Fear is spreading among Korean women who received Allergan’s specific breast implant after news reports said those who used the company’s BIOCELL product were more likely to develop breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), rare cancer.

The users of the product are particularly questioning whether the local regulator promptly responded to the problem, especially after the health authorities confirmed the first case of BIA-ALCL in a patient who had Allergan’s breast implant.

The Ministry of Food and Drug Safety quickly recalled the product but failed to have the exact number of patients who had Allergan’s breast implants, critics said, adding that the ministry’s initial response was inadequate.

Yoo Hee-sang, director at the ministry’s Medical Devices Safety Evaluation Division, held a news conference on Tuesday to explain what the government will do to ensure the safety of patients with Allergan’s implants.

Yoo Hee-sang, director of the Medical Devices Safety Evaluation Division at the Food and Drug Safety Ministry, speaks during a meeting with reporters on Tuesday.

Question: Some critics said the ministry was not able to grasp the accurate number of patients.

Answer: We confirmed that about 110,000 Allergan breast implants were distributed. Physicians use one product for breast reconstruction, and two for plastic surgery. According to the guidance of the U.S. Food and Drug Administration, 20 percent of Allergan’s breast implants get removed eight years after the implant. Considering replacement during the years or a rupture in a transplant, we could not help but assume a rough number.

To know the exact number of patients, we are investigating the list of the medical institutions that received Allergan’s products. It is easy to track the breast reconstruction record because the data is stored via health insurance claims. In the case of plastic surgery, however, most of Allergan’s products were used in clinics, and many clinics have already shut down. This makes it challenging to know the exact number of patients.

Q: Korea reported the first case of rare cancer. Didn’t you have to prepare a measure in advance?

A: Since the issue of the association between a breast implant and BIA-ALCL was first raised in 2011, the government had a meeting with experts three times. Most of them said there would be no problem, and there was no case reported in Asia. Korea did not have any example of BIA-ALCL, either. Experts mostly said that scientific basis for causality and mechanisms of occurrence of the disease were unclear. So, we decided to enhance awareness and pathology exams rather than suspending the product sale. Since February when the authorities around the world were beginning to recall the product, we mandated physicians to receive the patient’s consent form that the patient had been notified of the product’s possible association with rare cancer.

Q: Exactly when did you order medical institutions to stop using Allergan’s breast implant?

A: After confirming the first case of BIA-ALCL on Aug. 14, we requested medical institutions to stop using Allergan’s product on Aug. 16 and ordered the sales suspension on Aug. 18. Before that, we noticed the FDA’s recommendation to recall the product on July 25 and immediately contacted Allergan Korea to recall the product in Korea. It was a voluntary recall, but the food and drug safety ministry had requested it first.

Q: Doctors do not recommend removing Allergan’s product if the patient has no problem. Why?

A: It is the same as in the U.S. and Europe. The decision was based on the comparison of risks of anesthesia, postoperative hematoma, inflammation, and infection in removal with the low possibility of developing BIA-ALCL. But as Koreans are worried, we plan to discuss the matter with oncologists and epidemiologists in depth. We will provide specific reasons why it is okay not to remove it so that the public can easily understand. We are setting up comprehensive measures.

Q: France and Canada have recalled not only Allergan products but other textured breast implants. What will the government do?

A: The U.S. recalled Allergan products only because they had a high incidence of BIA-ALCL among the users of Allergan products. In other countries, however, not only Allergan goods but other implants showed some rare cancer development. So, the food and drug safety ministry is to review recalling other products, too. This will be included in our comprehensive measures.

Q: Who is paying the cost for testing? How far have you discussed the issue with Allergan?

A: We ordered Allergan Korea to consult with the headquarters and report back their safety measures, including damage compensation for patients who received Allergan’s breast implants by the end of this month. We will see the measure and request an additional back up, if insufficient. We will keep demanding the right measures until local patients are satisfied. We also plan to do thorough monitoring until the issue is resolved.

Q: Aren’t breast implants subject to the government’s tracking as they are medical devices for human transplant?

A: Yes, they are. Most of the medical devices subject to the tracking, such as implantable cardiac pacemakers, are easy to follow because they are handled in large hospitals. Breast implants are managed at clinic levels and difficult to track down, however. Since November 2014, we ordered the company to identify the distribution path of the product every month. So, it is easy to track the products that were released since then. If we want to follow those distributed before that, however, we have to monitor the supply line, check the hospitals that received them, and offer our information to the hospitals.

Q: When do you plan to announce the measures?

A: We are devising up the measures as quickly as possible. Trust us and wait for a little bit more. We have ensured that no patient receives Allergan’s breast implant anymore, for now. I feel sorry for the patients who have already used the product. If possible, we will deliver the right information directly to the patients so that they can relieve their anxiety. We will help patients receive the diagnosis and explain well about testing procedures and methods. If side effects occur, the government will make every effort to ensure that the patients get full compensation. We will do our best to take quick measures.

lhs@docdocdoc.co.kr

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