Hernia mesh products come in many sizes, shapes, and types. They have been used by millions over the years for hernia repairs. Their use is preferred by doctors because they are supposed to reduce chances of hernia recurrence. They are, however, the cause of serious complications and injuries, including hernia recurrence. Often the severity of the complication is dependent on the type of product, what it's made of, and what it does.
If you have had a hernia mesh implant and suffered injuries, then you may want to know what type of implant was used and what it was made of. We try to answer some of those questions here.
- 1. What is surgical mesh?
- 2. What are the different types of hernia mesh products?
- 3. What are hernia mesh products made of?
- 3.1 What is synthetic mesh?
- 3.2 What is animal-derived mesh?
- 3.3 What is coated or composite hernia mesh?
- 4. What is the difference between absorbable or non-absorbable?
- 5. What types of mesh products have been subject to lawsuits?
- 6. What should you do if you have been injured by a defective hernia mesh product?
Surgical mesh has been around since 1891 but it wasn't until 1955 they were used widespread. 1 Surgical mesh is a medical implant designed to treat hernias by adding support to damaged or weak tissue. Most mesh products on the market are made of either synthetic or animal tissue. Mesh can be in knitted mesh or non-knitted sheet.
Surgical mesh is used in place of sutures for its lower risk of hernia recurrence.
There are over 70 different hernia mesh products made by different manufacturers. 2 They come in different sizes and shapes and are made of different materials. The design is specific to the type of hernia to be repaired.
There are three basic types of mesh implants:
- Patches. Patches are designed to go over or under the damaged or weakened tissue.
- Plugs. Plugs work like a cork in a bottle. They are designed to fit snug inside the hole made by the hernia.
- Sheets. Sheets of mesh can be cut and fitted to any size according to the patient's needs.
Each type has caused complications that have led to lawsuits. But it is not the type that causes the complications generally, but either the design of it or the materials used to make the implant.
Mesh can be made of different materials. These materials can be categorized as synthetic, animal-derived, or composite / coated. Both synthetic and animal-derived materials can also be coated or uncoated. Synthetic materials can be absorbable or non-absorbable or both while animal-derived mesh is absorbable.
Synthetic mesh are typically mesh products made of some type of plastic. There are many synthetic materials used in mesh products, which indicates there is a “lack of a single best material.” 3 There are, however, four synthetic materials used more so than any other type of synthetic materials.
- Polypropylene (PP) is one of the more widely used synthetic plastic materials. It is preferred because it is both strong and flexible. It is also easily cut and can readily be integrated by surrounding tissues. It is also known to resist infection. Though this is the most popular synthetic material on the market, it is associated with many complications, including infect. The benefit of PP is its ability to have the infection treated without the need -- in many cases -- to have the mesh removed. 4
- Polyester is a mesh composed of polyethylene terephalate (PET). This type of mesh can come in different configurations according to the hernia: inguinal, hiatal, or incisional. The polyester mesh products used for ventral incisional hernia repair are usually coated with collagen. This type of mesh “has been reported to degrade over time, especially during infections.” 5
- Polytetrafluoroethylene (PTFE) is a chemically inert synthetic fluoropolymer with a high negative charge. Due to the negative charge, water and oils do not adhere to it, so the material does not easily integrate with tissue in the body. As such, it becomes encapsulated, which increases the risk of hernia recurrence and infection, among other complications. 6
- Expanded Polytetrafluoroethylene (ePTFE) is an improvement on PTFE. It is more uniform, fibrous and microporous, so it is a stronger material, but it still resists incorporation in the body. As such, it is associated with a high risk of seroma formation and is known to break easily. That said, compared to PP and polyester, it “exhibits minimal inflammatory reaction and comparatively lower scar density.” 7
Even though these materials are known to cause complications, they are still used to manufacture mesh products.
As an alternative to synthetic materials, there are mesh products made out of animal tissue, usually a pig or cow but human tissue is also being used. This biological tissue is rather new compared to the synthetic material.
