The following are some of the questions and concerns we have received from our clients and victims of defective hernia mesh products:
What is a hernia?
The answer to the question, “What is a hernia?” or “hernia definition” is answered by medicinenet as follows: “An abdominal hernia occurs when an organ or other piece of tissue protrudes through a weakening in one of the muscle walls that enclose the abdominal cavity. The sac that bulges through the weak area may contain a piece of intestine or fatty lining of the colon (omentum) if the hernia occurs in the abdominal wall or groin. If the hernia occurs through the diaphragm, the muscle that separates the chest from the abdomen, part of the stomach may be involved. The abdominal wall is made up of layers of different muscles and tissues. Weak spots may develop in these layers to allow contents the abdominal cavity to protrude or herniate. The most common abdominal hernias are in the groin (inguinal hernias), in the diaphragm (hiatal hernias), and the belly button (umbilicus). Hernias may be present at birth (congenital), or they may develop at any time thereafter (acquired).” medicinenet
Many people are asking questions such as:
- what is a hernia?”
- What’s a hernia?”
- What is an abdominal hernia?
- What are Inguinal hernias?
- What is an Inguinal hernia?
Should I have hernia surgery?
Many people are asking the following questions:
- Should I have hernia surgery now?
- Should I wait to have hernia surgery?
- What can happen if a hernia is not treated?
- Is it necessary to have a hernia operation?
- Is a hernia surgery serious?
- Is hernia surgery painful?
- hernia definition?
- Will I have hernia mesh problems years later?
According to Kaiser Permanente:
- “Hernias don’t go away on their own. Only surgery can repair a hernia.
- Many people are able to delay surgery for months or even years. And some people may never need surgery for a small hernia. If the hernia is small and you don’t have any symptoms, or if the symptoms don’t bother you much, you and your doctor may simply continue to watch for symptoms to occur.
- Over time, hernias tend to get bigger as the muscle wall of the belly gets weaker and more tissue bulges through.
- Many doctors recommend surgery because it prevents a rare but serious problem called strangulation. This occurs when a loop of intestine or a piece of fatty tissue is trapped inside the hernia and is cut off from its blood supply.
- Talk with your doctor before wearing a corset or truss to hold in your hernia. These devices are not recommended for treating hernias and sometimes can do more harm than good.” Kaiser
How do I know which mesh has been recalled?
The FDA provides data of all recalled products, whether mandated or voluntary. It is very important to know whether the mesh you will be implanted with has ever been subject to a a hernia mesh recall or a hernia mesh removal. We have provided a list of these hernia mesh recalls here:
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?
There are no hernia mesh class action lawsuits in the United States. There are 3 consolidated Multidistrict litigation lawsuits (Physiomesh, Bard / Davol, Atrium C-qur) pending in the United States seeking compensation on behalf of hernia mesh victims.
There are also three State Court hernia mesh consolidated proceedings:
- Bard / Davol Polyproplene mesh-Rhode Island, Providence Superior Court
- Proceed hernia mesh- New Jersey Multicounty Litigation
- Prolene Hernia System– New Jersey Multicounty Litigation
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.
- “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 of 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.” FDA