- Lack of Mesh Regulation Leads to Lawsuits
- December 5, 2018
Medical devices are more common in American society than one might believe. Seventy million Americans have a medical device implanted within their bodies. Even the doctors implanting the devices often fail to appreciate how loosely regulated this industry is. No wonder these very same devices can cause injury and pain, and lead to death.
The surgical mesh used for hernia repairs can result in severe and deadly complications. Of people receiving surgical mesh, nearly a third required additional surgery or experienced complications, according to a 2016 study. More recently, court filings show that consumers have filed more than 50,000 lawsuits against manufacturers of mesh implants.
When Medical Device Regulation Falls Short
Prior to the sale and use of any medical device, it must undergo review by the FDA for safety and efficacy. In recent years, the process for getting medical devices to market has accelerated as manufacturers push for faster device approval and less rigorous examination.
Frequently, the FDA clears a new device, prosthesis, or implant based on “substantial equivalence” to an existing device that is already FDA-approved — including devices that may have been recalled. This means that products may be cleared for sale by the FDA without undergoing any independent testing. When manufacturers changed the design of the mesh devices used in hernia repairs — those changes were fast-tracked due to their supposed “substantial equivalence” to other devices and not tested. Furthermore, many medical devices are not tested in humans. Those that do receive testing often undergo trials lasting only a matter of months. In some cases, the design of the mesh implant was never tested for the purpose in which it was used.
How Does Hernia Mesh Fail?
Hernias are the bulges that occur when an internal organ pushes through the wall of muscle or tissue surrounding it. When left untreated, hernias can lead to discomfort, pain, and dangerous conditions such as intestinal blockages and gangrene. The Food and Drug Administration (FDA) estimates that there are more than one million hernia repairs each year — many using surgical mesh. Areas of the body where some of the most common types of hernias occur include:
- Groin (inguinal hernia)
- Top of the inner thigh (femoral hernia)
- Abdomen (hiatal hernia)
- Between the navel and sternum (epigastric hernia)
- Site of a surgical incision (incisional hernia)
- Bellybutton (umbilical hernia)
Hernia mesh, composed of synthetic materials such as polypropylene, is used by doctors to provide support to a patient’s weakened or damaged muscle tissue where hernia bulges have developed. More than 90 percent of abdominal wall hernia repairs (including inguinal hernias) are performed using hernia mesh. This type of medical device is considered to be a permanent implant.
However, despite the popularity of mesh implants, complications can and have occurred resulting in severe and potentially deadly hernia mesh injuries including:
- Bowel obstruction and perforation
- Migration or movement of the implant
- Adhesions (scar-like tissue that binds or connects tissues not normally connected)
- Additional surgeries