Inguinal plugs are made from polypropylene material. As polypropylene oxidizes it becomes more rigid and brittle, which often leads to erosion. These plugs utilize more polypropylene material per unit area of defect than flat mesh, which means they are subject to faster oxidation and more inflammation. This along with their three-dimensional plug shape promotes contracture and migration.
Polypropylene is made up of both Crystalline segments, which are rigid, and Amorphous segments which are flexible. The Amorphous segments are more susceptible to oxidation and are the first to erode. Over time this process results in only the Crystalline segments remaining and the mesh loses its flexibility. When this happens, the mesh becomes harder than the surrounding tissues and with movement the tissue gives way to the mesh. This process causes the mesh implant to erode and migrate.
Three different manufacturers have popular polypropylene plug designs: Bard, Ethicon and Atrium. Bard makes the Prefix Plug, Ethicon makes a plug that is part of the Prolene Hernia Mesh System, and Atrium makes the Proloop plug. All of these designs are made from this potentially harmful polypropylene material.
Two specific design factors contribute to an increased inflammatory response; the amount of polypropylene material in these implants and their shape. When human tissue encounters a foreign body it often causes an inflammatory response. The increased volume of polypropylene material contained in these implants often results in more inflammation. Also the three dimensional shape of these implants exposes a larger surface area of tissue to the polypropylene material. When this type of inflammatory response occurs it creates fibrin tissue and results in the formation of scar tissue. When fibrinous tissue bridges the pores of the mesh the filaments are pulled together and cause the mesh to contract.
Composite Ventral patches were designed specifically for the purpose of ease of implantation; not safety and effectiveness. The unique design aspects of these patches make them easier to implant in the hands of less skilled surgeons. They are designed to be intraperitoneal allowing them to be placed next to the bowel and alleviating the need to access one of the extraperitoneal planes. Also, the flexible internal rings eliminate the need to painstakingly assure the mesh is flat and flush with the abdominal wall and properly tensioned.
In order to facilitate the ease of placement with these patches they contain adhesion barriers. Adhesion barriers are a resorbable layer separating the mesh from the tissue. Different manufacturers use different adhesion barriers. For instance, the Atrium C-Qur mesh product uses fish oil, Ethicon’s Proceed product utilizes cellulose and Bard’s Ventralex ST uses hyaluronic acid. All of these constitute additional foreign material that can cause inflammation. When the resorbable layer goes away it leaves the bowel in direct contact with the polypropylene material while in the presence of augmented inflammation. This can result in adhesions of the polypropylene to the bowel resulting in entrapment, perforation, fistula and recurrence. The designs of these plugs and the patches are causing many of them to fail prematurely and resulting in an increased rate of complications, often leading to additional surgeries.
If you or a loved one have suffered from pain, infection, organ damage or hernia reoccurrence leading to subsequent surgery you may be entitled to compensation. Please contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner.
Complete the Free Case Review form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
C.R. Bard, Inc. (Davol) is a worldwide leader in the $600 million-dollar hernia mesh industry. They maintain one of the broadest and deepest product lines in the industry and they are a major profit source for the company making up 17% of its net total sales. Much of their market share success is the result of their innovative marketing programs that consist of surgeon training and patient education and awareness.
Many of Bard’s products use heavyweight mesh combined with Polytetrafluoroethylene (ePTFE). The intended goal of heavyweight mesh is to achieve maximum stability by closing the defect with a stiff device that maximizes scar tissue. However, physiologically the mechanical stability of heavyweight mesh it too high, exceeding that of the abdominal wall. Consequently, it results in fibrosis and leads to stiffening of the implant as oppose to increased mechanical stability. This, along with its smaller pore size causes a greater inflammatory response and exposes patients to unnecessary risks, such as greater scar tissue formation, decreased graft compliance, decreased tissue incorporation, increased graft shrinkage and increased pain and discomfort. Some animal studies have found the graft shrinkage with this type of heavyweight mesh to be greater than 50%.
