”x7.0” Product Code: 0010204, Bard® Composix® Kugel® Large Circle, 4.5   https://www.davol.com/clinical-support/product-recall-information.

June 22, 2007: The Judicial Panel on Multi District Litigation (JPML) issued a transfer order “for combined cases which involved allegations of defects in various models of hernia patches manufactured and sold by Bard, Davol or Surgical Sense.” Risley v Davol and Bard, Davol In re Kugel Hernia Repair Patch Litigation, MDL Docket No. 07-1842-ML.

On December 17, 2007 C.R. Bard essentially purchased Sepramesh. “MURRAY HILL, N.J., Dec 17, 2007 (BUSINESS WIRE) — C. R. Bard, Inc. (NYSE: BCR) today announced that it has entered into a license agreement with Genzyme Corporation (Nasdaq: GENZ), headquartered in Cambridge, Massachusetts, to manufacture and market the Sepramesh® IP hernia repair product line and to incorporate the related Sepra® coating technology into the development of future hernia repair applications. Bard’s Davol subsidiary, located in Cranston, Rhode Island, will begin marketing the line immediately. Details of the agreement were not disclosed.” CR Bard press release

2008- Federal Judge Expands consolidated lawsuits | hernia mesh lawsuit

“On January 8, 2008, a Federal Court judge in Rhode Island expanded the scope of the consolidated proceedings involving hernia patches manufactured by Davol / Bard to cover all Davol Marlex / Teflon products, with or without “memory recoil rings.” http://www.beasleyallen.com/news/federal-court-expands-scope-of-kugel-mesh-hernia-patch/

On October 07, 2008 the FDA determined that BARD 3DMAX MESH is substantially similar to:

  • Bard Mesh (Davol Inc.)
  • Bard 3DMAX Mesh (Davol Inc.)
  • Usher’s Marlex Tubular Mesh (Davol Inc.)

As a result of that determination, the FDA approved Bard / Davols’ 510(k) premarket notification for BARD 3DMAX MESH and the medical device was allowed to be marketed to the public.

On December 08, 2008 C.R. Bard initiated a class 3 recall of its surgical mesh:

  • Bard 3D Max Mesh, Left large, Sterile Pre-formed Knitted Polypropylene Product Code: 0151531

The FDA listed the manufacturer reason for recall as “Mislabeled: Product labeled as Left large, may contain a Right Large.” The FDA described the reason for the recall of this Bard 3Dmax mesh was “Mixed-up of materials/components”

According to the FDA,  Davol took the following actions: “Davol issued a letter notification dated 12/25/08 via Federal Express requesting accounts discontinue use, remove product from inventory and return product. For additional information, contact Davol at 1-401-463-7000.” Recall No. Z-0935-2009

2009- BARD PERFIX LIGHT PLUG

On December 8, 2009 the FDA determined that BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 011716  is Substantially Equivalent (SESE) to the predicate devices of:

  • Bard® Soft Mesh (Davol Inc.)
  • Bard® Mesh Dart (Davol Inc.)
  • Bard® PERFIXTM Plug (Davol Inc.)
  • Mersilene Mesh (Ethicon, Irnc.)

The FDA approved Bard / Davol’s 510(k)  FDA premarket notification and approved BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 011716  to be marketed to the general public. The device description in the 510(k) summary for  BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 011716 was “The Proposed Product, Bard® PERFIXT Light Plug is a pre-formed three-dimensional (cone shape) device constructed of a fluted outer layer and multiple inner layers of mesh attached at the tip.” 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Read more here: 3DMAX HERNIA MESH LAWSUITS: SAY IT AIN’T SO FDA!

2010- Bard wins first bellwether hernia mesh trial, victim wins 2nd bellwether trial

1st Bellwether Trial:  In Kugel Patch MDL Ends In Defense Verdict:  Hernia mesh attorneys lose first hernia mesh trial. “PROVIDENCE, R.I. — (Mealey’s) The first bellwether trial involving the Kugel surgical mesh patch ended in a defense verdict on April 14 when a Rhode Island federal jury found that the plaintiff had not proven that his injuries were directly caused by or contributed to by negligent design of the device (In Re:  Kugel Mesh Hernia Patch Litigation, MDL Docket No. 1842, No. 07-1842; John Whitfield v. Davol, Inc., et al., No. 07-1918, D. R.I.). A nine-member jury in the U.S. District Court for the District of Rhode Island, where the Kugel mesh hernia patch multidistrict litigation is centralized, found that plaintiff John Whitfield did not prove that the CK (Composix Kugel) patch was defectively designed or inadequately labeled or that defendants C.R. Bard Inc. and subsidiary Davol Inc. were negligent in labeling the device. Lexis Nexis  

