If you have been injured by a defective mesh product, it is important to know if any adverse reports were filed on the product used in your hernia repair surgery. It is also useful to understand the adverse event process and what it means before you decide to file a lawsuit for your own hernia mesh injuries.
Below, our personal injury attorneys address commonly asked questions to help you better understand the importance of adverse events related to hernia mesh devices.
- 1. What are adverse events?
- 2. Are adverse events the same as side effects?
- 3. How are adverse events reported?
- 4. When does an adverse event constitute an FDA recall?
- 5. What hernia mesh devices have been recalled due to adverse events?
- 6. When is it time to contact a product liability attorney for a defective mesh medical device?
Adverse events mean any untoward medical occurrence associated with the use of a medical device or “any undesirable experience associated with the use of a medical product in a patient.”1 Adverse events considered serious must be reported to the FDA. Adverse events are considered serious when the patient experiences any one of the following outcomes:
- Death, meaning the adverse event caused the patient’s death;
- Life-threatening, meaning there is a substantial risk of dying;
- Hospitalization, meaning admitted for a hospital initially or for a prolonged stay due to an adverse event;
- Disability or permanent damage, meaning the adverse event substantially interrupted the patient’s “ability to conduct normal life functions” due to the event resulting in:
- significant, persistent, or permanent change;
- significant, persistent, or permanent damage; or
- significant, persistent, or permanent disruption in the patient’s body function/structure, physical activities and/or quality of life;
- Congenital anomaly/birth defect, meaning the exposure to the device adversely impacted the outcome of a child;
- Required intervention to prevent permanent impairment or damage; and
- Other serious but important medical events, meaning the event does not fall under one of the above categories but the event “may jeopardize the patient and may require medical or surgical intervention.”2
There have been some adverse events related to hernia mesh medical devices, namely:
- Death. Though extremely rare, hernia mesh devices have been linked to a few deaths in the United States. The wrongful death lawsuits are ongoing and not yet conclusive that the mesh was the direct cause of the death.3
- Life-threatening events. Many of the complications arising out of mesh products are or can lead to life-threatening events. Of particular concern are the infections that occur. When infections go on too long and untreated, they can lead to blood poisoning, which in turn can lead to sepsis, septic shock, organ failure, and death. Lawsuits against hernia mesh manufacturers include infections as complications and injuries experienced from the defective mesh.
- Hospitalization. Hospitalization has been necessary for many people experiencing adverse events from hernia mesh devices, especially as a result of things like organ perforation, mesh migration, adhesion, mesh removal surgery, and hernia recurrence.
- Permanent damage. Defective mesh devices cause permanent damage to tissue as well as cause permanent injuries like chronic pain. Chronic pain can range from mild to severe and debilitating, depending on the circumstances, the defective mesh, and the patient.
Adverse events can be the same as side effects. But side effects are usually things that can be anticipated or are foreseen while most adverse events are unforeseen — at least initially. Side effects of hernia repair surgery do not necessarily need to be reported to the FDA like adverse events do unless the side effects are serious and constitute a reportable adverse event as those categorized above.
It should also be mentioned that side effects are not limited to adverse effects, but may include beneficial effects. That said, there are no known beneficial side effects associated with hernia mesh devices apart from successfully performing what they were intended to perform: repair hernia mesh without incident or injury.
The FDA oversees all new medical devices on the market. Part of its duties is the management of a reporting system to collect information and identify medical devices that may produce adverse events and other less serious effects. There are two ways adverse events are reported:
- Through a mandatory program that requires manufacturers, importers, and user facilities to report adverse events; and
- Through voluntary consumer reporting.
Manufacturers, importers, and device user facilities (e.g., hospitals, ambulatory surgical facility, outpatient diagnostic facility, nursing home, outpatient treatment facility) are required to report serious adverse reactions.
