What is a Hernia?
A hernia happens when an organ or fatty tissue squeezes through a hole, or weak spot in surrounding muscle or tissue, spilling into the next body cavity. Some people are born with weak spots in their muscle and tissue. Other people develop these weak spots as they age. In the United States about 800,000 people per year undergo surgery to repair hernias in the groin region and another 500,000 undergo surgery to repair hernias in the abdominal region.
GoldenbergLaw is currently taking cases of clients who required revision surgery because of complications caused by defective hernia mesh devices such as Ethicon's Physiomesh Flexible Composite Mesh and Atrium's C-QUR surgical hernia meshes, among others. Numerous hernia mesh devices have been identified as problematic, leading to revision surgery and revision surgery complications.
Common causes of hernias generally involve anything that increases abdominal pressure on a regular basis. This includes:
- Heavy lifting
- Improper lifting technique
- Chronic cough
- Lack of exercise
- Poor nutrition
- Chronic constipation
There are six common types of hernias all located around the abdominal and groin regions:
- Ventral: occurs in the general abdominal/ventral wall
- Umbilical: occurs at the belly button
- Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm
- Inguinal or Femoral: occurs in the groin area
- Incisional: occurs in the location where a surgery previously occurred
- Umbilical: occurs in the belly button region
You might have a hernia if you experience the following in your abdominal or groin region:
- Discomfort and pain worse when standing, straining, or lifting.
- A bump that is sore and growing in size.
If the bump becomes too big it gets stuck inside the hole and loses its blood supply leading to nausea, vomiting, inability to pass gas, and inability to have bowel movements. If this happens surgery needs to occur right away.
Doctors can try to see or feel a hernia in order to diagnose the issue. CT scans, ultrasounds, and x-rays of the abdomen may also be used in identifying a hernia.
In rare circumstances the doctor can keep a close eye on the hernia and monitor any changes until it recedes back into proper form, but in most instances surgery is needed.
Open Repair Surgery
Open repair surgery is when the doctor makes an incision in the abdomen and either sutures or patches the abdominal wall tissues back together. Using surgical mesh to patch the abdominal wall can decrease the odds of hernia recurrence.
Laparoscopic surgery is a minimally invasive surgery used to examine the abdominal organs. The surgeon uses a long, skinny tube with a high definition camera and bright light at the end of it. The video is then projected on a larger screen so the surgeon is able to assess what might be causing pain in the abdominal area. Once the hernia is identified, the surgeon is then able to insert the mesh over the tear or hole in the body cavity without any invasive procedures.
What is Surgical Hernia Mesh?
Surgical hernia mesh is used as a patch to support damaged and weakened tissues. Its main purpose is to provide scaffolding so the tissue can regrow and strengthen the weakened area. Surgical meshes are usually made of either synthetic material or animal tissue. When animal tissue is used it usually comes from the intestine or skin of a cow or pig. These materials are absorbable and will eventually degrade as new tissue grows around the mesh. Surgical mesh made from synthetic materials can be absorbable, non-absorbable, or a combination of both.
The most common problems associated with hernia repair revision surgery are:
- Hernia recurrence
- Adhesion (tissues stick together that aren’t supposed to)
- Bowel obstruction
- Tissue or organ perforation
- Mesh migration
- Mesh shrinkage
- Seroma (fluid build-up at the surgical site)
According to the FDA’s analysis of medical adverse event reports, recalled mesh products were the main cause of bowel perforation and obstruction complications. The removal surgery of recalled mesh products is also an unpleasant process. The surgeon has to open up the abdominal area and/or groin area in order to cut each identifiable piece of mesh away from the organ and surrounding tissue. All of this is very painful and requires a longer recovery period than the initial surgery in most cases.
Defective Hernia Mesh Products
This is a hernia mesh product created with polypropylene (plastic) filaments that are woven and then laminated with monocryl – an absorbable coating that prevents the mesh from sticking to surrounding tissue. Polypropylene is a non-absorbent product meaning it is intended not to breakdown within the body. It is designed to be used in laparoscopic abdominal (ventral) and groin (inguinal) hernia repair surgeries.
Physiomesh is manufactured by Ethicon. The product was given FDA 510(k) clearance in April 2010. The product launched in October 2010. It was eventually withdrawn from the market in May 2016 after patients began reporting the following problems:
- No ingrowth of the product into the body
- Bowel obstructions
- Extreme pain
- Hernia recurrence (when the product is meant to be permanent)
- Sernoma (fluid build-up)
- Organ perforation
- Required removal surgery (an invasive procedure)
C-QUR mesh is manufactured by Atrium. The design combines polypropylene mesh with an all-natural Omega 3 gel coating. The gel coating is derived from highly purified pharmaceutical-grade fish oil. C-QUR mesh is used for:
- ventral and inguinal hernias
- chest wall reconstruction and
- traumatic and surgical wounds
The FDA conducted several investigations into Atrium and eventually sued Atrium in 2015. A recall has not yet been issued. Specifically, in 2011, the FDA sent a warning letter to Atrium noting that the company was failing to address multiple complaints related to infections associated with C-QUR hernia mesh. Atrium was also in trouble with the FDA for failing to control temperature in the manufacturing process. In 2013, there was a class II recall of the C-QUR Edge mesh because the Omega 3 fatty acid coating could adhere to the inner packaging liner due to exposure to high humidity. This affected 1,501 devices. In 2015, the FDA sued Atrium and issued an injunction, stopping the manufacture and distribution of the C-QUR hernia mesh at the Atrium Hudson facility.
Patients implanted with C-QUR mesh have reported the following injuries as a result of the device:
- Organ perforation
- Foreign body response
- Chronic pain
- Additional surgery for removal
- Neurological changes
- Dental problems
- Bowel obstruction
- Abnormal liver function