 

2nd Bellweather trial:  Hernia mesh attorneys win 1.5 million verdict! “PROVIDENCE, R.I. – (Mealey’s) The second Kugel surgical patch bellwether trial went to the plaintiff Aug. 23 when a Rhode Island federal court jury awarded $1.5 million to a man who claims that the device caused him internal injuries (In Re:  Kugel Mesh Hernia Patch Litigation, MDL Docket No. 1842, No. 07-1842, Christopher Thorpe v. C.R. Bard, Inc., et al., No. 08-463, D. R.I.).” Plaintiff Awarded $1.5 Million In Second Bellwether Trial In Kugel Hernia Patch MDLA jury in the U.S. District Court for the District of Rhode Island, where the Kugel multidistrict litigation is centralized, found that manufacturing defendants Davol Inc. and C.R. Bard Inc. inadequately designed the Kugel patch and failed to warn plaintiff Christopher Thorpe or his doctor that the device could fail.  The jury awarded Thorpe $1.3 million and his wife, Laure Thorpe, $200,000 for loss of consortium. ” https://www.aboutlawsuits.com/settlements-kugel-hernia-mesh-problems-19474/  https://www.lexisnexis.com/legalnewsroom/litigation/b/litigation-blog/archive/2010/08/23/plaintiff-awarded-1-5-million-in-second-bellwether-trial-in-kugel-hernia-patch-mdl.aspx?Redirected=true

According to law 360, “A jury has awarded $1.5 million to a North Carolina couple injured by allegedly defective hernia patches, but won’t get the chance to impose punitive damages, according to a federal judge overseeing multidistrict litigation against C.R. Bard Inc. and a subsidiary.  Christopher Thorpe won $1.3 million Monday in the second of four bellwether trials in the U.S. District Court for the District of Rhode Island, with wife Laure Thorpe taking home $200,000 for loss of consortium. The couple had claimed that Bard’s Composix Kugel surgical mesh patches were unreasonably designed and carried inadequate warning of risk.  Judge Mary M. Lisi, however, ruled in a minute entry Monday that the plaintiffs fell short of their burden to show the malicious intent, disregard for safety or egregiously wrongful acts necessary to merit punitive damages.”  Law360

“Mr. Thorpe’s injuries required him to undergo multiple surgeries to repair the damage caused by the defective hernia patch, injuries from which he continues to suffer due to the serious nature of the physical damage caused by the patch. The jury found that the defendants proximately caused Mr. Thorpe’s injuries by failing to provide adequate warning or instruction for the hernia repair patch and acting unreasonably in designing the patch. The jury also found that the defendants’ negligence proximately caused Laure Thorpe to lose the consortium of her husband as a result of his injuries and subsequent physical and emotional suffering.” http://www.prweb.com/releases/2010/08/prweb4439564.htm#

“Law360, New York (July 1, 2011, 3:24 PM EDT) — C.R. Bard Inc. said Thursday it had tentatively agreed to pay $184 million to settle the majority of claims in a Rhode Island multidistrict litigation over allegedly defective hernia patches. In a U.S. Securities and Exchange Commission filing, the medical equipment manufacturer said it had reached agreements in principle with scores of plaintiffs who claim they suffered significant injuries because of faulty Composix Kugel surgical mesh patches manufactured by Bard subsidiary Davol Inc.” Law 360 

On July 15, 2010 The FDA determined that VENTRALIGHT ST MESH,  a Class II Surgical Mesh, is Substantially Equivalent (SESE) to the predicate device of Sepramesh IP Bioresorbable Coating/Permanent Mesh (K040868, K053066, K063739) 510k summary

The FDA approved Bard / Davol’s 510(k) premarket notification and approved VENTRALIGHT ST MESH to be marketed to the general public. The device description in the 510(k) summary for VENTRALIGHT ST MESH was “The Ventralight ST Mesh is a low profile, sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.” Id.

2011- Bard opens up pocket book and pays peanuts to several thousand victims who each filed a hernia mesh lawsuit


July 11, 2011
:  “C.R. Bard has reportedly reached an agreement to settle Kugel hernia mesh lawsuits brought by about 2,600 people who experienced severe internal injuries caused by problems with their hernia repair patches, with in an average payout of about $70,000 for each plaintiff. However, the settlement still leaves around 1,000 claims unresolved….” Id. These settlements were negotiated by top hernia mesh product liability attorneys.2011

