Below you will find excerpts of three actual complaints filed in hernia mesh lawsuits. The real names and dates have been changed to protect the privacy of the victims. Other details remain unchanged.
Victim: Jane Johnson
Type of mesh:
- Composix Kugel Mesh Patches (“Kugel Patch”)
Jane Johnson’s case history (Exact quotes from actual complaint):
- On or about October 19, 2007, Ms. Johnson had an incisional hernia repair performed at Gaston Memorial Hospital in Gastonia, North Carolina. Ms. Johnson had a Composix Kugel Patch implanted during this procedure by Dr. Eric.”
- After having the defective Composix Kugel patch implanted, Ms. Johnson began experiencing severe abdominal pain and, on December 19, 2015 suffered a major gastrointestinal bleeding event which was found to be the result of the eroding mesh in the fundus of Ms. Lee’s stomach. This failure ultimately disallowed for the safe surgical removal of the defective Composix Kugel Patch that was causing Ms. Johnson’s complications.
- Jane Johnson has suffered and will continue to suffer physical pain and mental anguish.
- Jane Johnson has incurred substantial medical bills and Ms. Lee has suffered loss of other monies.
- Jane Johnson suffered severe emotional distress, which was as a result of DAVOL’s and BARD’s negligent conduct in failing to adequately and safely design and construct an effective and safe Composix Kugel Patch for hernia repair surgery.
- Ms. Johnson suffered severe emotional distress, which was as a result of DAVOL’s and BARD’s extreme outrageous, intentional, willful, and reckless conduct in failing to adequately and safely design and construct an effective and safe Composix Kugel Patch for hernia repair surgery, in complete and reckless disregard of safety to Ms. Johnson.
Factual allegations (all actual quotes from complaint)
- On December 22, 2005, DAVOL recalled many sizes of Composix Kugel Patches under a Class I recall notice.
- The Composix Kugel Patch was recalled due to a faulty “memory recoil ring” that can break under pressure. Incidents of ring migration, intestinal fistulae, bowel perforation and even death have been reported.
- The FDA conducted the aforementioned EIR investigations in January and February of 2006. The results of these investigations determined, among other things, that BARD and DAVOL: had excluded ring failure events which should have been included from their complication database, reports, and recall notices;
- misidentified numerous Kugel Patch complication events;
- failed to apply the product quality hold and release procedure on a timely basis;
- failed to properly follow the procedures for conducting design validation review;
- failed to identify all the actions necessary to correct and prevent the recurrence of further ring break and Kugel Patch complications; specifically, they provided no justification for including only the Extra Large Kugel Patch sizes in the December 2005 recall;
- failed to provide full information which they knew regarding numerous Kugel Patch complaints;
- failed to actually perform strength testing on memory recoil rings for all sizes of Kugel patch before putting them into the stream of commerce;
- failed to maintain appropriate sources for quality data to identify, track, and trend existing and potential causes for the ring failures and Kugel Patch complaints resulting in numerous inconsistencies and errors in the raw data and from the actual complaints and what was placed in the electronic databases.
VICTIM: DOROTHY JOHNSON
(All quotes FROM ACTUAL complaint below)
Type of mesh:
- Ventralex is a multi-layer polypropylene and expanded polytetraflouroethylene patch marketed by Defendants, as a mesh to be used in repairing hernias and to provide extra reinforcement to the hernia defect. Defendants’ Ventralex product contains two layers of polypropylene mesh.
- Defendants’ Ventralex product contains two layers of polypropylene mesh. Despite claims that this material is inert, a substantial body of scientific evidence shows that this mesh material is biologically incompatible with human tissue and promotes an immune response in a large subset of the population receiving these products. This immune response promotes degradation of the polypropylene mesh, as well as the surrounding tissue, and can contribute to the formation of severe adverse reactions to the mesh.
- DAVOL and BARD at all times mentioned knew or in the exercise of reasonable care should have known, that the Ventralex Hernia Patches were of such a nature that they were not properly manufactured, tested, inspected, packaged, labeled, distributed, marketed, examined, sold, supplied, prepared and/or provided with the proper warnings, and were unreasonably likely to injure Ventralex Hernia Patch users.
- DAVOL and BARD so negligently and carelessly designed, manufactured, tested, failed to test, inspected, failed to inspect, packaged, labeled, distributed, recommended, displayed, sold, examined, failed to examine and supplied the Ventralex Hernia Patch, that they were unreasonably dangerous and unsafe for the use and purpose for which it was intended.
