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Japan pericardium importer took months to warn hospitals.

TOKYO, Aug. 29 Kyodo

A Tokyo-based importer of U.S.-made artificial pericardiums linked to inflammation in transplant patients waited six months before warning hospitals after it learned of health risks associated with the product, medical sources said Monday.

Jastra Japan Co., which imports the pericardiums from Shellhigh Inc. of the United States, learned in June last year that pus discharge had leaked from the wounds of transplant patients at a hospital in eastern Japan, the sources said.

Artificial pericardiums, produced from cow and horse tissue and artificial fibers, are used in heart operations due to the difficulty of closing a patient's pericardium following surgery.

Jastra confirmed the safety of the product after making inquiries with a U.S. medical manufacturer, but in late December, it told hospitals to refrain from using the pericardiums. It began recalling the products in February this year, the sources said.

The recall came six months after another hospital complained about the pericardiums, saying recipients suffered mediastinitis, an inflammation of the space between the lungs that contains the heart.

The Health and Welfare Ministry ordered Jastra to gather information on the pericardiums from hospitals that had used the product after the complaint was made in August.

According to a ministry survey released Monday, 62 recipients of pericardiums suffered mediastinitis. An estimated 700 to 1,000 patients are believed to have received the substitute pericardiums at about 40 hospitals across Japan, according to the sources.

While the importer kept mum about health risks associated with the product, a hospital in northeastern Japan began using them in June last year. Of roughly 70 patients who received them at the hospital between June and December last year, 15 developed mediastinitis, the sources said.

The pericardiums were removed from the 15 patients, who no longer suffer symptoms, they added.

A third of the 62 patients reported by the ministry are believed to have developed symptoms after receiving the pericardiums in June last year or later, according to the sources.

Jastra officials defended their decision, saying they had little information about product problems in June last year and could not have persuaded hospitals not to use them at the time.
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Publication:Japan Weekly Monitor
Date:Sep 4, 2000
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