When you become ill or suffer an injury, you count on the healthcare professionals who treat you to do so carefully and competently. You also likely assume that the medical equipment, devices, and products they use will be safe and effective. Sometimes, however, the medical products we trust and rely on actually do more harm than good. This appears to be the case for many patients who underwent hernia repair surgery that utilized hernia mesh.
What Is Hernia Mesh?
Abdominal hernia is relatively common, resulting in over one million corrective surgeries a year in the United States. An abdominal hernia occurs when the intestines bulge through a weak spot in the abdominal wall. Instead of relying on stitches alone, surgeons may use a loosely woven sheet of flexible mesh to patch the weakness or plug up the hole. One of the most common concerns of hernia surgery is referred to as “reoccurrence,” meaning the hernia comes back. Hernia mesh is supposed to help prevent reoccurrence by reinforcing weakened tissue. The mesh used to repair or strengthen the abdominal wall can be made out of several types of material and is manufactured by a number of companies. However, the mesh has the potential to cause serious negative side effects and complications.
The Problem with FDA Approval
Like most people, you might be under the impression that any medical device or product undergoes a rigorous testing and approval period by the Food and Drug Administration (FDA) prior to being introduced into the market. In reality, that is not always the case. In theory, new products do go through just such a testing and approval period; however, there is a perfectly legal workaround for some new products. Ethicon’s Physiomesh and Atrium’s C-Qur mesh were both released into the market using the FDA’s 510(k) process. That process allows a product to bypass the clinical trial and premarket approval process if the manufacturer can demonstrate that the new product is substantially equivalent to another legally marketed device. In essence, this fast track process allowed potentially-defective products to enter the market without first being required to prove that they are safe.
Common Hernia Mesh Side Effects and Adverse Reactions
An Ethicon Physiomesh study showed that the mesh has a much higher failure rate than other widely available hernia mesh products with 20 percent of Ethicon Physiomesh implants failing within six months of implantation. When the hernia mesh implant fails, the patient must undergo hernia revision surgery. Further, with each surgery, scar tissue build-up makes every revision attempt less likely to succeed. For a patient, the physical, emotional, and financial impact of these negative side effects can be enormous. Other common adverse reactions associated with hernia mesh include:
- Bowel obstruction — if the hernia mesh adheres to the intestines, a bowel obstruction can occur. This can also happen if the mesh migrates in the body. Left untreated, a bowel obstruction can cut off the flow of blood, causing part of the intestine to die. A secondary surgery may be required to remove the affected portion of the intestine.
- Bowel perforation — this occurs if the hernia mesh erodes into the bowel or punctures the bowel. Perforation may also occur to other nearby organs or to the abdominal wall. If a perforation of the bowel happens, fecal matter and bacteria can enter the abdominal cavity, causing peritonitis, a dangerous form of inflammation. Even more worrisome is the possibility of sepsis, a potentially fatal bloodstream infection.
- Infections — hernia mesh can cause chronic, deep infections that may require surgery to remove the mesh.
- Rejection — the hernia mesh may trigger the body’s immune response resulting in rejection of the mesh. If that occurs, the mesh can migrate through the abdomen, causing fistulas, hernia mesh adhesion, and abscesses.
Symptoms and Signs of Hernia Mesh Failure
Unfortunately, the symptoms and signs of hernia mesh failure do not always manifest right away. In fact, it can be years after implantation before a patient recognizes the signs. Moreover, because some symptoms mimic those of common ailments such as the flu, patients may not immediately associate those symptoms with an adverse reaction of a hernia mesh implant. Some of the most common symptoms of mesh failure include:
- Recurrence of the hernia
- Fever and/or chills
- Nausea or vomiting
- Pain or swelling at the operative site
- Inability to pass gas or stool
- Abdominal rigidity
- Fluid-filled abscesses in the abdomen and groin
- Flu-like symptoms
If you are a hernia mesh patient and you experience any of these symptoms, or you are otherwise concerned about mesh failure, consult with your physician immediately as some causes of mesh failure can become life-threatening if left untreated.
Ongoing Hernia Mesh Litigation
The pervasiveness and breadth of negative side effects caused by hernia mesh has resulted in litigation. Given the large number of potential plaintiffs, much of the litigation involving hernia mesh injuries has taken the form of multi-district litigation (MDL). Multi-district litigation takes numerous civil lawsuits that involve common factual issues, grouping them together; however, with MDL each case proceeds through the litigation process separately.
As of 2019, the following hernia mesh lawsuits have been consolidated into Multi-District Litigation:
- Ethicon Hernia Mesh MDL — established in 2017, MDL No. 2782 (RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation) consolidated more than 1,200 Physiomesh lawsuits involving the Ethicon Physiomesh implants in the U.S. District Court for the Northern District of Georgia. Ethicon voluntarily withdrew Physiomesh implants from the market back in 2016 when studies involving the implants pointed to higher than normal failure rates when compared to similar hernia mesh products on the market.
- Bard Hernia Mesh MDL — an initial round of MDL litigation involving faulty Kugel Composix hernia mesh patches ended in 2011, with an agreement requiring Bard to compensate the majority of the 3,600 cases using a $184 million settlement fund. The Kugel patch has been off the market since its voluntary withdrawal in 2005, following evidence that manufacturing defects caused injury to nearby organs. In 2018, a second hernia mesh MDL (Polypropylene Hernia Mesh Products Liability Litigation, MDL No. 2846) was initiated against Bard and Davol, a Bard subsidiary, and as of this writing is currently underway in the U.S. District Court for the Southern District of Ohio.
- Atrium Hernia Mesh MDL — after receiving an FDA warning letter the previous year, Atrium issued a Class 2 FDA recall of C-Qur mesh in 2013 because of an increased risk of infection caused as a result of the coating sticking to the package lining if exposed to high levels of humidity. MDL No. 2753 commenced in the United States District Court District of New Hampshire in 2016. This litigation involves over 1,000 plaintiffs with claims against Atrium Medical Corporation over its C-QUR hernia mesh inserts.