The manufacturing of medical devices is big business. For the most part, medical devices help to save people’s lives and promote health.
Unfortunately, there are countless numbers of deaths and serious injuries reported to the U.S. Food & Drug Administration (FDA) every year regarding these same products.
The FDA is charged with protecting patients of drugs and medical devices from unreasonable risks of serious injury or death from thousands of types of products. However, this government agency is underfunded and overwhelmed with adverse events and injury reports. The number of medical device and consumer product recalls and warnings issued each and every year in the United States is simply astounding.
Our Medical Device Attorneys at Aaronson & Rash, PLLC are currently accepting new clients for the following cases:
A Bair Hugger is a medical device used to warm patients before, during and after surgery. Warm air is blown through a hose into the Bair Hugger blanket to keep the patient warm. A New York Times article reported that the forced air used to warm the blankets can spread bacteria associated with hospital-acquired infections. The bacteria contaminated air is in then deposited into a person’s implanted device or open surgical wound causing severe infections.
Essure is a non-surgical birth control device inserted by a doctor into a woman’s fallopian tubes. The nickel-based metal coil’s purpose is to cause blockage of the fallopian tubes preventing pregnancy. From November 2002 to May 2015, the FDA received more than 5,000 medical device reports on Essure. Patients experienced problems including device movement and coils breaking which causes perforations of the fallopian tubes.
The recall of “on the shelf” products should serve to prevent future hernia repair patients from being implanted with Physiomesh however, this recall does not help those already implanted with the defective hernia mesh product. The defective design causes delayed wound healing, inflammation, foreign body response, rejection, infection, and other complications. When the Physiomesh degrades, the polypropylene mesh is exposed to the adjoining tissue and becomes adhered to organs, causing bowel perforation or erosion, fistula formation, bowel strangulation, hernia incarceration and other injuries.
An IVC Filter, or inferior vena cava filter, is a small medical device that is implanted into a blood vessel with the same name. The metal spider looking device is supposed to reduce a patient’s risk of death by preventing blood clots from moving from a patient’s legs to a patient’s lungs, heart or brain. Studies have shown that sometimes the filter breaks apart and metal pieces move to other parts of the body causing perforations in organs including the heart and lungs. In August 2010, the FDA issued an advisory after it had received 921 adverse event reports including filter migration, embolization, IVC perforations and filter fracture.