Its benefit is integration with the host tissue but this often does not happen. The body can react to the mesh, leading to excessive scarring, graft encapsulation, and degradation, which leads to mesh migration and subsequent complications. 8
Biological tissue also is not as strong as synthetic materials, the reason why synthetic mesh still remains more popular among doctors than biological tissue products. 9
When mesh comes into contact with internal organs or tissue, it can adhere to the tissue and cause serious complications. Some manufacturers use coatings in the belief that these coatings prevent adhesion. Coatings can include
- Absorbable fatty acids
- Cellulose, or, among other substances,
Coatings, however, do not necessarily prevent adhesion. Coatings are also responsible for other complications not related to adhesion. A 2009 study found that composite mesh, or mesh with coatings, reduces adhesion in the short-term. 10 The short-term benefit wears off when the coating absorbs into the body, typically a few months. 11 In fact, the study found these types of mesh products actually “contribute to adhesion formation.” 12 Adhesions lead to organ perforation, bowel obstruction, blood loss, infection, fistulas, chronic pain, and other complications.
Surgical mesh implants can be made of absorbable or non-absorbable substances. Both have their unique advantages and disadvantages.
- Non-absorbable mesh is a permanent implant. A permanent implant remains in the body until -- for some reason -- it is surgically removed. Prior to surgery, they are easy to shape so that they can be customized according to the necessary hernia repair. Support from these types of mesh products is meant to provide long-term reinforcement to the repair site given their strength and durability. But they are stiff, and over time, they can cause hernia recurrence, erosion, migration, and adhesions, among other related complications.
- Absorbable mesh, conversely, was created to address the complications associated with non-absorbable mesh. These mesh products are made of a substance that eventually absorbs into the body. The intention is this mesh lasts just long enough for new tissue to grow. But often the mesh degrades and the scar tissue is not strong enough to provide the support the repair site needs. Hernia recurrence is the result of this insufficient support. 13
To address the problems associated with both absorbable and non-absorbable mesh, a hybrid of the two have been created. But it has been found many of the same issues associated with each are now present in the hybrid to some extent.
All types have been subject to lawsuits. The following is a sampling of each type that has been or currently is subject to lawsuits.
- C.R. Bard's Kugel Hernia Plug has caused serious complications, including bowel perforations and death. In 2011, approximately 3,0000 lawsuits were settled for $184 million.
- Atrium Medical Corp currently faces lawsuits over its C-QUR Mesh, a hernia plug coated in fish oil that causes inflammation and allergic reactions.
- Ethicon Inc. is facing lawsuits over its Physiomesh Composite Mesh hernia patches. These patches are known to increase the risk of hernia recurrence, additional surgeries, and other complications. 13
These lawsuits are only the beginning. It is expected -- as it becomes clearer the relationship between defective mesh products and complications -- that lawsuits throughout the U.S. for injuries caused by defective implants will rise sharply in the years to come.
If you believe the mesh product used in your hernia repair surgery has caused you pain and suffering, then you should first contact your doctor. After your medical concerns are addressed, contact an attorney to discuss your case.
At Shouse Law Group, we are accepting cases based on defective hernia mesh products. We have several local offices throughout California but represent clients in the U.S. who have been affected by these kinds of implants. Contact our office today at (855) 396-0370 to learn more.
- Baylon, Karen et al. Past, Present and Future of Surgical Meshes: A Review. Membranes (Basel). 2017 Sep; 7(3): 47. Published online 2017 Aug 22. doi: 10.3390/membranes7030047.
- Bilsel, Y. and Abci, I. The search for ideal hernia repair; mesh materials and types. Int J Surg. 2012;10(6):317-21. doi: 10.1016/j.ijsu.2012.05.002. Epub 2012 May 12.
- Elango, S., Perumalsamy, S., Ramachandran, K., and Vadodaria, K. Mesh materials and hernia repair. Biomedicine (Taipei). 2017 Sep; 7(3): 16. doi: 10.1051/bmdcn/2017070316.
- Supra note 3.
- Fitzgerald, J.F. MD, FACS, FASCRS and Kumar, A.S., MD, MPH, FACS, FASCRS. Biologic versus Synthetic Mesh Reinforcement: What are the Pros and Cons? Clin Colon Rectal Surg. 2014 Dec; 27(4): 140–148. doi: 10.1055/s-0034-1394155.
- Supra note 4.
- Schreinemacher, M.H.F., Emans, P.J., Gijbels, M.J.J., Greve, J.-W.M., Beets, G.L., Bouvy, N.D. Degradation of mesh coatings and intraperitoneal adhesion formation in an experimental model. 17 February 2009.
- Supra note 1.
- In Re: Matthew Huff v. Ethicon, Inc. — Case No. 3:16-cv-00368.