57 contracted HCV from surgical glue / People infected in Tokyo during heart surgery

At least 57 people were infected with the hepatitis C virus after heart surgery in which a surgical tissue adhesive was used, according to a private hospital in Tokyo where the operations took place.

The surgical adhesive, called fibrin glue, was made from an HCV-tainted fibrinogen blood product manufactured by the defunct Green Cross Corp.

People infected with the disease via the glue are eligible for remedy under the law enacted Friday that sets outs provisions for blanket relief to HCV sufferers who contracted the disease through virus-tainted blood products.

The tainted glue is estimated to have been used on about 79,000 patients, mainly between 1981 and 1987, but only two have joined the HCV sufferers groups that filed lawsuits against the government and the pharmaceutical company to assign responsibility for the spread of of the virus via the contaminated products.

An investigation by the Health, Labor and Welfare Ministry revealed that another 50 people or so are suspected of having been infected with HCV via the glue.

The discovery of this problem at the Tokyo hospital highlights how the ministry's efforts to identify suspected victims of the contaminated glue have been lagging.

According to the hospital, it inspected medical records and other documents on 3,138 heart operations carried out there between 1980 and 1989.

Through these documents it was learned that fibrin glue was used during operations on 930 patients to join blood vessels and other organs. Some of the 930 also were given blood transfusions during their operations.

The hospital was able to contact about 500 of the 930 patients via telephone and letter, informing them about the use of the glue during their operations and encouraging them to take an HCV test.

The hospital obtained the test results of 206 people and discovered that 57, or about 30 percent of them, had contracted HCV. Of the 57, 14 had suffered from chronic liver inflammation and cirrhosis and of these, five were found to have died.

Although the hospital has yet to obtain the test results of the remaining 300, it expects the number of HCV carriers to increase.

Unlike fibrinogen, which was often used to stop bleeding during obstetric procedures, fibrin glue, a mixture of fibrinogen and other substances, was not formally approved under the Pharmaceutical Affairs Law.

However, Green Cross, the defunct manufacturer of fibrinogen and the glue, marketed the glue regardless. The glue was widely used to stop bleeding and for sutures in cardiac, orthopedic and cerebral surgery.

By 1989, Green Cross knew that 19 people were highly likely to have been infected with HCV through the glue, but the pharmaceutical company falsely told the then Health and Welfare Ministry that it had found none.

The ministry failed to urge medical institutions to check on use of the glue and the potential spread of HCV contamination via the glue.

Through Welfide Corp., which was established after Green Cross was merged into another pharmaceutical company, the Health, Labor and Welfare Ministry later had medical institutions try to find out how the glue had been used. The ministry only received reports that about 48 of 3,297 patients, for whom the glue had been used, had contracted HCV.

Based on the report, the ministry estimated about 1,200 were likely to have been infected with the virus through the glue.

However, now that the 57 people have been discovered with HCV probably as a result of the glue's use at just one Tokyo hospital, the number of HCV sufferers likely to have contracted the virus through the glue is expected to rise significantly.

According to the ministry's estimates, of about 205,000 people who were given intravenous injections of fibrinogen as a hemostatic agent, 9,400 people have so far been reported to have contracted HCV through the blood product.

Of the 207 plaintiffs in the legal battle with the government and the pharmaceutical company, more than 170 said they were administered fibrinogen, but only two said the cause was fibrin glue.

So the number of people revealed to have been most likely infected with HCV through the glue will probably rise considerably.

A spokesman at the Tokyo hospital said: "[The glue] was commonly used in heart surgery. Closer and wider studies will likely reveal individual hospitals with several dozen patients who contracted HCV through the glue."

Source : www.yomiuri.co.jp

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