The following are some of the questions and concerns we have received from our clients and victims of defective mesh products:
How do I know which mesh has been recalled?
The FDA provides data of all recalled products, whether mandated or voluntary. We have provided a list of these recalls here: http://kugelherniameshclassaction.com/defective-hernia-mesh/
I don’t know which mesh was implanted?
The specific mesh that was implanted at the time of your surgery should be contained in your medical file. This may be available at your regular doctor or at the surgeon who conducted the surgery.
I do not want to be part of a class action, may I file my own lawsuit using a hernia mesh attorney?
As far as Ethicon Physiomesh™ lawsuits are involved, these lawsuits are individual lawsuits and not class actions. Also the C-Qur litigation is not a class action. The Composix® Kugel® mesh patches (manufactured by C.R. Bard subsidiary Davol) lawsuits pending in federal Court are also not a class action.
What are FDA Risk Classifications?
Class I: “Low-Risk” Devices. These devices are considered low risk because there is no risk of them causing any life threatening injuries or deaths if not used correctly.
Class I do devices not need FDA clearance. This class of medical devices is governed under other agency rules that pertain to incorrect branding, adulteration, and not providing the required customer information with the device.
Class II Medical Devices. These are medical devices that are not designed to treat conditions that could be fatal. Unlike Class I, however, they are capable of harming the user if not used correctly.
In some instances, the FDA will give consent to a manufacturer to begin selling their device without going through the formal FDA approval process if it is substantially similar to another approved device.
Class III: “High-Risk” Devices. These medical devices are designed to support or maintain life. They are critical in preventing impairment of human health. They present a high risk of injury or death if used improperly.
These devices are designed to be implanted in the body for sustaining or saving lives. Artificial hearts and automated external defibrillators are prime examples Class III devices.
What are the typical complications from hernia mesh?
“Based on FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation).”
“The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).”
“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. 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.” https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm