Updated August 20, 2021
Mesh used for hernia repair surgery has a high failure rate that can cause serious complications for patients, even years after the implant. Seven common signs and symptoms of hernia mesh failure include bulging, burning, constipation, impotent and sexual dysfunction, nausea, lethargy, and pain.
Depending on your injury, you may need to seek removal of the hernia mesh implant or revision surgery. You also may be able to file a claim for compensation for injuries.
In this article, we will discuss:
- 1. What are the common signs of hernia mesh failure?
- 2. Are some patients more prone to device failure?
- 3. Can you reduce the risk of hernia mesh complications and failure?
- 4. What should I do if I have these symptoms?
- 5. If I have a hernia, should I avoid treating it with a mesh?
- 6. What brands have the highest failure rates?
- 7. Should I get a lawyer if my device failed?
1. What are the common signs of hernia mesh failure?
Failure means that the device used in your hernia repair surgery failed to perform as it should have. Sometimes this is due to a defective mesh product, either from bad design or improper material. Other times this is due to the surgeon’s errors.
Hernia mesh failure symptoms can arise within two weeks of surgery to several years after hernia mesh surgery. Complications can impact your quality of life and even be life-threatening if untreated.1
Seven common complications and signs of mesh device failure are discussed below:
1.1 Bulging
Bulging in the area of the device is often a sign of the mesh dislodging or mesh migration, causing inflammation. Some patients have bulges the size of a softball or greater protruding through their skin. Bulging can also be a sign of hernia recurrence.
This bulging is not merely a cosmetic issue. Bulges can become an infection site and have a build up of fluid (seromas or ascites), and/or spontaneously rupture.
In some patients, these bulges can take a long time to form. In others, these bulges may grow very quickly. They may also cause the patient to wrongly worry that he/she has a cancerous tumor.
1.2 Burning
Warm or hot skin in the area of the implant (surgical site) is also common when the device has dislodged, shrank, or disintegrated. Burning may also indicate that the device has caused an infection.
Depending on the patient, this burning may appear abruptly or slowly increase over time. The burning may also come and go.
For instance, patients prescribed antibiotics may feel some temporary relief as the medication causes the inflammation to subside. But the burning side effect will return once the patient stops taking them.
1.3 Constipation
Defective meshes along the abdominal wall may put pressure on the stomach, small intestines, or colon, causing patients to suffer gastrointestinal problems such as the inability to pass gas or stools. This is especially true for patients with umbilical hernias (where intestine protrudes through the belly button) and who develop scar tissue.
Constipation itself can lead to other painful or dangerous conditions, such as bloating, hemorrhoids, or fissures. And in some cases, the act of straining to use the bathroom may cause fecal impaction or rectal prolapse.
Constipation is a common symptom of many different problems. But anyone with an implanted medical device should take their constipation symptoms very seriously, especially if increasing fiber intake or taking laxatives does not help.
Note that difficulty urinating can also be a sign of mesh failure.
1.4 Impotence
Men with mesh implants may experience sexual dysfunction. This is most common in patients with inguinal hernias (where soft tissue protrudes through the abdominal muscles).
The precise cause of the impotence varies by patient. Sometimes it is due to any inflammation or irritation caused by the mesh. Or perhaps a nerve got caught in the device. In other cases, the patient’s spermatic cord can adhere to the device.
Patients who consult with urologists about their impotence should disclose right away that they have a mesh implant. Otherwise, the doctor may not consider the mesh as a possible cause of their sexual problems.
1.5 Nausea
Like constipation, nausea is a common symptom of several different medical problems. But if the patient has an implanted device, it can be a serious sign that something is wrong.
Perhaps the mesh migrated to the patient’s intestines, causing an intestinal blockage. Or perhaps it caused the stomach tissue to become infected, inhibiting digestion.
Persistent nausea can lead to other problems, including dehydration and an electrolyte imbalance. Therefore, anyone with an implanted medical device who experiences nausea or any flu-like symptoms is advised to consult with a doctor right away.
