Does Polypropylene (Plastic) in Hernia Mesh Degrade After Implanting in Humans?

Polypropylene hernia mesh, once hailed as a medical innovation, has unfortunately caused significant harm to many patients. When this plastic material degrades within the body, it can lead to severe complications such as chronic pain, infection, and even organ damage. If you or a loved one has been affected by polypropylene hernia mesh degradation, seeking legal assistance is crucial. Hollis Law Firm specializes in such cases and can offer the support and expertise needed to navigate this challenging situation.

If you or a loved one has been harmed by polypropylene hernia mesh degradation, don’t wait to seek help. Contact Hollis Law Firm today for a free consultation. Our experienced attorneys are dedicated to fighting for your rights and securing the compensation you need to move forward. Let Hollis Law Firm provide the expertise and support you need during this challenging time.

Does Polypropylene (Plastic) in Hernia Mesh Degrade After Implanting in Humans?

For over five decades, hernia mesh manufacturers have claimed that the polypropylene (PP) utilized to make their hernia mesh products is inert. An inert object will not change or degrade over time. Hernia mesh implants are life-long medical devices; therefore, it is of the utmost importance that the material utilized to make the hernia mesh is inert.

Polypropylene is known to degrade through a process called oxidation. It was initially believed that polypropylene would not oxidize enough after implantation to undergo any degradation. Before implantation, it has been well accepted that polypropylene can be oxidized by exposing the polypropylene to gamma irradiation. Therefore, most polypropylene hernia meshes undergo sterilization with ethylene oxide instead of gamma irradiation to prevent the oxidation and degradation process. However, the Proceed hernia mesh continues to utilize gamma irradiation to sterilize the polypropylene, which causes the Proceed mesh to degrade even before implantation.

There is now a growing body of scientific research and literature demonstrating that the polypropylene utilized in hernia mesh implants does oxidize and degrade after implantation. The life-long inflammatory process that polypropylene incites results in oxidization and degradation of the polypropylene. The inflammatory, oxidation, and degradation processes are even more pronounced in coated hernia meshes placed closer to the bowel.

Scientific Articles on Polypropylene Degradation After Implantation

Sept 2017: In Vitro Study on the Deterioration of Polypropylene Hernia Repair Meshes.

The authors conducted the study in order to gain a better understanding of the mechanism of polypropylene mesh deterioration. In doing so, they “developed in vitro methodology, which mimics the oxidative environment at the tissue-implant interface after surgery.” Below are some of the study’s most significant findings.

“It was shown that structural changes in polypropylene meshes exposed to oxidative stress may involve the formation of cross-links between the polymer chains, chain scissions, and hydrogen bonds between the carboxyl groups, which are formed in the material during the oxidation. These effects result in mesh stiffening, ultimately leading to chronic post-operative pain.”

“A growing body of evidence points to oxidative stress as a key factor in the development of the complications associated with post-hernioplasty chronic pain. When exposed to a myriad of oxidants and enzymes after the implantation, hernia repair meshes may undergo various structural, chemical, and mechanical changes. This can cause alterations in the mesh’s linear dimensions. It was shown that mesh shrinkage or expansion is associated with the development of chronic pain and an increased chance of recurrent hernia. Moreover, mesh stiffening can lead to mechanical irritation of the surrounding tissues, thus provoking further excessive immune response.”

Feb 2016: Materials Characterization of Explanted Polypropylene Hernia Mesh: Patient Factor Correlation.

30 polypropylene hernia mesh explants were obtained from the Columbia, MO University Hospital Department of Surgery’s hernia mesh explant repository. The 30 polypropylene mesh explants were removed because of pain, discomfort, and/or hernia recurrence that may cause the mesh to be a potential source of further complications. The implant duration ranged from 9 to 181 months. The authors found that “these results indicate in vivo degradation of PP hernia mesh… More importantly, these measurements indicate the degree of material transformation in vivo, which is important for understanding the biocompatibility and durability of an implant. For instance, a material exhibiting high levels of surface oxidation is likely to exhibit embrittlement and surface cracking resulting in a decrease in material compliance and an increase in the surface area exposed to oxidative degradation, respectively. Enlarged surface areas due to surface cracking may intensify the inflammatory response. [Modulated differential scanning calorimetry] and [thermogravimetric analysis] measurements indicate the changes in the bulk material due to chain scission and/or crosslinking. These changes in bulk material properties can also lead to alteration of mesh compliance as well as variation in mechanical strength and degradation resistance. Reduction in the compliance of material could induce pain due to mesh rigidity during patient movement.”

