Marlex Hernia Mesh Devices by C.R. Bard

Q: What is Marlex?

Marlex is a trademark name for solid HGX-030-01 polypropylene. This chemical is a type of plastic that is used in a variety of things from Hula Hoops to plastic bottles. Marlex is made using ethylene and propylene with a catalyst of chromium oxide. It was first created in the 1950s by workers at the Phillips Petroleum Company – now the Chevron Phillips Chemical Company. What sets Marlex plastic apart from other plastics is the density it can achieve from relatively little pressure. Most other plastics take thousands of pounds of pressure to squeeze them into soft shapes. Marlex plastic only takes a few hundred pounds of pressure to squeeze it into a rigid shape.

Q: How Marlex came to be used in hernia mesh

C.R. Bard started using Marlex polypropylene in its mesh products in the 1970s. While Marlex was mainly used in the company's vaginal mesh implants, it was also used in its hernia mesh devices, as well. This was before the U.S. Food and Drug Administration (FDA) began regulating medical devices in 1976. Because hernia meshes made from Marlex plastic were on the market before 1976, they were “grandfathered” into approval. The regulations that gave the FDA power over medical devices also included an important loophole: Medical devices made in the future that were “substantially similar” to pre-1976 devices got an expedited approval known as the 510(k) clearance process. Because hernia meshes made of Marlex were already on the market in 1976, any hernia mesh based on the Marlex model could hit the market quicker through the 510(k) clearance process.

Q: How are Bard's Marlex meshes defective?

Marlex is a plastic that oxidizes, or deteriorates when it comes into contact with oxygen. Once implanted in a person, a hernia mesh made from Marlex gets surrounded by tissues and blood that contain oxygen. Even when the Marlex is treated with antioxidant additives that slow the oxidization process down, those additives eventually dissipate. In the end, the Marlex is left unprotected and begins to erode slowly.

Marlex is the trademarked name for a specific type of plastic. That plastic is used in many of C.R. Bard’s hernia mesh products. Marlex was never being designed for internal use, as it was known to degrade inside the body as it comes into contact with oxygen. Nevertheless, C.R. Bard has used Marlex in its hernia mesh products since the 1970s. The disintegration of Marlex inside the body has been a centerpiece of hernia mesh lawsuits filed by victims who have been hurt by their implants.

Marlex is a non-biologic, high-density polyethylene with great tensile strength

1. What is Marlex?

Marlex is a trademark name for solid HGX-030-01 polypropylene. This chemical is a type of plastic that is used in a variety of things from Hula Hoops to plastic bottles. Marlex is a synthetic material made using ethylene and propylene with a catalyst of chromium oxide. It was first created in the 1950s by workers at the Phillips Petroleum Company – now the Chevron Phillips Chemical Company.

What sets Marlex plastic apart from other plastics is the density it can achieve from relatively little pressure. Most other plastics take thousands of pounds of pressure to squeeze them into soft shapes. Marlex plastic only takes a few hundred pounds of pressure to squeeze it into a rigid shape.

2. How Marlex came to be used in hernia mesh

C.R. Bard started using Marlex polypropylene in its healthcare mesh products in the 1970s. The use of Marlex monofilament polypropylene mesh was mainly for the company’s vaginal mesh implants, it was also used in its hernia mesh devices, as well (such as for inguinal hernia repair and ventral hernia repair). This was before the U.S. Food and Drug Administration (FDA) began regulating medical devices in 1976. Because hernia repair meshes made from Marlex plastic were on the market before 1976, they were “grandfathered” into approval.

The regulations that gave the FDA power over medical devices also included an important loophole: Medical devices made in the future that were “substantially similar” to pre-1976 devices got an expedited approval known as the 510(k) clearance process. Because hernia meshes made of Marlex were already on the market in 1976, any hernia synthetic mesh based on the Marlex model could hit the market quicker through the 510(k) clearance process.

3. How Bard’s Marlex meshes are defective

Marlex is a plastic that oxidizes, or deteriorates when it comes into contact with oxygen. Once implanted in a person following laparoscopic incisional hernia surgery, a plastic mesh made from Marlex gets surrounded by tissues and blood that contain oxygen. Even when the Marlex is treated with antioxidant additives that slow the oxidization process down, those additives eventually dissipate. In the end, the Marlex is left unprotected and begins to erode slowly.

