Achilles Tendon Transplanted to 2,100 Patients... NHIS Files Complaints Against 8 Importers

[Asia Economy Reporter Kim Young-won] It has been confirmed that at least 2,100 patients received transplants of 'half-sized' Achilles tendons that were not approved for use by the authorities.

On the 17th, according to the National Health Insurance Service (NHIS), the NHIS identified circumstances in which Achilles tendons imported from a U.S. company were distributed domestically without approval from the Ministry of Food and Drug Safety (MFDS), and reported eight import companies to the police. The police are known to have started investigating the matter since February.

When approving the use of human tissues, the MFDS sets standards such as size, but the NHIS believes these companies distributed half-sized tendons smaller than the approved specifications without authorization.

Achilles tendons, which are mostly imported due to a shortage of domestic donors, are used when the knee's cruciate ligament is torn or when a severe injury requires transplantation. Some Achilles tendon transplant surgeries are covered by health insurance benefits. They are registered for coverage after review by the Human Tissue Specialized Evaluation Committee of the Health Insurance Review and Assessment Service.

The NHIS estimated that from 2015 over seven years, 7,600 Achilles tendons without MFDS approval were imported into the country, and excluding cases used in non-covered surgeries, at least 2,100 patients received 'half-sized Achilles tendons' in surgeries for which health insurance claims were made.

This estimate is based on examining only two of the eight companies reported by the NHIS, so the number could increase if cases used in non-covered surgeries are added or if further investigations into other companies proceed.

An NHIS official explained, "If a patient receives an Achilles tendon that does not meet the standards, the expected reconstruction effect is reduced, so there may be health issues for the patients who underwent surgery," adding, "Since there is evidence that improper health insurance funds were used for coverage, we have requested a police investigation."

This content was produced with the assistance of AI translation services.