The Björk-Shiley heart valve (implanted in Mexico Hospital patients in the 1980s), resulted in the death of at least 300 people in the countries where it was placed, after the fracture of at least 450 implements was reported.
Between 1979 and 1986, Shiley, Inc., a branch of Pfizer Inc. pharmaceutical company, manufactured between 50,000 and 100,000 valves that were placed on patients around the world. As a result of the deaths, in 1996 a resolution was established in the United States against the cardiac valve manufacturer company, which imposed different types of compensation, from the creation of an economic fund to cover cases of death, injury, and physical and moral damage, as well as the creation of a registry and a follow-up of living patients.
A panel was also established to deal with cases that occurred outside the United States, in order to assure people in other countries the possibility of having the same compensation rights.
However, Costa Rican patients did not receive compensation at any time, despite the fact that the Pan American Health Organization (PAHO), since 1991, communicated the situation to the Health Services Research Section of the Costa Rican Social Security (CCSS), to be reported to the Thorax and Cardiovascular Service Hospital Mexico.
The complaint of seven people (patients and relatives), caused the Ombudsman to initiate an investigation and determined that neither the Mexico Hospital nor the CCSS took action to find and monitor the patients.
Of the people who received the cardiac valve in Costa Rica, 44 have died and 22 remain alive, another eight have not been able to be identified or located. It has not yet been determined if the deceased died from the defective heart valve or from other causes.
The Ombudsman believes that the problem was not addressed in a timely manner and the right to patient information was denied.
Weiner Castillo, the son of a patient who died 20 days after receiving the valve, said that the medical device was removed from the world market in 1986, but at the Mexico Hospital the implants were still used six years later.
Castillo made a call to the population so that anyone with knowledge of a neighbor or relative that received the implant in the 80s or at the beginning of the 90s, contacts him to the numbers 7053-7343 or 7204-8231. He added that they will be suing to the pharmaceutical company and the CCSS for damages.
The Ombudsman’s Office added that the hospital reported that within a period of no more than one month, family members or patients involved would be taken care of to inform about the questions that were not answered at the time.