Composix Kugel hernia mesh patches have been used for years to repair ventral hernias. These hernias can occur in a patient when scar tissue, due to a surgical incision, becomes extremely thin due to stretching.
The FDA originally approved the Composix Kugel hernia mesh patches in 1996. This product is developed by a subsidiary of C.R. Bard known as Davol Inc.
Lawsuits allege that both companies are responsible for the harm done to patients as a result of improper design and manufacturing.
Many people have received this product during hernia repair surgery, a treatment they expected would help them recover and heal.
The patch, however, has recently been tied to serious injury risk. The memory recoil ring may ultimately break and cause severe injuries. This is why certain sizes of the Composix Kugel hernia mesh patch were already recalled between 2005 and 2007.
In January 2007, more than 100,000 units of the Composix Kugel hernia mesh product were additionally recalled because the FDA received 34 reports from users that the ring had broken.
At least one of those instances resulted in death. The memory coil ring allows a patch to be placed through a small incision known as laparoscopic surgery.
The patch is folded up so that it easily slides in through the incision location and then pops open inside the body. It is intended to lie flat once it has been placed. The advantage of this surgery is that it causes less damage to the surrounding tissues.
Any item placed inside the body that has the potential to break down or cause problems with nearby tissues could lead to pain and inflammation for the patient. Some patients experience pain in the immediate aftermath of the procedure whereas others develop it over time.
However, the memory coil ring in the patch could break or bend. This could lead to very serious injuries and complications for a patient.
The complications and side effects may be noticeable immediately or may appear down the road. The dangers presented by a defective Composix Kugel hernia mesh include:
- Bowel obstruction
- Bowel perforation
- Fluid in the abdomen
- Abdominal abscess
- Sepsis
- Hernia recurrence
- Bowel paralysis
- Migration of the ring through the patient’s abdominal wall
- Perforation of the intestinal wall
- Pelvic inflammatory disease
A patient may notice this issue after developing nausea, diarrhea, fever, distended abdomen or severe abdominal pain. Certain sizes of the Composix Kugel hernia mesh were recalled in 2005, 2006 and 2007.
Patients who already had recalled units inside their bodies were warned to be aware of device failure signs.
A 2011 settlement involved more than 2,600 lawsuits filed by patients who suffered serious injuries because of the Composix Kugel hernia mesh patch.
Many people, however, are just discovering these side effects associated with this situation and may need their own assistance.
If you or someone you know has already been injured because of a hernia mesh patch, get support from the lawyers at McDonald Worley.