Hospitals using non-FDA approved stents

Sun2Surf PETALING JAYA (Oct 18,2006): All medical implants used in surgical or clinical procedures must be registered with the Ministry of Health.
"There are laws against the use of unregistered medical equipment and interventional implants," the ministry's director-general Tan Sri Ismail Merican told theSun.
He said the Medical Devices Act prohibits clinicians and medical specialists from implanting in patients, any form of mechanical device that has not been approved by the ministry or has not been registered.
Ismail said this after he was informed that several public and private sector hospitals were implanting non-FDA approved stents in patients with clogged arteries.
theSun learnt from several cardiologists, who declined to be named, that they have been using non-FDA approved stents to fix clogged arteries of patients with very unstable angina (chest pain) or who have already suffered a cardiac event.
One cardiologist said he decides on the stents to be used based on the financial status of the patient and the urgency of the situation.
"Non-FDA approved stents are a lot cheaper and within the means of the poor," he said, adding that all angioplasty procedures have attendant risks whether or not they are FDA-approved.
Boston Scientific Corporation, a global developer of interventional medical implants, clarified in a statement on Tuesday that its drug-eluting stent (DES) was not used in the widely reported case of a failed angioplasty performed on a Myanmar national in Singapore in early 2004.
The company provided an assurance that anyone who has used or is planning to use its brand of Taxus Express or second generation Taxus Liberte DES implants may do so confidently as they are safe.
"We assure the medical community that our DES implants were not used in any orm or stage during the afore-mentioned (Singapore) case," its statement said.
The procedure in the said case involved the implanting of an FDA-approved stent in a 64-year-old woman, Daw Tin Nyunt.
In the ensuing court dispute between Daw's family and the Parkway Hospital Group, it was claimed that complications arose when the cardiologist failed to extract the balloon (see graphic) in the stent after the stent was put in place.
The procedure had to be aborted and an emergency by-pass surgery performed instead, due to the balloon having been retained.
The Singapore Sunday Times in a report, quoted a cardiologist in the city-state describing the incident as a "freak accident".
The cardiologist said the number of times the balloon is unable to deflate is one in a million.
Boston Scientific, whose stents are FDA-approved, told the newspaper that the incidence in the case of its stents is 29 in 3 million, whereas Johnson & Johnson - another leading manufacturer of stents - told the paper that of its three million Cypher stents implanted worldwide since 2002, there were only three reported cases of embedded balloons.