To sum up

To sum up, the Bjork-Shiley tilting disk heart valve was intended to overcome the intense requirement of anticoagulant and thrombosis which was the main problems of the caged-ball heart valves. There is no doubt that it highly reduced thrombosis effect but due to faulty design concept, flawed manufacturing practices and characteristics of patients it was accompanied by outlet strut fracture and claimed many lives.
Even if the Shiley company knew the occurrence of fracture, it implements the “Earn as you learn” policy and continued supplying the product while investigating the problem. It can be clearly seen that the medical devices regulatory requirements were not strong enough to enable the FDA to take action on the B.S. heart valve in time.
The Bjork-Shiley heart valve case presented ethical questions both for the system of regulation and for the individual responsibilities of bioengineer. In addition to withdrawal of the B.S. heart valve from the market in 1986, the case also enabled the FDA to ratify strong regulation requirements on medical devices. Finally the company incurred $20.75 million fine by the government and spent a lot of money to create a continuing fund for researches to follow up the B.S. valve integrity non-invasively.