Bard Sepra Technology “ST” Hernia Mesh Lawsuit
Lawsuits are being filed around the United States against Bard and its subsidiary Davol, alleging that their ST polypropylene hernia mesh line is defective. All Bard ST polypropylene hernia meshes were requested to be included in MDL 2846. Bard ST polypropylene hernia meshes include the SepraMesh, Ventralight ST, Ventralex ST, and the Ventrio ST.
The Evolution of Defective Hernia Mesh
In 1996, Surgical Sense, Inc. received 510(k) clearance on the Kugel Hernia Patch, which it claimed was substantially equivalent to Atrium Polypropylene Mesh. The Kugel is a multi-layered hernia mesh patch with a permanent internal ring. Atrium Polypropylene Mesh is a single-layered, flat, hernia mesh. The two meshes are obviously quite different, yet the FDA still allowed Bard to skip the Premarket Approval (PMA) process and instead cleared the Kugel through the unsound 510(k) clearance process by claiming “substantial equivalency.” How Bard’s Ventralex ST came into existence is a prime example of what we call 510(k) creep, which is when a product with a completely new design suddenly is allowed onto the market with absolutely no human test being required by claiming 510(k) substantial equivalency. That’s right, not one human implant is required for a medical device to receive FDA 510(k) clearance and then be on the shelves in every hospital in the United States. Products with new designs are intended to go through the PMA process, which requires human trials, but that takes both time and money…. and who knows if the outcomes will be favorable. The 510(k) clearance process on the other hand is fast, cheap, and a safe bet.
An Evolving Hernia Mesh Market
The hernia mesh market is a multi-billion dollar a year industry. In the early 1990’s the goal of hernia mesh industry was to create hernia meshes which were quicker and easier to implant, so that even an unspecialized surgeon could permanently fix a hernia in minutes. These new hernia meshes would greatly expand the hernia mesh market and the meshes could be sold at several times the price of standard meshes. Whichever company could get to the market first with a fast and effective product would likely go on to dominate the multi-billion dollar hernia mesh market. Surgical Sense, Inc. somehow got FDA 510(k) clearance for the Kugel, which included a permanent ring, intended to allow surgeons to fold the mesh, insert it through a small incision, and let the mesh spring back open. However, there were some problems apparent with the untested Kugel. First, the Kugel was difficult to get to lay flat against the abdominal wall after insertion. Second, the permanent internal ring of the Kugel was fracturing in some patients and perforating internal organs, requiring complex emergent surgery.
Bard Acquires Surgical Sense, Inc. and the Kugel
In 2001, Bard acquired Surgical Sense, Inc. and the Kugel Hernia Patch. Bard then quickly came out with the Modified Kugel, which incorporated polypropylene straps that could be pulled to make it easier to manipulate the Kugel to lay flat against the abdominal wall. Bard also attempted to fix the Kugel’s devastating ring break problem. Bard hoped that the oval shape of the original Kugel was resulting in pressure being distributed unevenly to the permanent internal ring, resulting in the ring breaking. in response, Bard changed the shape of the Kugel from an oval to a circle, so that pressure would be distributed evenly over the entire ring. However, the Modified Kugel was still plagued by the ring break problem, because the polypropylene contracts over time, eventually to a size smaller than the permanent internal ring. Once the polypropylene has significantly shrunk, the permanent internal ring will either buckle and result in a wadded up mesh, or the ring will break. It does not appear that Bard ever applied for or received 510(k) clearance from the FDA for the Modified Kugel (By the way, it’s not illegal to skip the 510(k) process. The FDA has the right to enforcement of FDA related violations, and the FDA can choose to never punish a company, which seems to happen quite frequently). The hernia mesh 510(k) creep continued and Bard quickly began taking over nearly the entire hernia mesh market (During this same time period Bard was also taking over the entire inguinal hernia mesh market with it’s PerFix Plug. Yeah, Bard didn’t initially get 510(k) clearance on that mesh either).
