Rosenbaum & Rosenbaum, P.C. | January 25, 2019 | Defective Medical Devices
Have you had a hernia surgery repaired with hernia mesh? Have you undergone or scheduled a hernia revision surgery? You may be eligible to join thousands of other patients in filing a legal claim.
According to the U.S. Food and Drug Administration (FDA), there are over one million hernia repairs a year – most often using hernia mesh. Recent studies show 7.3 percent of hernia mesh repairs result in infection, meaning 73,000 Americans must return to hospitals for revision surgeries and/or additional treatments.
Hernias are repaired by pushing the bulging tissue back into place and strengthening the abdominal wall with stitches and often mesh. Generally, surgeons rely on hernia mesh to reduce recovery time and the high recurrence rate of hernias. There have been no studies on the long-term effects on patients with these types of devices. While many patients do not suffer complications, tens of thousands do.
Some complications will arise within days of surgery, others years later. A 2016 study found that 1,050 out of 3,242 patients experienced no complications for five years or more, before requiring revision surgery.
Hernia Mesh Complications According to the FDA:
- Blockage of the Large or Small Intestine
- Perforated Organs or Tissue
- Abnormal Connection Between Organs, Vessels or Intestines
- Fluid Build-up at Surgical Site
- Migration (the implant moves from its original placement)
- Adhesion (scar-like tissue that sticks together)
- Hernia Recurrence
The FDA’s fast-track 510(k) Clearance Program does not require human clinical trials if manufacturers can prove the existence of similar products on the market. Bard’s hernia mesh was approved by this program.
C.R. Bard has created several problematic hernia mesh devices.
A subsidiary of C.R. Bard, Davol, produced the Composix Kugel hernia mesh – cause for three recalls in 2005, 2006, and 2007 resulted in thousands of lawsuits and millions of dollars in settlement money and jury awards.
The Kugel mesh was recalled for issues with their “memory ring” implants in December of 2005. The patches were designed to be placed through a small incision in the abdomen. After several reports of the plastic memory ring splintering and migrating away from the surgical site, the complications were found to be painful and potentially fatal to patients.
Because of how potentially dangerous the devices could be, the recall was classified as a Class 1 recall – the highest level of recall by the FDA. These dangers include bowel perforation, fistulas, and an abnormal connection between organs.
3DMax, another polypropylene mesh was approved by the FDA in October 2008 and just two months later, Bard recalled the mesh because of mislabeling and generating complaints of pain, migration, and revision surgery. In October 2011, Bard issued a recall of the Ventralex ST Medium Circle with Strap Hernia Patch.
If you have undergone a hernia surgery and are experiencing any complications, we encourage you to contact our firm.