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The documentary explores the FDA's 510(k) process which allows a medical device to be fast-tracked onto the market with less clinical study and human testing. The film also explores problems with hip replacement devices that can lead to cobalt poisoning and vaginal mesh devices that injured multiple women.
In 2006, the United States FDA approved hip resurfacing using the Birmingham Hip Resurfacing (BHR) system, designed by British Orthopaedic surgeon Derek McMinn. All other FDA approved devices have been removed from the US Market. The BHR is no longer suggested for use in women.
However, the FDA's 510k approval process allowed companies to have new and "improved" metal-on-metal hips approved without much clinical testing. Some people with these prostheses experienced similar reactions to the metal debris as occurred in the 20th century; some devices were recalled.
The recent FDA go-ahead for Zimmer Biomet's (ZBH) ROSA Hip System will aid surgeons perform robotically-assisted direct anterior total hip replacement surgery.
The latter was the first surgical robot that was approved by the FDA in 2008. The ROBODOC from Integrated Surgical Systems (working closely with IBM) could mill out precise fittings in the femur for hip replacement.
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The many examples of implant failure include rupture of silicone breast implants, hip replacement joints, and artificial heart valves, such as the Bjork–Shiley valve, all of which have caused FDA intervention. The consequences of implant failure depend on the nature of the implant and its position in the body.