A few more years passed and new complications were starting to pop up with the untested Modified Kugel. The insertion technique of the Kugel and Modified Kugel resulted in the mesh laying closer to the patient’s bowels. As a result, the polypropylene of the Kugel would densely adhere to the patient’s bowels, or even erode through the bowel. In attempt to reduce bowel adhesions, Bard added a layer of expanded polytetrafluoroethylene (ePTFE) to the Kugel to create the Composix Kugel in 2001. The FDA’s website pulls up a page for the Composix Kugel 510(k), but oddly no summary of the 510(k) is available. This new design resulted in a material mismatch; the ePTFE shrinks even faster than the polypropylene. This material mismatch caused the Composix Kugel to fold and contort. Upon reoperation, many surgeons note that the Composix Kugel had “potato chipped.” As the Composix Kugel continued to shrink, the permanent internal ring would eventually give way and break. In 2006, Bard initiated a recall on its prized Composix Kugel, because the “memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula.” However, Bard did not recall the Composix Kugel at this time, nor did Bard fix the underlying problems with the Composix Kugel.
A New Hernia Mesh Market: Resorbable Coatings
During the same time period that Bard was losing it’s market share due to recalls of the Composix Kugel, other hernia mesh manufacturers were taking control of a newly created hernia mesh market: resorbable coated hernia meshes. Two of the first resorbable coated hernia meshes to enter the market included Johnson & Johnson’s Proceed hernia mesh and Atrium’s C-Qur hernia mesh. These new resorbable coated meshes could be sold for many times the price of traditional meshes, and were placed closer to the bowel, enabling less skilled surgeons to now use mesh. It was predicted that the resorbable coated hernia mesh market would soon overtake nearly the entire hernia mesh market. Bard had a couple of problems though. First, Bard hadn’t developed a resorbable coating for its mesh, nor was one in the pipeline. Second, on June 18, 2002 the FDA released the “Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery – Guidance for Industry” which defined resorbable coated meshes as a “significant risk device” that would not be eligible for 510(k) clearance, but would instead need to undergo the extensive safety testing required to receive Premarket Approval.
Bard’s Hernia Mesh Line is Being Assaulted on All Fronts
Bard didn’t have the time to pass the extensive testing needed for FDA Premarket Approval, much less the time to develop a completely new product from scratch. To make matters worse, it wasn’t just the coating that Bard would need to get FDA Premarket Approval for, but the entire newly created hernia mesh, including the polypropylene. Like all other mesh manufacturers, Bard knew they couldn’t legitimately pass the safety testing, because the polypropylene would fail bio-compatibility testing. However, the mesh manufacturers were no longer the only companies that were aware that polypropylene wasn’t fit for human implantation… the company which produced the raw polypropylene had been alerted to this national health crisis.
The Polypropylene Problem
At the same time that Bard is trying to figure out how to enter the resorbable coated hernia mesh market, Chevron Phillips, the manufacturer of Bard’s raw polypropylene known as Marlex, drops a bomb shell on the entire hernia mesh industry. In 2004, Chevron Phillips puts the profits it could make aside and warns all companies that none if its polypropylene is to be used in medical applications involving the permanent implantation in the human body or permanent contact with internal body fluids or tissues. The revelation sent shock waves throughout the entire hernia mesh injury. How were these mesh manufacturers to continue making billions of dollars in the hernia mesh industry if their dirt cheap base material was no longer available?!?
Prohibited Polypropylene: Potential Future Liability vs Current Profits
For very small hernia mesh manufacturers, suddenly the potential legal liability of using prohibited or non-medical grade polypropylene was so great that the smaller mesh manufacturers could no longer justify the profits they were making on hernia mesh. However for a hernia mesh juggernaut like Bard, which derived a substantial portion of its corporate profits off of hernia mesh, the risk of potential legal liability for using prohibited or non-medical grade polypropylene was easily justified by the massive continued profits. Not only did Bard continue to manufacture hernia mesh utilizing polypropylene, Bard took full advantage of the market conditions to finally expand into the resorbable coated hernia mesh market.
Back in 1996, a small biotechnology company known as Genzyme received FDA Premarket Approval on a surgical product known as Seprafilm. Genzyme’s SepraFilm was an absorbable adhesion barrier composed of chemically modified carboxymethylcellulose and sodium hyaluronate also known as hyaluronic acid (HA/CMC). The SepraFilm was intended to be placed in the patients abdomen after a surgical procedure to prevent flimsy adhesions which can naturally occur after any operation. Flimsy adhesions that occur after normal surgical procedures don’t pose nearly the significant risk that dense adhesions do, which form in the presence of polypropylene and other permanent meshes. Genzyme’s SepraFilm does not contain any polypropylene, it turns to a gel within 24-48 hours of implantation, and it resorbs from the abdomen within 7 days. The SepraFilm both resembles and feels like a large Listerine strip.