The authors conclude that “the lack of correlation between the other patient factors and characterization techniques could suggest that PP mesh is extremely susceptible to oxidation regardless of the patient population, but it also suggests the need for continued analysis of explanted hernia mesh.”

Aug 2015: Degradation of Polypropylene in vivo: A Microscopic Analysis of Meshes Explanted From Patients.

164 explanted hernia meshes were examined using conventional microscopy and transmission electron microscopy. Below are the most significant photos and findings of the study.

“It is important to know the effect of degradation of an implanted material on the body and on the long-term performance of the device. When physical and chemical characteristics of a material undergo changes in the body, its applications should include planning for safe and complete removal with minimal tissue damage. This exit-strategy is especially important in younger patients, proximity to organs and large vessels, and anatomical sites which are difficult to reach.”

“Another clinically important aspect of degradation is the potential for bacterial colonization of the fissures within the degraded material. It is known that irregularities of polymer surface promote bacterial adherence.”

“polypropylene degradation was observed across a large range of devices, produced by different manufacturers, explanted from different anatomical locations and due to different clinical complications.”

“For descriptive purposes, the uniform circumferential nature, fissuring and partial peeling of the layer resembled tree bark.”

“Myeloperoxidase is an oxidative enzyme expressed by the inflammatory cells together with an array of other oxidative substances… [Myeloperoxidase] was detected deposited on the surface of the “bark” but was not observed mixed within it. This finding further indicated incompatibility of the “bark” material with water-soluble proteins. It also indicated an oxidative environment immediately around the fibers.”

“polypropylene degradation is likely mediated by the foreign body reaction, which is ongoing until the device is removed. Our observations of adherent macrophages on the polypropylene surface are consistent with the previous studies reporting chronic inflammation in explanted polypropylene mesh several years after implantation. We observed strong staining for the oxidative enzyme myeloperoxidase produced by the macrophages in the tissue surrounding the mesh fibers. This indicated that the surface of the polypropylene was exposed to reactive oxygen species (ROS) while oxidation of polypropylene as a result of the foreign body reaction has been suggested as the mechanism of degradation by earlier reports.”

“There was a good correlation between the thickness of the degradation layer and the duration of in vivo exposure, indicating that the thickness of degraded material grows while the mesh is in the body.”

“Degradation-related stiffening of the mesh is expected to increase over time.”

“A described effect of degradation and wear of medical devices is the release of material particles. The debris from prosthetic joints is well known to cause tissue necrosis, inflammation, and fibrosis around the joints. For polypropylene meshes, we observed occasional particles of degraded polypropylene in the surrounding tissue and macrophages.”

“The fact that the “bark” was melted during excision surgery indicated that the degradation layer was formed in the body before the excision surgery. The finding also revealed that the fiber core and the outer “bark” are composed of materials with similar chemical compositions that are miscible with each other when heated.”

“The [blue] granules were seen in the non-degraded core of the fibers as well as to a variable degree in the outer degradation layer. In the latter, they were detected within the “bark” remaining on the core as well as in the segments on the “bark” separated from the core… which suggests that they also undergo degradation and lose color. The finding was a direct confirmation that the “bark” originated from the same material as the core of the fibers.”

The authors concluded by stating, “We have shown that a focused examination of explanted specimens can reveal features which have been overlooked for decades. Specifically, polypropylene degradation can be detected by readily available conventional light microscopy. A number of features indicated that polypropylene degrades while in the body. Both physical and chemical aspects of polypropylene degradation need to be studied more extensively for their roles in the development of these complications.”