“Law360, New York (July 1, 2011, 3:24 PM EDT) — C.R. Bard Inc. said Thursday it had tentatively agreed to pay $184 million to settle the majority of claims in a Rhode Island multidistrict litigation over allegedly defective hernia patches. In a U.S. Securities and Exchange Commission filing, the medical equipment manufacturer said it had reached agreements in principle with scores of plaintiffs who claim they suffered significant injuries because of faulty Composix Kugel surgical mesh patches manufactured by Bard subsidiary Davol Inc.”https://www.law360.com/articles/255403/bard-offers-184m-to-settle-hernia-patch-suits 

2014- Here comes the Bard Perfix Plug

October 08, 2014 Bard PerFix Light Plug was subject to a Class 2 Device Recall.The Manufacturer Reason for this Mesh, surgical, polymeric Recall was “The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug”

The FDA’s description of the issue was a bit more simplistic, describing the problem as “Error in labeling.” As a result of the recall, Davol took the following action: “Davol Inc. (Subsidiary of C.R. Bard, Inc) sent Customer Notification letters on Friday, October 10, 2014, via FedEx next day delivery with signature confirmation to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.” Id.

Cases we are reviewing for hernia mesh victims:

Covidien:(Formerly Tyco)

Atrium:

Bard/ Davol

  • Visilex
  • Composix
  • Composix EX
  • Spermatex
  • 3D Max (no 3D Max Lite)
  • Sepramesh
  • Perfix Plug
  • Ventralex
  • Kugel (criteria – confirmed ring break and revision)

Many victims are wondering:

  • Can I file a hernia mesh lawsuit?
  • What do I need to know before I file a hernia mesh lawsuit?
  • How can I get a hernia mesh settlement?
  • Will there be a hernia mesh settlement 2018?
  •  Will I have hernia mesh symptoms and complications years later?

Drug Safety News devastating assessment of Bard Davol:

According to Drug Safety News: “It isn’t the first time C.R. Bard has run afoul of the law. In 1993, the company pleaded guilty to 391 criminal charges involving defective catheters that had been illegally modified and sold without regulatory approval. Three company executives were convicted and jailed on charges of fraud and conspiracy, and Bard wound up paying $61 million in fines and penalties. More recently, the company has been called to account over pelvic meshes and IVC filters.

In Drug Safety News opinion: “The latest fiasco with Kugel Meshes clearly demonstrates that C.R. Bard is a repeat offender. Unfortunately, because Bard is a “corporate” person and not a natural human, there is no way to jail it and make sure it doesn’t harm anyone else.” https://drugsafetynews.com/2017/04/24/bard-medical-defective-hernia-patches/

Information about Bard hernia Mesh provided by a hernia mesh lawyers:

According to  My drug Justice: “Mesh products that have reports of serious problems and were manufactured by Davol C.R. Bard include:

  •      Bard 3D Max Inguinal Hernia Mesh
  •      Bard Davol Supramesh Composite
  •      Composix Kugel Mesh Patch
  •      Bard Ventralex ST Hernia Patch
  •      Bard Mesh PerFix Plug” Baron and Budd

Hernia surgery is one of the most common types of surgeries that are performed. It is estimated that every year as many as 750,000 people undergo hernia repair surgery. When a patient is diagnosed with a hernia surgery is the only permanent treatment possible. While some patients may be able to wait to determine the severity of the situation, in many cases surgical care is needed to resolve the problem and keep it from worsening. Mesh patches are often necessary in hernia repair.

Repair of small incisional hernias, of less than 3 centimeters, are able to be repaired with the patient’s tissue. Larger hernias require the use of prosthetic materials such as mesh to provide a repair that is tension-free. Some of these materials are synthetic and may cause a host of complications when used in hernia surgeries.

Mesh Patches Made of Marlex Polypropylene

Patches made of Marlex polypropylene are designed to be used in laparoscopic hernia surgery. The material is flexible so that it can be folded to fit into a small incision. Once inside, it is opened to expand so that it covers the desired area. Unfortunately, there have been many medical problems and complications for patients with C.R. Bard mesh patches and others.

Marlex polypropylene is a type of manmade material that is non-absorbable. This means that the body does not absorb it, so it never disintegrates into the body. Instead, it remains in its original structure, although it may break, move, or weaken during use. The result is a hernia solution that can cause medical problems for patients.

History of C.R. Bard Mesh Patches

Mesh patches are utilized to strengthen the area of repair. Hernia surgery has become more common over the last 30 years since various repair materials have been more readily available. Flexible sheets of materials are manufactured to be used as support for the repair. Polypropylene is a synthetic material that is not absorbable by the body. Therefore, it can cause some complications once it has been put into place.

The most common problems that occur in patients from the use of mesh patches are migration and erosion. Migration happens when the mesh patch moves or changes position inside the body. This can occur when tissues grow around the patch and push it out of place. The patch can actually move into a position where it can damage the intestines or create a blockage. Patches may also erode over time, creating the need for additional surgery to repair the hole that is left.