Sepramesh Contains Two Types of Acid
Next, Genzyme utilized polylactic acid (PLA) and polyglycolic acid (PGA) fibers to adhere the Seprafilm to a polypropylene mesh creating the Sepramesh Biosurgical Composite (Sepramesh). Genzyme then received FDA 510(k) clearance for the Sepramesh on March 2, 2000 (2 years before the FDA declared resorbable adhesion barriers a significant risk device requiring Premarket Approval). Genzyme unexpectedly didn’t list its Seprafilm as a predicate device in the Sepramesh 510(k) application. Genzyme claimed that the HA/CMC coating (Seprafilm portion) would be resorbed in 5-7 days. The following are the only listed predicate devices for the Sepramesh:
- Bard Mesh (an uncoated, heavy-weight mesh, which is rarely utilized today)
- Bard Composix Mesh (polypropylene and ePTFE mesh, no longer in production)
- Ethicon Mersilene Mesh (polyester mesh, no longer in production)
Genzyme Conceals From the FDA that the Sepramesh Contains Acid
In the device description of the Sepramesh 510(k) application, Genzyme only listed polypropylene, sodium hyalurnate, and carboxymethylcellulose as components as of the Sepramesh. Genzyme failed to disclose the to FDA in its 510(k) application that the Sepramesh also included large amounts PLA and PGA, both of which are highly acidic substances and were intended to be resorbed! Lowering the pH of the abdominal cavity is just asking for an infection and other complications! Genzyme likely feared that if the FDA would require Premarket Approval if they realized that the Sepramesh included PLA and PGA. Genzyme didn’t even define what PLA and PGA was in its 510(k) application to the FDA! Additionally, Genzyme didn’t disclose to the FDA that the PLA and PGA would take at least 6 to 8 months to fully breakdown and resorb. Material breakdown and resorption significantly increases inflammation, which increases the risk of infection, polypropylene degradation, and other complications. The hidden PLA and PGA in the Sepramesh substantially increases inflammation for over half a year at the site of implantation.
Sepramesh Fails to Gain a Market Foothold
Even after Genzyme gained 510(k) clearance for the Sepramesh, few surgeons ever started using it. Most surgeons never started implanting the Sepramesh, because it had never been tested in humans and there was a lingering suspicion that it would raise infection rates. When Chevron Phillips banned the use of its Marlex polypropylene to be implanted in humans, the potential liability started to outweigh the profits that Genzyme was making off of the Sepramesh. Luckily, Genzyme didn’t incur much of an expense at all in securing FDA 510(k) clearance on the Sepramesh. In 2018, it still cost less than $10,000 to have the FDA review a device and grant 510(k) clearance! For less than $10,000 and without ever conducting one human trial, Genzyme was able to get a product onto the market which the FDA itself classified as a “substantial risk!”
A Match Made in Hell
Even though the Sepramesh wasn’t bringing in big profits for Genzyme, there was still something that made the Sepramesh potentially very valuable; the Sepramesh was one of a few hernia meshes with a resorbable coating that had received FDA 510(k) clearance before the FDA issued its 2002 Guidance for Resorbable Adhesion Barrier Devices, which advocated for Premarket Approval. Now that Genzyme wanted to get rid of the Sepramesh liability, it just needed to find the perfect buyer. A buyer that both needed a resorbable coated hernia mesh and was going to keep selling hernia meshes regardless of the status of the polypropylene. Bard was that perfect buyer for the intellectual property (IP) rights to Sepramesh, but Genzyme had even more in mind. Genzyme had just found a potential loophole that would allow it to both increase its profits from the Sepramesh and simultaneously substantially reduce its potential liability.
The Biomaterial Suppliers Loophole
Genzyme knew that Bard desperately needed a resorbable coated hernia mesh. Genzyme also knew that once Bard started selling the Sepramesh, it could potentially grow into a highly profitable hernia mesh. Instead of selling the IP rights of the Sepramesh to Bard, Genzyme offered to allow Bard to buy a license to utilize the Sepramesh and the coating of the Sepramesh. In December of 2007, Bard entered into a license agreement with Genzyme to manufacture and market the Sepramesh IP hernia repair product line and to incorporate the related Sepra Technology (ST) coating into future hernia repair meshes. Genzyme retained all rights to the Seprafilm itself. Now that Genzyme wasn’t selling the Sepramesh itself, Genzyme could potentially be immune from liability related to injuries caused by the Sepramesh. 21 U.S. Code §1604 – Liability of Biomaterial Suppliers states that “a biomaterials supplier shall not be liable for harm to a claimant caused by an implant.” There are some narrow exceptions, all of which Genzyme likely falls outside of.