Manufacturers must use Form FDA 3500A to report adverse events to the FDA.4 Within 30 calendar days of becoming aware of an event, a manufacturer must report:
- Serious injuries, and
Within 5 business days of becoming aware of an event, manufacturers must report an “event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health.”5
Importers have a duty to report adverse events to both the FDA and the manufacturer. Importers must report within 30 calendar days of becoming aware of any deaths, serious injuries, or malfunctions via Form FDA 3500A.6
Device User Facilities
Device user facilities must report within 10 work days of becoming aware of any device-related deaths and/or device-related serious injuries to the FDA or manufacturer. User facilities must report to the FDA and manufacturer with regard to any deaths while they only need to report serious injuries to the manufacturer unless the manufacturer is unknown, in which case the facility reports the serious injuries to the FDA. User facilities use the same Form FDA 3500A for reporting.7
A consumer or patient has the right to report serious reactions he or she experienced with a hernia mesh product. Either you or your healthcare provider can report the adverse reaction to the FDA.
You should know, however, that your doctor is not required to report your incident. To be sure it is reported, ask your medical professional to do so. On the other hand, if for some reason you prefer to report it yourself, you may do so online8 or by completing the Consumer Reporting Form FDA 3500B and either faxing or mailing the completed form.9
When an adverse event (for example, death, serious injury, or malfunction) is occurring, the FDA may investigate and then request a voluntary and temporary recall to give the manufacturer or designer time to make the product safe, correct a label, improve packaging, or otherwise address a concern. Other times, the FDA may deem a mandatory recall is warranted, which may be permanent or temporary. An adverse event constitutes an FDA recall when the investigation of the adverse reports result in evidence confirming the claims.
The FDA recalls are categorized according to the degree of severity:
- Class I recalls are the most urgent and most rare of all recalls. These recalls indicate there is an immediate risk of danger or death. Thus, this class constitutes an immediate FDA recall.
- Class II recalls are less urgent but still present a high risk of harm. Many times these recalls are preventative in nature, i.e., to prevent the potential of a serious injury or death. Thus, this class also constitutes an immediate FDA recall.
- Class III recalls are the least urgent of all. They typically indicate there is minimal or nil risk of serious injury or death but still pose a health risk and/or are otherwise in violation of FDA regulations and must be cured. Thus, when the reporting suggests there is an adverse event — even if minor — then it constitutes a fairly quick FDA recall.
There have been many recalled hernia mesh devices. Some of the more common ones include:
- C.R. Bard and Davol Composix Kugel mesh, recalls began in 200510;
- Ethicon Proceed Surgical Mesh, recalled in 20105;
- Atrium Medical Corporation C-QuR V-pack Mesh, recalled in 201311;
- Ethicon Physiomesh Flexible Composite Mesh, recalled in 201612;
- Atrium Medical Corporation ProLite Mesh patches, recalled in 201813;
- Sofradim Production Versatex Monofilament Mesh, recalled in 201814.
Any hernia mesh that has been subjected to recall may have had a manufacturing or design defect or may have been improperly marketed with inadequate warnings. If your mesh product was recalled for any reason and you experienced complications, then this may qualify you to file a lawsuit. It may be in your best interests to speak with an experienced product liability attorney. Even then, if the mesh product used in your hernia repair surgery has not been recalled, it does not mean it won’t. There are ongoing investigations into adverse events reported to the FDA regarding hernia mesh implants. You should still speak with an attorney to learn more about what options are available to you.
If you have experienced a personal injury from a defective mesh product, you should speak with a medical device product liability attorney immediately. Time is of the essence. The statutes of limitations vary from state to state, but it is usually within 2-3 years from the time of the operation or the time of discovering the injury.
Contact Shouse Law Group today. We have offices throughout California and in Nevada and Colorado.
1. U.S. Food & Drug Administration (FDA). What is a Serious Adverse Event? Last updated 02/01/2016.
4. U.S. Department of Health and Human Services. Form FDA 3500A.
5. FDA. Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities. Last updated 09/27/2018.
6. Same as note 4.
7. Same as note 4.
8. FDA. Report Online. MedWatch Voluntary Reporting Form.
10. FDA. Medical Device Recalls. Bard Composix Kugel.
12. FDA. Class 2 Device Recall CQUR Edge Mesh.
13. Johnson & Johnson. Medical Device Removal of Ethicon Physiomesh Flexible Composite Mesh. 27 May 2016.
14. FDA. Class 2 Device Recall ProLite Mesh.