- DAVOL and BARD were aware of the probable consequences of the Ventralex Hernia Patch. DAVOL and BARD knew or should have known the Ventralex Hernia Patch would cause serious injury and they failed to disclose the known or knowable risks associated with the Ventralex Hernia Patch. Furthermore, DAVOL and BARD willfully and deliberately failed to avoid those consequences, and in doing so, DAVOL and BARD acted in conscious disregard of the safety of Dorothy Johnson
- Defendants DAVOL and BARD owed a duty to Dorothy Johnson to adequately warn her and her treating physicians of the risks of degradation, infection, contracture, shrinkage, breakage, separation, tearing and splitting associated with the Ventralex Hernia Patch and the resulting harm and risk it would cause patients.
- Defendants DAVOL and BARD breached their duty by failing to comply with state and federal regulations concerning the study, testing, design, development, manufacture, inspection, production, advertisement, marketing, promotion, distribution, and/or sale of the Ventralex Hernia Patch.
- As a direct and proximate result of the duties breached, the Ventralex Hernia Patch used in Dorothy Johnson’s s hernia repair surgery failed, resulting in much pain and suffering, mental anguish, doctor visits, subsequent procedures, and death.
- The Ventralex was properly implanted in the abdomen and sutured circumferentially,
- At the time of her operation, Dorothy Johnson was not informed of, and had no knowledge of the complaints, known complications and risks associated with Ventralex.
- Dorothy Johnson was never informed by Defendants of the defective and dangerous nature of Ventralex.
- At the time of her implant, neither Dorothy Jonson nor her physicians were aware of the defective and dangerous condition of Ventralex.
- Sometime after placement the device malfunctioned by, inter alia, contracting, suffering degradation, causing an intense foreign body and inflammatory response, as well as sepsis and death.
- The Ventralex Hernia Patch was sold in a defective condition by design and manufacture;Plaintiff;
- The Ventralex Hernia Patch as designed and manufactured was unreasonably dangerous to Plaintiff;
- DAVOL and BARD failed to warn the end user about the dangers and risks of the product;end user;
- Failing to implement an adequate, safe and effective “memory recoil ring” and/or its interaction with the mesh of the Ventralex Hernia Patch to withstand the foreseeable stresses they would be subject to within the intra-abdominal space;
- The Ventralex Hernia Patch did not perform safely as an ordinary consumer/patient, like Plaintiff, would expect;
- Failing to avoid migration of the Ventralex Hernia Patch and/or its components from the initial site of the hernia repair surgery.
- DAVOL and BARD knew the component parts of the Ventralex Hernia Patch as implemented through design and/or manufacture could cause injury to the
- The Ventralex Hernia Patch as designed and manufactured was unsafe for its intended use;
- The Ventralex Hernia Patch as designed and manufactured was unsafe to
VICTIM- SCOTT SANDERS
(excerpt from actual lawsuit- name changed to protect privacy)
Mesh: Bard Mesh PerFix Plug
- PerFix Plug is a three-dimensional device containing layers of polypropylene with a separate pre-shaped onlay polypropylene patch, and it is marketed by Defendants as a mesh to be used in repairing groin hernias.
- Defendants’ PerFix Plug product contains several layers of polypropylene mesh. Despite claims that this material is inert, a substantial body of scientific evidence shows that this mesh material is biologically incompatible with human tissue and promotes an immune response in a large subset of the population receiving these products. This immune response promotes degradation of the polypropylene mesh, as well as the surrounding tissue, and can contribute to the formation of severe adverse reactions to the mesh.
- PerFix Plug contains the following components: 1) several layers of polypropylene constructed as a fluted outer layer with multiple inner layers, and 2) one layer of pre-shaped polypropylene mesh to be implanted as an onlay over the plug once implanted.
- The polypropylene mesh used in the manufacture the PerFix Plug, which was implanted into SCOTT SANDERS is not suited for implantation into the human body due to its small pore size and weave, high volume of material utilized, selection of polypropylene resin, and other design features. These design aspects lead to adverse tissue reactions in the body, which directly lead to complications.
- The PerFix Plug implanted in Plaintiff was designed, manufactured, sold and distributed by Defendants to be used by surgeons for groin hernia repair surgeries and was further represented by Defendants to be an appropriate, cost-effective and suitable product for such purpose.
- The polypropylene mesh used in the manufacture of the PerFix Plug, which was implanted into SCOTT SANDERS, is unreasonably dangerous, defective, and negligently designed in the following ways:
- Sometime after placement, the device malfunctioned by, inter alia, contracting,suffering degradation, and causing an intense foreign body and inflammatory response. As a result of these failures, Plaintiff has suffered severe injuries and required medical care.