July 2012: Post-Implantation Alterations of Polypropylene in the Human

The study concisely summarizes the degradation process of polypropylene, “Immediately upon insertion an acute inflammatory reaction begins. Neutrophils are the first cells to arrive. They begin to produce oxidants, including hydrogen peroxide and hypochlorous acid, which continue the heat induced oxidative process begun during manufacture. In the environment of the human body, polymers undergo varying degrees of degradation. Oxidation of the PP chains produces free radicals, which cause various events, including depolymerization (breakdown of the molecular chain), cross-linking, oxidative degradation, additive leaching (which may include toxic substances), hydrolysis, and stress cracking. This process produces more free radicals, which perpetuate the chain reaction. Enzyme catalysts allow these reactions to occur at body temperature. Ultimately, due to the breakdown of the structural integrity of the PP polymer chains, the mesh shows signs of surface alterations initially and then deep cracking of the fibers. The end result is lessened structural integrity with changes in molecular weight and crystallinity. The mechanical integrity of the implanted mesh is also decreased.”

The authors of the study conclude that “based on the available evidence, it is clear that [polypropylene] alters in vivo after implantation. It undergoes various processes that lead to degradation, including oxidation, cross-linking, depolymerization, and embrittlement. These processes result in various degrees of degradation and the loss of mechanical and physical properties [polypropylene] is not inert.”

June 2010: Materials Characterization of Explanted Polypropylene, Polyethylene Terephthalate, and Expanded Polytetrafluoroethylene Composites: Spectral and Thermal Analysis.

The authors of the study note that “despite all the improvements to hernia repair in terms of the surgical approach, many complications still exist of which a large subset can be attributed to a lack of material inertness in vivo.” The authors conclude that “[polypropylene] and ePTFE underwent oxidation and crosslinking, respectively. Collectively, the results of these experiments provide evidence of in vivo degradation of the [polypropylene], PET, and ePTFE composites… Identification of in vivo degradation processes might stimulate the design of more inert hernia mesh materials and reduce the need for revision surgeries stemming from material incompatibility.”

February 2007: Materials Characterization of Explanted Polypropylene Hernia Meshes.

The authors note many complications associated with polypropylene hernia meshes and note that the “prolonged inflammatory response is thought to cause fibrosis and a rigid scar plate to form around the mesh material, particularly in the case of polypropylene meshes, leading to chronic pain and reduced mobility. As a result of this chronic inflammatory response, the mesh material is exposed to a continuous bath of oxidants. Aliphatic hydrocarbons such as polypropylene are known to be highly susceptible to oxidative attack… Continuous exposure of polypropylene to these oxidants may lead to chain scission, production of free radicals, and overall degradation of the material, both physically and chemically. This degradation is evidenced by fissures and micro-cracks, with a build-up of hydroxyl and carbonyl groups on the surface of the material, changes in thermal properties such as decreased glass transition and melting temperatures, weight loss, and changes in mechanical properties such as embrittlement and reduced compliance.”

13 explanted polypropylene hernia meshes were examined. Nearly all explanted polypropylene meshes had a decrease in compliance, ranging from 4 to nearly 30 times less compliance. The authors concluded that “the explanted polypropylene meshes did undergo degradation while in vivo, most likely due to oxidation.”

When Can You File a Lawsuit Against Polypropylene Mesh

Hernia surgical mesh implants, often made from materials like polypropylene, are designed to strengthen tissues and prevent hernia recurrence. However, many patients have experienced serious complications due to the degradation and malfunction of these implants. If you’ve suffered harm from polypropylene hernia mesh, you may be eligible to file a lawsuit. Here are the criteria you should consider:

Medical Diagnosis and Complications

Before pursuing legal action, it’s crucial to have a clear medical diagnosis of the complications you’re experiencing due to the hernia mesh. These complications can include chronic pain, infection, bowel obstruction, mesh migration, adhesion to organs, or other severe health issues. Documenting these complications with medical records and reports is essential to support your case.

Evidence of Product Defect or Negligence

To file a successful lawsuit, you must demonstrate that the polypropylene hernia mesh was defective or that its manufacturer was negligent in designing, manufacturing, or marketing the product. This can involve proving that the mesh was unreasonably dangerous, prone to degradation, or failed to perform as intended. Evidence may include medical studies, expert opinions, product recalls, or internal company documents showing knowledge of potential risks.

Causation Between Mesh and Harm

You must establish a clear causal link between the polypropylene hernia mesh and the harm you’ve suffered. This requires showing that the complications you’re experiencing are directly attributable to the mesh implantation. Medical experts can play a crucial role in linking your symptoms to the specific characteristics or defects of the hernia mesh.

