The compensation program for artificial hip joints (ASR made by DePuy), which were recalled because they melt inside the body, will be extended in part depending on the occurrence of the side effect.

The Ministry of Food and Drug Safety (MFDS)_{식품의약품안전처} and Johnson & Johnson Medical Korea_{한국존슨앤존슨메디컬} announced Wednesday changes in the compensation program for the artificial hip joint.

According to the announcement, patients who got an artificial hip joint transplant with ASR made by DePuy from October 2006 to August 2010 can get full compensation for all costs, such as checkup fees and incidental expenses incurred until Aug. 24. Even though the patients have not suffered from side effects, they can receive compensation for testing charges and treatment costs.

Patients need to check the occurrence of side effects through examination until Aug. 24, even though they don’t have bad side effects now.

Patients who have side effects due to the artificial hip joint, however, they will be able to get compensation even after Aug. 24 because the reoperations resulting from recalls within 10 years of transplants are included in compensable categories. The compensations include reoperation costs and incidental expenses such as checkup fees and treatment costs for one year after the reoperation.

However, Johnson & Johnson Medical Korea will examine whether they are related to recalls or subject for compensation case by case.

The ASR artificial hip joints imported and sold by Johnson & Johnson Medical Korea were recalled in the United States and Korea as they caused the problem of melting inside the body.

A total of 321 Koreans got the artificial hip joint transplant, and 255 of them have registered for the compensation program as of Thursday.

Out of the 66 unregistered patients, 21 have died, and 12 refused registration. Nine patients could not be reachable to notify the compensation programs – three are foreigners and six others with unknown residence. The rest have been informed of the compensability but failed to register without making replies, according to the ministry.

“The government, along with Johnson & Johnson Medical Korea, has decided to announce the compensation program once again because many patients misunderstand it ends after Aug. 24,” said Yoo Hee-sang_유희상, director of the ministry’s Medical Devices Safety Evaluation Division. “Patients who receive treatments or undergo reoperation related to recalls can continue to receive compensation. However, the payment of treatment costs for patients who didn’t suffer from side effect ends on Aug. 24, so we have had to announce it again as active follow-up measures.”

The ministry said it plans to cooperate closely with Johnson & Johnson to dispel misunderstanding about the compensation program.

“Not all patients who got transplants with the product in question have the bad side effects,” Yoo said. “However, the ministry has told as many patients as possible to participate in the compensation program during the remaining one month, and will ask the company to make detailed explanations about the compensation program to reduce misunderstanding.”

lhs@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>