Additionally, the type of polypropylene mesh that Bard uses is not intended for medical application. Different companies supply polypropylene material that is used in hernia mesh implants. Bard gets its polypropylene from the Phillips Sumika Polypropylene Company. Phillips Sumika provides a medical application caution along with its polypropylene. It specifically warns against using its material in medical applications involving permanent implantation in the human body or permanent contact with internal bodily fluids or tissues. The Phillips Sumika safety data sheet states that its polypropylene material should not be used in human implants unless it has been provided directly form the company under an agreement which expressly acknowledges such contemplated use.
In addition to being made from these harmful materials, a number of Bard implants are accompanied with specific selling features that can be harmful. For instance, Bard Kugel patches, which were FDA cleared in 2002, have memory coil rings that allow the patch to be folded and inserted through a small abdominal incision and, once in place, they spring open helping the mesh lay flat over the affected area. However, this design has been associated with many problems such as the rings buckling and rupturing. Shrinkage and migration of this mesh is also a common problem that has been reported. Another poorly designed Bard product is their Composix E/X and Composix mesh. This implant consists of two distinct sides, one that is polypropylene (PP) and the other that is ePTFE. This product is associated with a high rate of adhesions for several reasons. One, the heavy weighted PP induces a large inflammatory process that leads to fibrosis. Further, this mesh cannot be cut without widely exposing the PP layer. In addition, the holes in the ePTFE side of the mesh made by the stiches create adhesions. Bard’s Ventralex product, which was also cleared by the FDA in 2002, has similar design problems as described with its Composix products. The heavyweight PP and the ePTFE are mismatched materials because they contract at different rates making them mechanically incompatible. All of these design flaws lead to further complications and often times require the patient to undergo additional surgeries.
Goldman, Scarlato & Penny are investigating the following Bard/Davol mesh products:
If you or a loved one have suffered from pain, infection, organ damage or hernia reoccurrence leading to subsequent surgery you may be entitled to compensation. Please contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner.
Complete the Free Case Review form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
Hernia mesh has been utilized in surgical operations since the 1960s. Over the years there have been many different design variations and materials used in the manufacturing of these implants. The three main material groups are polypropylene (PP), polytetrafluorethylene (PTFE) and Polyester (POL). PP is a hydrophobic polymer of carbon atoms with alternating methyl moieties. It is a flexible but strong material that is easily cut and integrates with surrounding tissue while remaining resistant to infection. PTFE is a chemically inert synthetic fluoropolymer that does not incorporate into human tissue and becomes encapsulated, which increases the chances of hernia recurrence. It is also micro porous which allows bacteria passage. These problems led to the expansion of PTFE to become a uniform, fibrous and a micro porous structure with improved strength that is known as ePTFE. POL is a carbon polymer of terepthalic acid and can be fashioned into strong fibers suitable to be woven into a prosthetic mesh.
An ideal synthetic mesh is biocompatible, strong, resistant to infection, non-immunogenic and results in minimal bioreactivity. Tissue incorporation is the goal and depends on factors such as material, density, construction, filament type, pore size and compliance. For instance, mesh implants with larger pores allow for tissue ingrowth and are more flexible because they avoid granuloma bridging. Granulomas can form around individual mesh fibers when there is a foreign body reaction. They typically occur when the pore size is small and can cause a stiff scar plate and reduced flexibility of the mesh. The weight of the mesh is another characteristic that affects its performance. Heavyweight meshes use thick polymers, have small pore size and high tensile strength. As where lightweight meshes are composed of thinner filaments and have larger pores. Typically, lightweight meshes contain less material which initiates less of a foreign body reaction and are more elastic. Contraction occurs with all mesh products and can be problematic if there is too much contraction and becomes restrictive. There is a direct correlation between the degree of inflammatory response and contraction. Thus, lightweight tissue that causes a lesser degree of inflamation will have less contraction.
Elasticity and mesh strength is also an important factor that determines the performance of the mesh implant. If the mesh is too flexible and weak it will increase the risk of hernia reoccurrence. However, the mesh must be flexible enough so that the natural flexibility of the abdominal wall is preserved. If the mesh is too restrictive it will resist abdominal distension which can be painful and could result in the mesh breaking. The strength of the mesh depends on the filament type (multi-or mono-), woven or knitted, and the polymer type. Knitted meshes have greater flexibility and larger pores but are not as strong as woven meshes. Knitted meshes can be stretched in any direction as where woven meshes only stretch in one direction.