1.6 Lethargy
It is not normal for patients to feel fatigued once they have recovered from the implantation surgery. Lack of energy can be a sign that the body is not responding well to the device, especially if the patient has a fever and chills as well.
For instance, the patient may be having a poor reaction to the polypropylene mesh material. This can create oxidative stress, which in turn causes white blood cells to create an immune response.
Feeling tired can also be a sign of mesh infection or inflammation as the body is working overtime to fight it. In any case, patients suffering from chronic fatigue are advised to seek medical help quickly.
1.7 Pain
Perhaps the most common sign of mesh failure is pain (often abdominal pain). Pain may be at the site of the implant and/or from other complications the mesh is causing. Pain may be mild or severe, acute or chronic.
It is normal and expected to feel pain in the few days following the implantation operation. But chronic pain that persists may indicate:
- Inflammation,
- Infection, which may require antibiotics and intravenous antimicrobial treatments,
- Adhesion, where scar-like tissues adhere together,
- GI problems, including bowel obstruction (which may require some of the intestines to be removed),
- Organ perforation , which may cause feces to enter the abdominal cavity, which can then cause peritonitis (inflammation) and sepsis,
- Fibrosis,
- Thrombosis,
- Hernia mesh rejection, which typically cause fistulas and abscesses,
- Calcification, or
- Other internal injuries2
Note that pain from a failed hernia mesh can set in months or years after the surgery. Perhaps the device worked for a while but then began to malfunction much later.
Also note that infection is more likely to result from mesh material with tiny pores and that is too heavy. And if the mesh to is too small – or if there is shrinkage – the device can fail.
All people with device implants should stay alert to changes in their body. And if they begin to experience pain, they should consult with a doctor soon.
2. Are some patients more prone to device failure?
Yes. Patients with certain preexisting health conditions have increased chances of complications after hernia repair surgery. Risk factors include but are not limited to:
- Diabetes (type I or II)
- Chronic pulmonary obstructive disease (lung disease)
- Coagulopathy (blot clotting problems)
- Benign prostate hyperplasia
- Obesity
- Jaundice
- Cirrhosis (scarred liver)
- Smoking
- Anemia
- Radiotherapy
- Chemotherapy
- Various autoimmune diseases, such as lupus and rheumatoid arthritis
- Malnutrition
- Chronic steroid use.3
If you suffer from these risk factors and sustained a mesh injury, you still have a legal claim against the mesh manufacturer or your surgeon.
3. Can you reduce the risk of hernia mesh complications and failure?
You can reduce the risk of the device failing if you:
- Eat a healthy, well-balanced diet with lots of fiber and water;
- Exercise on a regular basis, including aerobic exercise;
- Refrain from smoking or using other nicotine products, like vapors; and
- Avoid heavy lifting or activities that strain the abdomen area, especially after surgery. Otherwise, the mesh may rip from the tacks and sutures – causing breakage.
If the device used in your repair surgery was a defective hernia mesh, none of the above suggestions are likely to prevent the device from failing and needing hernia mesh repair.
4. What should I do if I have these symptoms?
Contact your doctor right away and get a CT scan. The physician may also order blood tests, X-rays and MRIs. Diagnostic imaging is often the best way to determine whether your symptoms are caused by the device.
If your doctor brushes off your concerns, seek a second or even a third opinion. Not all doctors have experience with implanted medical devices and their risks. You may need to search around for a physician who understands your symptoms. Left untreated, infections may turn deadly.
These scans can also serve as vital evidence if you sue the medical device manufacturer and/or your surgeon.
5. If I have a hernia, should I avoid treating it with a mesh?
That is a decision for you and your doctor. Certainly, hernias do not repair on their own. In some cases, no surgery will be required. But in most cases, it will be.