Statute of Limitations Compliance

Each state has a statute of limitations, which is the time limit within which you must file a lawsuit after discovering the harm caused by the hernia mesh. It’s essential to adhere to this deadline to preserve your legal rights. Consulting with an attorney promptly after experiencing complications is advisable to ensure you meet all legal deadlines.

If you believe you’ve suffered harm due to polypropylene hernia mesh, Hollis Law Firm is here to help. Our experienced attorneys specialize in defective medical device cases and can provide the expertise and support you need to seek justice and compensation. Contact us today for a free consultation to discuss your potential case and learn more about your legal options.

Understanding Polypropylene in Hernia Mesh Degradation

Polypropylene, a type of plastic used in many hernia mesh products, has been linked to various complications when it degrades within the body. Patients who have suffered from these complications may experience severe pain, infection, or other serious health issues. If you or a loved one has been harmed by polypropylene hernia mesh degradation, Hollis Law Firm is here to help. Our experienced attorneys specialize in defective medical device cases and can guide you through the complex legal process to seek justice and compensation.

The Issue With Polypropylene Hernia Mesh

Polypropylene is a synthetic plastic polymer that has been widely used in medical devices, including hernia mesh implants, due to its strength and durability. However, when used in the body, polypropylene can degrade over time, leading to serious complications. These complications can include:

• Chronic Pain: As the mesh degrades, it can cause inflammation and pain in the surrounding tissues.
• Infection: Degraded polypropylene can create an environment conducive to bacterial growth, leading to severe infections.
• Mesh Migration: The mesh can move from its original placement, causing damage to nearby organs and tissues.
• Adhesion: Scar tissue can form around the degrading mesh, leading to adhesions that cause further pain and complications.

If you have been harmed by polypropylene hernia mesh degradation, Hollis Law Firm is here to help you seek justice and compensation.

Why You Need Legal Help

Navigating the legal landscape of a medical device lawsuit can be overwhelming, especially when dealing with the physical and emotional toll of medical complications. Hollis Law Firm understands the challenges you face and is dedicated to providing the support and expertise needed to pursue your case effectively. Here’s how we can help:

Expertise in Medical Device Litigation

Hollis Law Firm has a proven track record of handling complex medical device litigation cases, including those involving polypropylene hernia mesh. Our attorneys are well-versed in the intricacies of these cases and stay updated on the latest developments and research related to hernia mesh complications. This expertise allows us to build a strong case on your behalf, increasing your chances of a successful outcome.

Comprehensive Case Evaluation

We begin by conducting a thorough evaluation of your case to determine the extent of the harm caused by the polypropylene hernia mesh. This includes reviewing your medical records, consulting with medical experts, and gathering evidence to support your claim. Our goal is to understand the full impact of the complications on your health and quality of life.

Aggressive Representation

Hollis Law Firm is committed to fighting for your rights and holding the responsible parties accountable. We will aggressively pursue your case, whether through negotiation for a fair settlement or by taking the case to trial if necessary. Our attorneys are skilled negotiators and litigators who will work tirelessly to secure the compensation you deserve.

Support Throughout the Legal Process

Dealing with a legal case while managing your health can be stressful. Hollis Law Firm is here to provide support and guidance every step of the way. We will keep you informed about the progress of your case, answer your questions, and provide the reassurance you need during this challenging time. Our compassionate approach ensures that you are not alone in this fight.

Been Hurt by a Defective Medical Product? Contact Hollis Law Firm Today

Experiencing complications from polypropylene hernia mesh degradation can be devastating, affecting your health, well-being, and quality of life. Understanding your legal options and knowing when to pursue a lawsuit is crucial to seeking justice and obtaining the compensation you deserve. The process can be complex, but with the right legal representation, you can navigate it successfully and hold the responsible parties accountable.

If you or a loved one has been harmed by polypropylene hernia mesh degradation, don’t wait to seek help. Contact Hollis Law Firm today for a free consultation. Our experienced attorneys are dedicated to fighting for your rights and securing the compensation you need to move forward. Call us at (800) 701-3672 or fill out our contact form. Let Hollis Law Firm provide the expertise and support you need during this challenging time.