The latest mesh designs are composite meshes which are made from more than one material. The advantages of these meshes is that they can be used in the intraperitoneal space with minimal adhesion formation. However, in most instances, the safety and efficacy of these combined materials have not been sufficiently tested. These meshes have distinct sides; a visceral side and non-visceral side. The visceral side has a micro porous surface to prevent visceral adhesions and the non-visceral side is often macro porous to allow tissue ingrowth. All of these typically use either PP, POL or ePTFE combined with an additional material such as titanium, omega 3, monocryl, polyvinylidene fluoride or hyaluronate. There are two categories, either absorbable or permanent. Typically, barrier coatings in absorbable composite meshes require hydration prior to use and cannot be cut. Parietex composite mesh was the first to offer a resorbable collagen barrier on one side to limit visceral attachment and a polyester knit structure on the other side to promote tissue ingrowth. These coatings can cause bacteria entrapment that leads to bad infections. Other problems that have been associated with some of these implants has been mesh migration, folding over or balling up. Several manufacturers such as Ethicon, Bard/Davol, Atrium, and Covidien have composite meshes,
If you or a loved one have suffered from pain, infection, organ damage or hernia reoccurrence leading to subsequent surgery you may be entitled to compensation. Please contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner.
Complete the Free Case Review form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
There are a number Covidien hernia mesh implants that appear to be poorly designed. While some mesh implants effectively treat hernias, others can cause complications that often lead to additional surgeries. Below is a list of Covidien mesh implants that GSP is investigating:
Parietex
Parietex Composite (PCO)
Symbotex
Surgipro
Parietene
Parietene Macroporous
Progrip
Parietex Progrip
Parietex Plug and Patch
Parietene Progrip
The universe of hernia mesh implants is comprised of many different types of products that are made from different materials, utilize different substances as layers of film, have different pore sizes, use different attachment mechanisms, and come in a variety of shapes and sizes. All of these variables play a factor in the safety and effectiveness of these implants and many of them were never tested for safety and effectiveness before being marketed for use in hernia surgeries.
For instance, Parietex mesh is made from polyester and has a layer of collagen film that disintegrates over time and fails to protect against exposure to the polyester material. This, along with its rough edges, leads to perforation of surrounding organs and tissues, infections, and dense bowel adhesions. The lightweight version of this mesh with large pores also has problems with the mesh implant failing as a result of it breaking or tearing.
Covidien’s Symbotex Composite mesh is similarly made from polyester textile and covered with absorbable hydrophilic film on both sides. The layer of film on this product consists of collagen from porcine origin and glycerol. This mesh implant claims to provide long term reinforcement of soft tissues while the absorbable film minimizes tissue attachment to the mesh in the event of direct contact with the viscera. Similar problems have been seen with this implant as those described with the Parietex implant.
The Paritex ProGrip mesh has a unique design consisting of thousands of microgrips that replace the need for alternative tacks or sutures. The fixation of this mesh is akin to that of velcro. Once this implant is placed it cannot be moved. This type of inflexible fixation leads to tearing, fraying and unraveling of the mesh which can cause incredible pain, perforation of surrounding tissue and organs, and a pulling or tugging sensation. Some have reported a foreign body response with this implant.
The Parietex Plug and Patch system is a plug-like design made from mesh. This implant is specifically indicated for the treatment of groin hernia defects used in an open approach. The World Guidelines for Groin Hernia Management have warned against the use of plug repair techniques because they are associated with higher rates of migration and erosion.
If you or a loved one have suffered from pain, infection, organ damage or hernia reoccurrence leading to subsequent surgery you may be entitled to compensation. Please contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner.
Complete the Free Case Review form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
A clinical trial (terminated in early 2014 due to safety concerns) found that Ethicon’s Physiomesh, had unacceptably high rates of reoccurrence and postoperative complications. The FDA cleared Physiomesh for marketing in 2010 under its 510(k) “substantially equivalent” approval mechanism. Under the 510(k) process manufacturers are permitted to market medical devices so long as they show they are substantially equivalent to another medical device that is already on the market. FDA 510(k) clearance does not require manufacturers of medical devices to perform clinical trials to determine the safety and efficacy of a new medical device before they are released onto the market. Thus, no clinical trials had been performed on the Physiomesh device when it was released in 2010. The clinical trial on this device did not come until four years later.