These chemical traits of Marlex are well known.

In 2005, the makers of Marlex, Chevron Phillips, learned that medical device manufacturer Boston Scientific was shaping Marlex polypropylene into tightly-woven mesh devices for implantation, and that they were making huge profits on it. Shocked that their material was being used for implants that it was never designed for, Chevron Phillips refused to sell Marlex to Boston Scientific at any price.¹

Chevron Phillips’ refusal to sell Marlex for use in implantable hernia meshes put Boston Scientific in a tough spot: They had to use something “substantially similar” to Marlex to benefit from the expedited 510(k) clearance process, but Marlex suppliers were freezing them from the market to avoid liability for using something so dangerous in a medical implant.² After numerous failed attempts that brought Boston Scientific to the end of its stockpile of Marlex, the company bought a suspect load of counterfeit Marlex from Chinese suppliers.³ It smuggled the counterfeit materials out of China to the U.S. through Belgium “like a drug deal.”⁴

Despite internal testing that indicated the plastic material was probably not actually Marlex, and that it definitely had lower levels of antioxidant materials in it, Boston Scientific began using it to make implantable mesh devices, anyway.⁵

Lawsuits against Boston Scientific claim that the new material has been used in its mesh products since at least 2014.⁶

Chemical experts have estimated that the mesh devices using this new material, which are designed for life-long implantation, would likely begin to oxidize and deteriorate within a few months.⁷

Many patients with Marlex mesh have endured devastating injuries.

4. Bard’s hernia mesh products that use Marlex

C.R. Bard has utilized the 510(k) clearance process to speed many of its mesh implants into hospitals. There, surgeons continue to use them without worrying about the long-term effects.

While many of Bard’s implants that use Marlex are for transvaginal procedures, several of the company’s hernia mesh devices are made of HGX-030-01 polypropylene, as well. These include the following hernia mesh models and product numbers:

Model	Product Number
Bard Mesh (sometimes referred to as “Marlex Mesh” or “Bard Flat Mesh” by medical professionals)	0112640 0112650 0112660 0112670 0112680 0112720
Bard Mesh Perfix Plug	0112750 0112760 0112770 0112780 0112950 0112960 0112970 0112980
VentralexST	5950007 5950008 5950009
Sepramesh IP Composite	5959124 5959360 5959480 5959680 5959812
3DMax	0115310 0115311 0115312 0115320 0115321 0115322

5. FDA intervention

While the FDA has not recalled mesh products made from Marlex, they have ordered manufacturers of certain mesh products to stop selling their products in the U.S.⁸ While this order only impacts implantable mesh products that are used for the transvaginal repair of pelvic organ prolapsed, rather than the entire line of mesh products that use Marlex polypropylene, the order is a move in the right direction.

6. Injuries caused by Marlex hernia mesh

Hernia mesh implants that are made of HGX-030-01 polypropylene can cause severe injuries and side effects. They include:

All of these injuries are the results of the erosion of the Marlex plastic that makes up the mesh implant. As HGX-030-01 polypropylene oxidizes, it shrinks and unravels. Because the mesh implant is designed to irritate the abdominal wall to create scar tissue that grows into the mesh’s pores, that shrinkage pulls on the tissues that the mesh has grown into. If nerve endings have grown into the mesh material, this internal tugging can cause chronic pain.

When hernia mesh implants made from Marlex plastic erodes and shrinks, it can also peel away from the abdominal wall. If it becomes completely undetached, it can migrate elsewhere in the body and cause problems wherever it goes.

Eroding Marlex implants can also cause severe medical problems if they compromise internal organs. While hernia mesh implants are supposed to adhere to the abdominal wall to strengthen it and prevent further hernias, they can also stick to other organs or tissues. If the implant adheres to the intestine, it can create a bowel obstruction. This can be a life-threatening medical issue if not diagnosed and treated quickly.