Complications from Mesh Patch Use:

Although not everyone suffers complications, many people have reported injuries and complications.  Many victims have filed hernia mesh lawsuits as a result of these serious symptoms and mesh complications. The most common hernia mesh complications include:

  • Pain
  • Swelling
  • Adhesions
  • Infections
  • Migration of mesh
  • Obstructions

Complications may occur at any time after surgery but are most likely to happen months or years after the original surgical hernia repair was completed. Those who suffer from subsequent pain or other symptoms should immediately seek medical treatment. A complete doctor’s examination and diagnosis will determine the cause of the problem. Subsequently, the patient must be treated for complications due to the use of a mesh hernia patch.

Treatment of Complications

When a patient presents with a medical complication from a hernia mesh implant the cause of the problem may not be immediately known. Some symptoms may not appear for months or even years after the initial surgery. A different doctor may evaluate the patient, and the type of mesh implant that was inserted may not be noted. These details can make it difficult to evaluate and treat the patient.

Immediate care typically involves the use of pain medication and prescriptions to reduce inflammation. Once a diagnosis has been made, the patient will most likely require surgery to assess the internal damage and make the necessary repairs. The surgeon may try to remove at least part of the original patch; however, this can be difficult to do because the body’s tissue grows onto it. Instead, some of the patch will be taken out, and repairs will need to be done, sometimes using additional mesh products.

Recall of Surgical Mesh | Hernia mesh lawsuit

C.R. Bard mesh patches have been reported to cause injuries to some patients. Injuries range in severity, and some are life threatening. The injuries were caused allegedly by defects in the mesh material that caused the product to shift or move inside the body or to break while implanted. The result may be a puncture to the bowel, an obstruction to the intestines, an infection, or other problems that can be severe. The U.S. Food and Drug Administration, FDA, requires companies to follow strict guidelines for testing and product safety. Any complications should be reported to the FDA by both the patient and physician. In addition, patients may seek compensation by filing a lawsuit.

Litigation History and Current Status | Hernia mesh lawsuit

C.R. Bard manufactures a number of different types of mesh implants. Complications have been reported with the use of Kugel Hernia Mesh, 3D Max, PerFix Plug, Ventralex ST Hernia Mesh and Sepramesh. The company still manufactures and sells these products. Various lawsuits have been filed against the company for injuries sustained by the use of mesh hernia implants. The lawsuits are based on the fact that the company was made aware of medical problems but did not take action to prevent further injuries from occurring. Additionally, the company did not properly warn patients of the potential for injuries caused by the use of mesh hernia products. Nothing was done to correct possible product defects.

Those who were injured because of complications from the use of hernia mesh should speak with a hrnia mesh attorney as soon as possible. Victims may be entitled to compensation for medical and other expenses that were incurred because of the defective products. To qualify for a lawsuit an individual must have received a mesh implant as part of original hernia surgery and then later suffered from complications. Medical documentation is necessary to show that the complications were a result of a defective implant. Individual lawsuits are possible, or there may be class action lawsuits that victims may take part in.

The FDA speaks

“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.” FDA

Please contact a hernia mesh lawyer for legal representation. A hernia mesh lawyer will help you get justice and compensation by either a judgment or settlement for your hernia mesh complications/revision surgery. Many victims are wondering if there will be a surgical mesh settlement 2017 or hernia mesh settlements 2018. Other victims are wondering what the average settlement amount is for a hernia mesh lawsuit.’

Hernia mesh lawsuits have been filed across the United States. Many of these lawsuits have been consolidated in Multi District Litigation (MDL). Here are some of the most significant Multi District Litigation:

  • MDL No. 1842 | In Re: Kugel Mesh Herniamedical device liability
    Repair Patch Litigation UNITED STATES DISTRICT COURT
    FOR THE DISTRICT OF RHODE ISLAND
  • MDL No. 2753 | In Re: Atrium Medical Corp. C-Qur Mesh
    Products Liability Litigation,  UNITED STATES DISTRICT COURT
    FOR THE DISTRICT OF NEW HAMPSHIRE
  • MDL No. 2782 | In RE: Ethicon Physiomesh Flexible
    Composite Hernia Mesh Products Liability Litigation, United States District Court for the Northern District of Georgia

What is a hernia?

“A hernia occurs when an organ pushes through an opening in the muscle or tissue that holds it in place. For example, the intestines may break through a weakened area in the abdominal wall. Hernias are most common in the abdomen, but they can also appear in the upper thigh, belly button, and groin areas. Most hernias aren’t immediately life-threatening, but they don’t go away on their own. Sometimes they can require surgery to prevent potentially dangerous complications.” healthline