In 2014 the Polish Hernia Study Group sponsored a clinical study intended to compare two different fixation techniques for hernia mesh in laparoscopic ventral repairs. The researchers compared the Physiomesh/Securestrap and Ventralight ST/SorbaFix mesh products with respect to pain. It was a single-center, prospective randomized study, a study protocol which is at the top of the hierarchy of evidence paradigm. The study was intended to include 50 patients per group with interim analysis for safety after 25 patients. The safety parameters included the number of recurrences and postoperative complications. However, at the interim analysis the study was abruptly terminated because of safety concerns. The researchers observed a 20% recurrence rate with the Physiomesh group in the first 6 months. They also found a significantly higher pain rate for the Physiomesh group at the 3-month point. Although the study could not be completed because of these safety concerns, the researchers concluded that these interim findings confirmed the superiority of elastic mesh, which was found to be safer and more efficacious for laparoscopic ventral hernia repairs. Despite being aware of these severe adverse events associated with the Physiomesh product in 2014, Ethicon waited until May 2016 before withdrawing the product from the market.
Physiomesh implants are made up of three materials. The core is prolene polypropylene mesh with 3mm pores and a polydioxanone film on top. This film is supposed to act as a gluing agent between the mesh and monocryl film, which is the top layer of the mesh. This design is unique in that it consists of polypropylene sandwiched between layers of thick polymer films. The outer layer of film prevents adequate tissue ingrowth with the mesh allowing it to move, migrate or ball-up. Additionally, the large pore, small filaments design makes this mesh too weak causing it to rupture and for the hernia to reoccur. These design flaws are consistent with the severe adverse events that were observed in the clinical trials. Studies have also shown that these films can act as absorbable barriers that provide an adequate environment for bacterial adherence, niche formation and biofilm development due to the large surface area provided by the barrier sheet. As a result, a large surface area is prone to the colonization of bacteria that can lead to persistent infection. Many of these complications cause patients debilitating pain and often lead to subsequent surgeries.
If you or a loved one have suffered from pain, infection, organ damage or hernia reoccurrence leading to subsequent surgery you may be entitled to compensation. Please contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner.
Complete the Free Case Review form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
Over the past couple of years Maquet Holding B.V. & Co. and its subsidiary, Atrium Medical Corporation, have come under fire for failing to meet FDA safety standards when it comes to the design and manufacturing of their C-Qur hernia mesh product. Between 2009 and 2013 the FDA conducted ten inspections across three of the Maquet manufacturing facilities. Those inspections uncovered major Quality System, Medical Device Reporting, and Correction and Removal violations that resulted in the FDA halting the manufacturing of C-Qur mesh implants.
The FDA first sent a warning letter to Maquet in 2010, which detailed the identified violations and required that they be corrected to avoid further action. Maquet failed to make the required changes and in 2012, the FDA sent another warning letter to the corporation. In this letter, they detailed the problems with sterilization, complaint follow-up, safety trials and general non-compliance, which were found during their investigations. The FDA sent a final warning letter in December 2014, which again detailed the company’s violations and their obligation to address these issues.
Maquet and Atrium failed to adequately respond to the FDA’s multiple warning letters. This led the FDA to file for a permanent injunction against Atrium Medical in February 2015. A federal judge form the U.S. District Court for the District of New Hampshire agreed with the FDA and entered a consent decree of permanent injunction against Maquet and three of its subsidiaries, including Atrium Medical Corporation, which manufactured and distributed C-Qur hernia mesh.
The consent decree orders that Maquet cease manufacturing and distributing devices from Atrium’s Hudson facility until that facility is in compliance with all regulations. The consent decree bans Maquet from making and selling the following Atrium products:
Although the injunction prevents Maquet from manufacturing and selling these products, unlike a recall it does not require the return of previously sold products and does not prevent healthcare facilities from using product that they already have in stock. For instance, several hospitals, who were able to purchase C-Qur mesh at cheap bulk prices before the injunction was entered, are still implanting this mesh in patient’s today, which is technically not a violation of the injunction order.
