Surgical Mesh Complications: Should You File Suit?
Years ago, before the advent of surgical mesh, doctors hand sutured weakened or damaged tissue such as hernias, surgical wounds, and vaginal wall and pelvic prolapse. Yet what they found, particularly with hernia repair, was that between 24% to 54% of patients needed an additional repair operation, reports the New England Journal Medicine (NEJM) in 2000.
The answer to this problem was thought to be surgical mesh and during the 1970s, the product gained popularity. What we learned over the ensuing years was that patients didn’t fare much better with mesh. The NEJM reported in that same study that surgical recurrence rate for mesh patients was still as much as 34%. Meanwhile, many mesh patients have had to live with recurring surgeries, physical and emotional pain, misery, and life-altering complications from surgical mesh repair.
The NEJM stated in this study that it is uncertain whether mesh repair is superior to suturing. Even so, the surgical mesh market continued to grow into what is now a multi-billion dollar industry.
What Is Surgical Mesh?
Surgical mesh can be made from organic material (pig or cow organs) or synthetics, such as polypropylene plastic. It is used to shore up damaged tissue like a hernia, pelvic prolapse (vaginal mesh), or other weakened tissue from surgical repair. Similar to patching a screen door.
Surgeons began using synthetic mesh because it is easier to work with. It seemed like a win-win for everyone. Surgeons. Patients. And the mesh manufacturers. Mesh has gained so much momentum in the past 25 years that the FDA cleared 168 applications for surgical hernia mesh just for urogynecologic use, alone.
Complications From Surgical Mesh
When a surgical mesh repair fails, severe complications can occur.
The Journal of the American Medical Association (JAMA) reports that about one-third of patients experience complications that may not present until five years later. The article concludes, “With long-term follow-up, the benefits attributable to mesh are offset in part by mesh-related complications.”
These complications can include:
- Adverse reactions to the mesh, such as pain, swelling, discharge from the surgical site (or abnormal vaginal discharge in the case of transvaginal mesh).
- Adhesions (when tissue adheres to the mesh), which some describe as burning, itching, poking or stabbing.
- Injuries to nearby organs, nerves, or blood vessels.
- Bowel obstruction, which can be life threatening. Early symptoms are fever, abdominal pain, nausea and vomiting.
- Infections, such as fever, tenderness, and discharge around the surgical site.
- Repair, which can often be riskier and more complicated after mesh failure because tissue and muscle typically adhere to the mesh and must be removed with the problematic mesh.
The Problem With Surgical Mesh
While there are thousands of lawsuits over surgical mesh, most stem from the following:
- Many are synthetic and made of polypropylene plastic and coated with substances that have reportedly caused severe adverse reactions.
- Potentially toxic counterfeit mesh imported from China was allegedly used (knowingly) by at least one mesh manufacturer and unknowingly by another.
- Many were pre-approved through the FDA’s 510(k) approval process, a regulatory loophole that does not require safety testing.
- The products were allegedly heavily marketed by mesh manufacturers without appropriate safety studies.
You can read more about these topics below.
Synthetic Polypropylene (Plastic) Surgical Mesh
Surgical mesh can be made from animal tissue or synthetics like plastic. Those found to be particularly problematic are made from polypropylene (plastic).
A Polypropylene Material Safety Data Sheet from the manufacturer of the plastic prohibits using polypropylene for permanent implantation in the body.
The body naturally fights off anything it sees as a foreign object, similar to when you get a splinter in your finger. Polypropylene is a foreign object the body will try to break down. But it can’t completely. Add to that the addition of the coatings of Omega 3 fatty acid layers of the C-Qur brand hernia mesh, and various coatings other manufacturers use. More foreign substances for the body to attack.
As the body attacks these invaders, the mesh composition changes and can often become rock hard. Once hardened, it will never soften again and can lead to life-long pain in and around the mesh area. This solid rock-type substance can lead to irreparable nerve damage.
Was Tainted Chinese Polypropylene Knowingly Used?
It is alleged that Boston Scientific, after losing their polypropylene supplier for one of their vaginal mesh products, covertly looked to China for the polypropylene it needed to manufacturer their vaginal mesh. Thousands of lawsuits against Boston Scientific suggest that they potentially smuggled counterfeit mesh from China (untested by the FDA) and that this mesh could potentially have unsafe and toxic levels of selenium in it.
The FDA acknowledged in 2016 that Boston Scientific could have potentially used counterfeit polypropylene and is investigating.
