Side effects are therapeutic or adverse effects of a medical procedure, medical treatment, or medicine that are secondary to the intended purpose of the treatment or drug. Hernia repair surgery using mesh has known side effects, which are primarily adverse events. Patients should be informed of the known side effects prior to making the decision to undergo hernia repair surgery. Medical professionals should also be informed of any known side effects of a particular mesh product to be used in the hernia repair surgery.
Experiencing a known side effect from a medical device like mesh products typically does not qualify a person to file a lawsuit unless the device was defective and due to the defect, the injury was caused.
It is important to be able to distinguish between when a side effect qualifies as an injury for the purpose of a claim and when it does not qualify for the same. Below, our personal injury attorneys provide an overview of the known side effects of mesh products in hernia repair surgery.
- 1. When can a person file a hernia mesh lawsuit for injuries resulting from hernia repair surgery?
- 2. What are hernia repair surgery side effects?
- 3. Are there side effects specific to mesh implants?
- 4. Are there mesh implants that are more prone to causing adverse side effects?
- 5. What side effect symptoms may indicate you have a serious condition?
- 6. Should you report side effects you experience from hernia mesh repair surgery?
- 7. How can you tell if a side effect is actually a complication caused by a defective mesh implant?
- 8. When should I contact a product liability attorney for a hernia mesh lawsuit?
You can file a claim or lawsuit for injuries stemming from mesh medical devices if the following conditions are present:
- You had hernia repair surgery and mesh was used for the repair.
- The mesh used for the hernia repair was somehow defective:
- manufacturing defect;
- design defect; or
- warning defect.
- The defective device was the direct and proximate cause of an injury.
- The injury can be quantified in monetary terms.
Side effects are unintended symptoms that result from some type of medical treatment or use of medicine. Side effects can be therapeutic or adverse. All medicines and any type of surgery can cause side effects. Each person is different and their bodies respond differently to medicine and medical treatment. Side effects can range from mild to life-threatening. Before taking any medicine or surgery, your medical professional or a pharmacist will advise you of the side effects. With medicine or medical devices, side effects are also outlined in the packaging.
With respect to hernia repair surgery, whether it is laparoscopic or open hernia repair surgery, there are side effects. Some of the most common side effects that can be attributed to any type of hernia repair surgery include:
- hernia recurrence;
- scar-like tissue that sticks tissues together (adhesion);
- blockage of the large or small intestine (bowel obstruction);
- abnormal connection between organs, vessels, or intestines (fistula);
- fluid build-up at the surgical site (seromas); and
- a hole in neighboring tissues or organs (perforation).1
Some of these side effects should wane and reduce in severity over time, usually within one or two months but could take up to one year. Other side effects may not appear until years later and/or require long-term treatment.
Recovery is usually quicker with laparoscopic surgery compared to open surgery.
Any patient who has hernia repair surgery completed with a mesh implant can experience any of the above side effects. There are, however, some adverse side effects that are specific to mesh medical devices. These side effects are:
- mesh migration;
- mesh shrinkage (contraction);
- chronic pain;
- mesh failure2; and
- delayed and/or long-term consequences.
The above-listed side effects can occur regardless of the brand of mesh implants, but the FDA confirms that most of these complications are “associated with recalled mesh products that are no longer on the market. … In the FDA's analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.”3
Examples of recalled mesh implants include:
- C.R. Bard and Davol Composix Kugel mesh, recalls began in 20054;
- Ethicon Proceed Surgical Mesh, recalled in 20105;
- Atrium Medical Corporation C-QuR V-pack Mesh, recalled in 20136;
- Ethicon Physiomesh Flexible Composite Mesh, recalled in 20167;
- Atrium Medical Corporation ProLite Mesh patches, recalled in 20188;
- Sofradim Production Versatex Monofilament Mesh, recalled in 20189.
Whenever after surgery you feel something is not right, then you should always check with your doctor. But there are certain symptoms of side effects that -- if present -- may indicate you have a serious condition. The following symptoms require medical attention and may also mean you qualify for a hernia mesh lawsuit.
- Inflammation. Inflammation can be a good side effect when it nurtures the growth of tissue around the mesh product, thus, allowing for a stronger bond and less likelihood of migration. But inflammation can also lead to infection and chronic pain. Polypropylene, a type of plastic used in many mesh products, is known to cause inflammation that has adverse effects.
- No healing. When the wound at the incision site becomes infected, the infection may prevent the wound from healing. This can cause a seroma, which can be very painful. So long as the wound at the incision site does not heal properly, the hernia repair itself may not heal properly.
- Symptoms Similar to the Flu. Nausea and vomiting are sometimes present after surgery, but when accompanied by fever and chills, it may be an indication that there is an infection. Most know to cause flu-like symptoms is Atrium's C-Qur hernia mesh. The latter has an omega 3 fatty acid coating that can cause an adverse reaction in a patient's body.
You should always report side effects you experience from hernia mesh repair surgery. The first place to report the same is with your doctor. If the side effect is substantial, the doctor will report it to the FDA. You, too, as a patient can report it directly to the FDA, too.10
Oftentimes the signs of a defective mesh product are the same as the side effects to be expected after hernia repair surgery, especially after repair using mesh products. You will want to know, first, if the mesh used in your surgery has since been recalled by either the manufacturer voluntarily or by the FDA. If it has not, then it could be others with your same mesh product are experiencing the same side effects -- if so, then there may be a reason to believe the mesh used in your surgery may need to be recalled due to a defect.
In either scenario, it may also take an expert to confidently determine that you complications are the result of a defective mesh implant.
If you have been experiencing complications after hernia repair surgery where a mesh implant was used, regardless if it is immediately after the surgery or years later, always make sure you receive proper medical attention. Complications can lead to life-threatening health conditions.
After your medical needs have been met, you should contact a product liability attorney to learn more about whether or not you are entitled to file a lawsuit. At Shouse Law Group, our product liability and personal injury attorney are experienced and resourceful. We have local offices throughout California and in Nevada and Colorado. Call us today to learn more about your options with regard to a hernia mesh lawsuit.
- U.S. Food & Drug Administration (FDA). Hernia Surgical Mesh Implants. Last updated 02/04/2018.
- FDA. Medical Device Recalls. Bard Composix Kugel.
- FDA. Class 2 Device Recall PROCEED Surgical Mesh.
- FDA. Class 2 Device Recall CQUR Edge Mesh.
- Johnson & Johnson. Medical Device Removal of Ethicon Physiomesh Flexible Composite Mesh. 27 May 2016.
- FDA. Class 2 Device Recall ProLite Mesh.
- FDA. Class 2 Device Recall Versatex Monofilament Mesh 50 x 50 cm.
- FDA. How Consumers Can Report an Adverse Event or Serious Problem to FDA.