Cases against Atrium in connection to injuries allegedly sustained by C-Qur mesh, have been consolidated in a Multi-District Litigation (“MDL”) in the United States District Court of New Hampshire. Click here to visit the Atrium C-Qur Official MDL website and learn more about the status of this litigation.
If you or a loved one have suffered from pain, infection, organ damage or hernia reoccurrence leading to subsequent surgery you may be entitled to compensation. Please contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner.
Complete the Free Case Review form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
Certain Covidien hernia mesh implants appear to be poorly designed. Some mesh implants can cause complications that often lead to additional surgeries. GSP is investigating the following Covidien mesh implants:
If you or a loved one have suffered from pain, infection, organ damage or hernia reoccurrence leading to subsequent surgery you may be entitled to compensation. Please contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner.
Hernia mesh implants are comprised of many different types of products made from different materials utilizing different substances as layers of film, having different pore sizes, using different attachment mechanisms, and come in a variety of shapes and sizes. All of these variables play a factor in the safety and effectiveness of hernia mesh implants, and many of them were never tested for safety and effectiveness before being marketed for use in hernia mesh implant surgeries.
Covidien Parietex mesh is made from polyester and has a layer of collagen film designed to disintegrate over time. Reports show that the film fails to protect against exposure to the polyester material. This, along with its rough edges, can lead to perforation of surrounding organs and tissues, infections, and dense bowel adhesions. The lightweight version of Covidien Parietex mesh with large pores have been shown to fail as a result of it breaking or tearing.
Covidien Symbotex Composite mesh is made from polyester textile and covered with absorbable hydrophilic film on both sides. The layer of film on this product consists of collagen from porcine origin and glycerol. Covidien Symbotex claims to provide long term reinforcement of soft tissues while the absorbable film minimizes tissue attachment to the mesh in the event of direct contact with the viscera. Similar problems have been reported with Covidien Symbotex as those described with the Parietex implant.
Covidien Paritex ProGrip mesh claims to have a unique design consisting of thousands of microgrips that replace the need for alternative tacks or sutures. The fixation of this mesh is described as similar to Velcro. Once Covidien Paritex ProGrip is implanted, it cannot be moved. This type of inflexible fixation has resulted in reports of tearing, fraying and unraveling of the mesh which can cause incredible pain, perforation of surrounding tissue and organs, and a pulling or tugging sensation. Some patients have reported a foreign body response with Covidien Paritex ProGrip implants.
Covidien Parietex Plug and Patch is a plug-like design made from mesh. Covidien Parietex Plug and Patch was specifically indicated for the treatment of groin hernia defects. The World Guidelines for Groin Hernia Management have warned against the use of plug repair techniques because they are associated with higher rates of migration and erosion.
Complete the Free Case Review form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
Hernia mesh has been utilized in surgical operations since the 1960s. Over the years there have been many different design variations and materials used in the manufacturing of these implants. The three main material groups are polypropylene (PP), polytetrafluorethylene (PTFE) and Polyester (POL). PP is a hydrophobic polymer of carbon atoms with alternating methyl moieties. It is a flexible but strong material that is easily cut and integrates with surrounding tissue while remaining resistant to infection. PTFE is a chemically inert synthetic fluoropolymer that does not incorporate into human tissue and becomes encapsulated, which increases the chances of hernia recurrence. It is also micro porous which allows bacteria passage. These problems led to the expansion of PTFE to become a uniform, fibrous and a micro porous structure with improved strength that is known as ePTFE. POL is a carbon polymer of terepthalic acid and can be fashioned into strong fibers suitable to be woven into a prosthetic mesh.