Bard also had difficultly getting the untested Sepramesh to gain popularity among surgeons. In July of 2010, Bard received FDA 510(k) clearance for the Ventralight ST Mesh. In the 510(k) application, Bard claimed the coating “becomes a hydrated gel that is resorbed from the site in less than 30 days (Genzyme previously claimed the Sepramesh coating was resorbed within 5-7 days).
To create the Ventralight ST, Bard utilized a lighter weight polypropylene (decreased the polypropylene filament diameter by .001 in) than was used in the Sepramesh. To fill in the extra space created by decreasing the polypropylene filament diameter, Bard increased the amount of PGA. Increasing the amount of PGA resulted in the Ventralight ST Mesh being even more acidic and inciting a greater inflammatory response than the Sepramesh. However, surgeons were eager to try a hernia mesh which utilized light-weight polypropylene. The Ventralight ST finally started to increase Bard’s resorbable coated hernia mesh market share. As with most hernia meshes with resorbable coatings, latent infections, seromas, and fistulas also became associated with the Ventralight ST. As more time passed, it also became evident that the Ventralight ST was ineffective at preventing adhesion, which get denser and solidify over time. Many Ventralight ST patients have required additional surgeries years later due to bowel obstructions after dense adhesions formed between the bowel and Ventralight ST. The degree to which the Ventralight ST bonds to the bowel frequently necessitates the surgeon removing a portion of the patient’s bowel, resulting in extended hospitalizations and life-changing complications.
Bard then further expanded the ST product line by applying the ST coating to its Ventralex patch. The FDA granted Bard 510(k) clearance for then Ventralex ST on March 23, 2011. In the 510(k) application, Bard described the Ventralex ST Hernia Patch as being composed of a top layer of polypropylene (0.004″ monofilament) and a bottom layer of Sepramesh. The Sepramesh layer (which also contains polypropylene) is stitched to the polypropylene layer with polytetrafluoroethylene (PTFE). Instead of placing a permanent memory ring within the polypropylene and Sepramesh layers, Bard utilized “Sorbaflex Memory Technology.” The Sorbaflex Memory Technology is composed of an extruded polydioxanone (PDO) absorbable polymer monofilament that is contained within a knitted polypropylene mesh tube. Bard noted the absorption of Sorbaflex PDO monofilament “is essentially complete in 6 to 8 months” by means of hydrolysis. Polymers are broken down into monomers in a process known as hydrolysis, which means “to split water,” a reaction in which a water molecule (which contains oxygen) is used during the breakdown. Hydrolysis results in increased oxidation, the process by which polypropylene is degraded.
Bard submitted the Ventrio ST 510(k) on the same day it applied for the Ventralex ST 510(k), and the FDA cleared both Ventrio ST and Ventralex ST 510(k) on the same day. The Ventrio ST is an oval like the original Kugel, while the Ventralex ST is circular like the Modified Kugel. The Ventrio ST lacks the polypropylene positioning straps that are included on the Ventralex ST, which are intended to facilitate placement of the small patch through a trocar. Bard’s 510(k) applications for both the Ventralex ST and Ventrio ST disclose that the Sepramesh portion contains both PGA and HA, but neither disclose the presence of PLA, another acidic polymer that Genzyme also tried to hide in its initial 510(k) application. These highly acidic polymers with long resorption times are resulting it life-threatening infections, fistulas, and dense adhesions resulting in bowel obstructions and bowel resections. Bard has yet to issue a single recall on its ST hernia mesh line and continues to aggressively market the ST line to surgeons around the United States. Recently, Bard began applying its ST coating to a fully resorbable polymer instead of polypropylene, and currently sells the mesh under the name Phasix ST.
Bard ST Hernia Mesh Lawsuit
Call 1-800-701-3672 today if you have been injured by a Bard ST hernia mesh. The Hollis Law Firm is reviewing claims related to all types of Bard ST polypropylene hernia mesh, including the light-weight version Ventralight ST. All consultations and legal work are on a contingent fee basis, which means the consultation is free and we only get paid if you receive compensation. Call 1-800-701-3672 now for a free, no obligation, Bard ST hernia mesh case evaluation. The Hollis Law Firm continues to file Bard ST hernia mesh lawsuits around the United States.
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