Infections are also common injuries suffered by people who have had Marlex mesh implanted to repair a hernia. Marlex is a very porous type of plastic. While the pores make Marlex lightweight and good for hernia mesh, it provides breeding grounds for bacteria. If the implant is not sterile before the procedure, or if it is compromised during or after it, patients can suffer severe infections.

7. Potential medical complications of defective Marlex mesh

The side effects of Marlex hernia mesh can also trigger further medical complications, including:

Recurrent hernias,
Internal bleeding, and
Perforated tissues and organs.

As the Marlex mesh erodes and shrinks, it can leave the implant site. When the mesh migrates like this from the surgical site, it can peel away from the abdominal wall and cause internal bleeding. It also strips tissue from the abdominal muscles that prevent hernias from happening. When Marlex mesh migrates, it is often a precursor to a recurrent hernia; without the mesh’s support and the abdominal tissue, patients are far more likely to experience a recurrent hernia.

Migrating Marlex mesh can even perforate the tissues and organs it has adhered to, when it erodes and pulls away. This is a serious medical complication, if the mesh has stuck to the abdominal wall. When it adheres to an organ like the intestines, perforation can become a life-threatening complication. Surgeons may need to perform a bowel resection.

8. Current lawsuits over Marlex hernia mesh

There are hundreds of lawsuits against C.R. Bard over their hernia mesh products and high incidence of complications. These lawsuits include claims against Bard for their hernia mesh products that rely on Marlex or HGX-030-01 polypropylene.

In federal court, around 2,500 of these lawsuits are currently pending in the Southern District of Ohio in a multidistrict litigation (MDL).⁹ These claims are presided over by Judge Edmund A. Sargus, Jr.

There are also thousands of state law claims against Bard currently pending in Rhode Island.^¹⁰

In addition to these lawsuits, there are also several against C.R. Bard over their Marlex-based transvaginal mesh implants.¹¹ These transvaginal mesh lawsuits are similar to the claims against Bard for their hernia mesh implants – the scientific findings about the effects of HGX-030-01 polypropylene on the human body are going to be relevant to both claims. However, the injuries suffered by plaintiffs in the two types of lawsuits are going to be different.

Attorneys are trying to recovery money for plaintiff’s pain and suffering, lost wages, and medical bills, which includes hospital stays, follow-up visits, home health care, medications, and more.

Our law firm represents clients throughout the United States.

See our related articles on Ethicon lawsuits and Atrium lawsuits.

References:

See Scott Pelley, “Gynecological Mesh: The Medical Device that has 100,000 Women Suing,” CBS News (April 17, 2019). See also Howard Patt, MD, Marlex Mesh Grafts in Inguinal Hernia Repair, Arch Surg (May 1967). See also Francis Usher, MD, et al., Marlex Mesh, a New Plastic Mesh for Replacing Tissue Defects, AMA Arch Surg. (January 1959). See also Usher Francis C., Gannon J.P., Marlex Mesh: A New Plastic Mesh for Replacing Tissue Defects. I. Experimental Studies. AMA. Arch. Surg (1959).
See note 1.
See note 1.
Stevens v. Boston Scientific Corp., No. 2:16-0265 (S.D. W.V. Jan. 12, 2016) (complaint) (claiming racketeering violations for Boston Scientific’s vaginal mesh implants).
See note 1.
Hennington v. Boston Scientific Corp., No 2:16-cv-06321 (E.D. N.Y. Nov. 14, 2016) (complaint) (class action claiming racketeering violations for Boston Scientific’s vaginal mesh implants).
See note 1.
FDA News Release, “FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices,” (April 16, 2019).
In re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, MDL 2846 (S.D. Ohio).
In re: Davol/C.R. Bard Hernia Mesh Multi-Case Management, No. PC-2018-9999.
See e.g., notes 4 and 6; also see T Liakakos, I Karanikas, H Panagiotidis, S Dendrinos, Use of Marlex mesh in the repair of recurrent incisional hernia, 1994 Feb;81(2):248-9; doi: 10.1002/bjs.1800810230, Pubmed.

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Marlex Hernia Mesh Devices by C.R. Bard – Key Information