An ideal synthetic mesh is biocompatible, strong, resistant to infection, non-immunogenic and results in minimal bioreactivity. Tissue incorporation is the goal and depends on factors such as material, density, construction, filament type, pore size and compliance. For instance, mesh implants with larger pores allow for tissue ingrowth and are more flexible because they avoid granuloma bridging. Granulomas can form around individual mesh fibers when there is a foreign body reaction. They typically occur when the pore size is small and can cause a stiff scar plate and reduced flexibility of the mesh. The weight of the mesh is another characteristic that affects its performance. Heavyweight meshes use thick polymers, have small pore size and high tensile strength. As where lightweight meshes are composed of thinner filaments and have larger pores. Typically, lightweight meshes contain less material which initiates less of a foreign body reaction and are more elastic. Contraction occurs with all mesh products and can be problematic if there is too much contraction and becomes restrictive. There is a direct correlation between the degree of inflammatory response and contraction. Thus, lightweight tissue that causes a lesser degree of inflamation will have less contraction.
Elasticity and mesh strength is also an important factor that determines the performance of the mesh implant. If the mesh is too flexible and weak it will increase the risk of hernia reoccurrence. However, the mesh must be flexible enough so that the natural flexibility of the abdominal wall is preserved. If the mesh is too restrictive it will resist abdominal distension which can be painful and could result in the mesh breaking. The strength of the mesh depends on the filament type (multi-or mono-), woven or knitted, and the polymer type. Knitted meshes have greater flexibility and larger pores but are not as strong as woven meshes. Knitted meshes can be stretched in any direction as where woven meshes only stretch in one direction.
The latest mesh designs are composite meshes which are made from more than one material. The advantages of these meshes is that they can be used in the intraperitoneal space with minimal adhesion formation. However, in most instances, the safety and efficacy of these combined materials have not been sufficiently tested. These meshes have distinct sides; a visceral side and non-visceral side. The visceral side has a micro porous surface to prevent visceral adhesions and the non-visceral side is often macro porous to allow tissue ingrowth. All of these typically use either PP, POL or ePTFE combined with an additional material such as titanium, omega 3, monocryl, polyvinylidene fluoride or hyaluronate. There are two categories, either absorbable or permanent. Typically, barrier coatings in absorbable composite meshes require hydration prior to use and cannot be cut. Parietex composite mesh was the first to offer a resorbable collagen barrier on one side to limit visceral attachment and a polyester knit structure on the other side to promote tissue ingrowth. These coatings can cause bacteria entrapment that leads to bad infections. Other problems that have been associated with some of these implants has been mesh migration, folding over or balling up. Several manufacturers such as Ethicon, Bard/Davol, Atrium, and Covidien have composite meshes,
If you or a loved one have suffered from pain, infection, organ damage or hernia reoccurrence leading to subsequent surgery you may be entitled to compensation. If you believe you or a loved one may have a claim, contact us today. There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner.
Complete the form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
Melissa Fry Hague
For your FREE CASE REVIEW fill out the below information and we will be in contact with you within the next 24 hours:
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C.R. Bard, Inc. (Davol) is a worldwide leader in the $600 million-dollar hernia mesh industry. They maintain one of the broadest and deepest product lines in the industry and they are a major profit source for the company making up 17% of its net total sales. Much of their market share success is the result of their innovative marketing programs that consist of surgeon training and patient education and awareness.
Many of Bard’s products use heavyweight mesh combined with Polytetrafluoroethylene (ePTFE). The intended goal of heavyweight mesh is to achieve maximum stability by closing the defect with a stiff device that maximizes scar tissue. However, physiologically the mechanical stability of heavyweight mesh it too high, exceeding that of the abdominal wall. Consequently, it results in fibrosis and leads to stiffening of the implant as oppose to increased mechanical stability. This, along with its smaller pore size causes a greater inflammatory response and exposes patients to unnecessary risks, such as greater scar tissue formation, decreased graft compliance, decreased tissue incorporation, increased graft shrinkage and increased pain and discomfort. Some animal studies have found the graft shrinkage with this type of heavyweight mesh to be greater than 50%.
Additionally, the type of polypropylene mesh that Bard uses is not intended for medical application. Different companies supply polypropylene material that is used in hernia mesh implants. Bard gets its polypropylene from the Phillips Sumika Polypropylene Company. Phillips Sumika provides a medical application caution along with its polypropylene. It specifically warns against using its material in medical applications involving permanent implantation in the human body or permanent contact with internal bodily fluids or tissues. The Phillips Sumika safety data sheet states that its polypropylene material should not be used in human implants unless it has been provided directly form the company under an agreement which expressly acknowledges such contemplated use.