Mesh Approved Without Safety Studies
When a drug or medical device manufacturer wants to save time and money and rush a product to market, there’s a loophole in the FDA approval process in certain instances. The 501(k) approval process allows a manufacturer to skip the testing and approval process if they can show their product is “similar to those already cleared” for patient use. All the manufacturer needs to do is show the FDA evidence substantiating that their device is similar to those already approved on the market and that it appears to be safe.
In 1996, the FDA approved Boston Scientific’s ProteGen mesh to treat stress urinary incontinence. Two years later, Johnson & Johnson’s Gynecare mesh was approved under 501(k) citing ProteGen’s approval. And so on and so on until more than 168 surgical mesh products had been approved under 501(k) by 2010.
What is noteworthy, is that less than a year after ProteGen (the device upon which the other mesh manufacturers based their claims for approval) was approved it was yanked off the market after more than 100 complaints of discomfort, pain, and tissue erosion.
Even so, Johnson & Johnson’s product and many others remained in use. Finally in 2012, Johnson & Johnson pulled some of its mesh products.
The American College of Obstetricians and Gynecologists says that surgical mesh should be further tested for safety and used only as an experiment in clinical trials until its safety is proven.
Heavily Marketed Mesh
The British Columbia Medical Journal (BCMJ) and others report that mesh was marketed very aggressively with minimal evidence of their safety:
“Regrettably, while considerable resources were marshaled to develop these devices, minimal corporate funds were dedicated to proving clinical efficacy. In fact, these devices have been heavily marketed with minimal evidence for safety or efficacy, which is a primary concern of many of the opponents of these procedures.”
The International Journal of Women’s Health states that the supposed “need” for vaginal mesh was based on studies with incorrect information regarding the failure rate of other types of surgical repair:
“The main rationale for mesh use was the hypothetical reduction of the high recurrence [of repair] after standard vaginal surgery without mesh, with an average 30% rate of reoperation. This rate was often cited in subsequent publications as an incentive to justify and sustain [mesh] strategy. We know now that this initial postulate was probably wrong, but under mounting pressure from the industry, production of meshes and new procedures were introduced before evidence of its benefit was established.”
Recent Mesh Recalls
Atrium C-Qur Mesh Recall
In 2013 the FDA announced that Atrium recalled thousands of C-Qur V Patch meshes and C-Qur Edge mesh. High rates of infection, bowel obstructions, and allergic reactions to the C-Qur fish oil coating on the mesh have sparked lawsuits. Moreover, the C-Qur mesh is difficult to remove if it becomes attached to the bowels.
Ethicon Physiomesh Recall
In May 2016, Ethicon (a division of Johnson & Johnson) released an Urgent Field Safety Notice for Ethicon Physiomesh Composite Mesh and its Laparoscopic Hernia Kits. It withdrew these products from the market due to “higher than average” recurring operations following product use.
In 2014, Ethicon also recalled its Proceed mesh. According to the recall announcement, incomplete seals on the product could lead to compromised sterility.
FDA and Other Mesh Warnings
Over the years there have been dozens of mesh warnings, communications, and recalls. Here are some of the more recent ones.
In January 2016 the FDA reclassified transvaginal mesh from Class II to Class III – the highest risk and subject to the highest level of regulatory control. Further the agency gave all transvaginal mesh manufacturers 30 months to prove product safety.
In 2016 the FDA acknowledged the potential for counterfeit materials being used in Boston Scientific’s pelvic mesh.
In 2014 an FDA Safety Communication warned about complications reported to the agency regarding surgical mesh.
In 2011 the FDA issued a counterfeit warning about the possibility that some vaginal mesh products were distributed under the C.R. Bard/Davol brand name, but were not manufactured by the company.
In 2011 the FDA issued an update to serious complications resulting from vaginal mesh.
Personal Injury Lawyers Offer FREE Case Evaluation
Mesh manufacturers have settled thousands of lawsuits with victims who have accused them of making defective products, fraudulently promoting their safety, and not making the doctors or the public aware of potential problems, including the potential for additional surgeries to replace faulty mesh.
If you or a loved one have experienced pain or other complications or have had revision surgery as a result of mesh used in any kind of surgery, contact us today. You may be eligible for compensation for:
- Medical expenses
- Lost wages
- Emotional and physical pain and suffering
- Other damages
The Law Offices of James Scott Farrin consults with a national network of attorneys on product liability, defective drugs, and defective products cases in an attempt to provide the best representation we can for our clients. Depending on the details of your case, our firm will likely refer your matter to another law firm with which we associate. We will only do this if we believe it is in your best interests and if you agree.