A medical device is a tool designed to facilitate providing a healthcare service to a patient. From blood glucose testers to wheelchairs to sophisticated heart monitors, medical devices provide non-pharmacological solutions to often-complicated medical questions.
Unfortunately, like any other tools or consumer products, medical devices sometimes fail or cause unanticipated damage. This can be due to the way they are designed, the way they are manufactured, or the way doctors and patients are directed to use them. Medical devices that pose health risks are often recalled, either by the Food and Drug Administration (FDA) or by their manufacturer.
The cost of using a defective or poorly designed medical device is high — physically, emotionally and financially — and in some cases, using a defective medical product even has fatal consequences. Recent examples of defective medical products in the news include the following:
Metal-on-metal hip replacements — In August 2010, the DePuy ASR XL Asetabular System hip system, manufactured by a subsidiary of Johnson & Johnson, was voluntarily recalled due to early failure rate and metallosis, a buildup of metal particles in the body of recipients. Despite this recall, complaints continued to mount in 2012. Experts from the world’s largest artificial joint registry recently called for doctors to cease use of metal-on-metal hip systems.
Transvaginal surgical mesh — Transvaginal mesh and bladder slings are devices used to treat women suffering from pelvic organ prolapse and/or stress urinary incontinence. Both have been linked to a litany of complications, the most serious of which include erosion through the bladder or vaginal walls and serious infection. Thus far mesh products that have been voluntarily recalled include Boston Scientific’s ProtoGen mesh and Mentor Corporation’s ObTape Vaginal Sling.
Posted in Products Liability
Tagged defective medical devices, products liability, products liability attorneys