In addition to being made from these harmful materials, a number of Bard implants are accompanied with specific selling features that can be harmful. For instance, Bard Kugel patches, which were FDA cleared in 2002, have memory coil rings that allow the patch to be folded and inserted through a small abdominal incision and, once in place, they spring open helping the mesh lay flat over the affected area. However, this design has been associated with many problems such as the rings buckling and rupturing. Shrinkage and migration of this mesh is also a common problem that has been reported. Another poorly designed Bard product is their Composix E/X and Composix mesh. This implant consists of two distinct sides, one that is polypropylene (PP) and the other that is ePTFE. This product is associated with a high rate of adhesions for several reasons. One, the heavy weighted PP induces a large inflammatory process that leads to fibrosis. Further, this mesh cannot be cut without widely exposing the PP layer. In addition, the holes in the ePTFE side of the mesh made by the stiches create adhesions. Bard’s Ventralex product, which was also cleared by the FDA in 2002, has similar design problems as described with its Composix products. The heavyweight PP and the ePTFE are mismatched materials because they contract at different rates making them mechanically incompatible. All of these design flaws lead to further complications and often times require the patient to undergo additional surgeries.
Goldman, Scarlato & Penny are investigating the following Bard/Davol mesh products:
If you or a loved one have suffered from pain, infection, organ damage or hernia reoccurrence leading to subsequent surgery you may be entitled to compensation. If you believe you or a loved one may have a claim, contact us today. There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner.
Complete the form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
Melissa Fry Hague
For your FREE CASE REVIEW fill out the below information and we will be in contact with you within the next 24 hours:
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Over the past couple of years Maquet Holding B.V. & Co. and its subsidiary, Atrium Medical Corporation, have come under fire for failing to meet FDA safety standards when it comes to the design and manufacturing of their C-Qur hernia mesh product. Between 2009 and 2013 the FDA conducted ten inspections across three of the Maquet manufacturing facilities. Those inspections uncovered major Quality System, Medical Device Reporting, and Correction and Removal violations that resulted in the FDA halting the manufacturing of C-Qur mesh implants.
The FDA first sent a warning letter to Maquet in 2010, which detailed the identified violations and required that they be corrected to avoid further action. Maquet failed to make the required changes and in 2012, the FDA sent another warning letter to the corporation. In this letter, they detailed the problems with sterilization, complaint follow-up, safety trials and general non-compliance, which were found during their investigations. The FDA sent a final warning letter in December 2014, which again detailed the company’s violations and their obligation to address these issues.
Maquet and Atrium failed to adequately respond to the FDA’s multiple warning letters. This led the FDA to file for a permanent injunction against Atrium Medical in February 2015. A federal judge form the U.S. District Court for the District of New Hampshire agreed with the FDA and entered a consent decree of permanent injunction against Maquet and three of its subsidiaries, including Atrium Medical Corporation, which manufactured and distributed C-Qur hernia mesh.
The consent decree orders that Maquet cease manufacturing and distributing devices from Atrium’s Hudson facility until that facility is in compliance with all regulations. The consent decree bans Maquet from making and selling the following Atrium products:
Although the injunction prevents Maquet from manufacturing and selling these products, unlike a recall it does not require the return of previously sold products and does not prevent healthcare facilities from using product that they already have in stock. For instance, several hospitals, who were able to purchase C-Qur mesh at cheap bulk prices before the injunction was entered, are still implanting this mesh in patient’s today, which is technically not a violation of the injunction order.
Cases against Atrium in connection to injuries allegedly sustained by C-Qur mesh, have been consolidated in a Multi-District Litigation (“MDL”) in the United States District Court of New Hampshire. Click here to visit the Atrium C-Qur Official MDL website and learn more about the status of this litigation.
If you or a loved one have suffered from pain, infection, organ damage or hernia reoccurrence leading to subsequent surgery you may be entitled to compensation. If you believe you or a loved one may have a claim, contact us today. There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner.
Complete the form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
Melissa Fry Hague
For your FREE CASE REVIEW fill out the below information and we will be in contact with you within the next 24 hours:
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