Sometimes sutures can be used to repair the hernia. Doctors tend to prefer hernia mesh products for two reasons:
- Recurrence is more likely with sutures; and
- The device reduces muscle tension
When repair surgery is performed — either through open or laparoscopic surgery — the use of devices can help decrease the recovery time. If the device does not fail, patients are often able to return to their daily routines faster than if sutures had been used.
Note that recurrence is more likely following an open rather than laparoscopic repair.4
6. What brands have the highest failure rates?
There are a number of brands that have failed patients. Some of these are subject to hernia mesh lawsuits today. And some of these have been recalled by the FDA (U.S. Food and Drug Administration) as defective medical devices due to adverse event reports.5
6.1 Products Lawsuits
Manufacturers | Products |
Ethicon / Johnson & Johnson | |
Atrium Medical / Maquet, Getinge Group | C-QUR, including meshes and v-patches |
Covidien / Medtronic | Parietex surgical, Composite, or ProGrip |
Bard |
|
6.2 Recalled Products
Brand/Manufacturer | Product | Reason |
Atrium Medical | C-Qur | Improper Packaging — in addition to company real, FDA recalled the device in |
Bard Davol | Composix Kugel | Chance of ring breaking and subsequently causing bowel perforation or fistula |
Ethicon | Proceed | Chance of losing laminate coating and exposing mesh to organs and/or causing adhesion or bowel fistulization; packaging defect |
Ethicon | Physiomesh | Documented high failure rates |
7. Should I get a lawyer if my hernia device failed?
You are not responsible for medical device failure, especially if it was due to a defect. The manufacturers of defective medical products are typically responsible parties.
Your surgeon may also be to blame if he/she implanted the device wrong or made mistakes during your revision surgery. In fact, many surgeons lack the training to do a successful revision surgery.
Through your personal injury attorney, you can file a claim or lawsuit to obtain compensation for any and all damages you suffered. Most law firms offer free consultations and free case evaluations.
References
- Food & Drug Administration. Hernia Surgical Mesh Implants. See also Kukleta, J.F., Causes of recurrence in laparoscopic inguinal hernia repair, J Minim Access Surg. (2006). See also Murphy, B.L., Surgical trends of groin hernia repairs performed for recurrence in medicare patients, Hernia (2019)(in a study, hernia recurrence rates ranged from 14.3% to 13.9%). See also Study finds mixed results for use of mesh for hernia repair, Science Daily (October 18, 2016). See also Kong, et al., Inflammatory reaction to fish oil coated polypropylene mesh used for laparoscopic incisional hernia repair: a case report., BMC Surg (2016).
- Falagas, M.E. and Kasiakou, S.K. Mesh-related infections after hernia repair surgery. Clinical Microbiology and Infection. November 29, 2004. See also Fränneby, U. et al., Risk Factors for Long-term Pain After Hernia Surgery, (August, 2006).
- Radu, P., Bratucu, M., Garofil, D., Pasnicu, C., Popa, F., Strambu, V. Molecular Factors of failure in Incisional Hernia Surgery. Chirurgia. 2013.
- See also Kokotovic, D. et al., Long-term Recurrence and Complications Associated With Elective Incisional Hernia Repair, JAMA (October 18, 2016)(Laparoscopic hernia repair had a cumulative incidence of complications of 3.7%. For open hernia repair, it was 5.6 percent.). See also Itani, K.M.F., New Findings in Ventral Incisional Hernia Repair, JAMA Surgery (October 18, 2016). See also Akyol, C. et al., Outcome of the Patients with Chronic Mesh Infection Following Open Inguinal Hernia Repair, J Korean Surg Soc (April 24, 2013). See also Yansha Qiao, et. al., Synergistic Anti-inflammatory Coating “Zipped Up” on Polypropylene Hernia Mesh, ACS Appl. Mater. Interfaces (July 23, 2021).
- See, e.g., MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MESH COATED WITH OMEGA-3 FISH OIL 7.5 X 12 CM COATED HERNIA MESH, FDA (2011)(lack of tissue ingrowth caused the mesh to float and not stay in place).