Hans Biomed said on Monday that its artificial breast implants are safe even after the Ministry of Food and Drug Safety recalled its product for using materials that differed from initially approved ones.

The regulator has ordered the recall of Hans Biomed's breast implants. (Hans Biomed)
The regulator has ordered the recall of Hans Biomed's breast implants. (Hans Biomed)

Stressing that it will be fully accountable for the violations that arose during the licensing process, the company said their product is not toxic and safe.

"We take full responsibility for causing concerns among our customers by the incident," the company said in an official statement, "We promise to become a company that fulfills its responsibilities by thoroughly investigating and improving related systems to prevent similar incidents from recurring in the future."

Despite its wrongdoings in the licensing process, the firm pointed out that an expert advisory meeting held by the Ministry of Food and Drug Safety, attended by plastic surgeons, polymer science and toxicology professors, had confirmed the safety of patients who underwent operation with the product.

The ministry's meeting concluded that the five raw materials that the firm had failed to list in the product permits are raw materials used in other implantable medical devices, and the possibility of leakage in normal conditions is very low. The committee also noted that although the risk for transplant patients is low, continuous monitoring of transplant patients was considered necessary, according to the company

"Even if the related product is safe, any illegal matters arising during the licensing process must be corrected, and we will take responsibility for such wrongdoings," the company said. "To prevent this from happening again, we will strengthen efforts to prevent its recurrence in the future, as well as reinforce the tracking management and compensation system for customers who use our products."

The company’ statement comes after the Ministry of Food and Drug Safety revealed last Friday that Hans Biomed had distributed about 70,000 of its silicone gel breast implants, Bellajel, manufactured using materials different from the those in product permits since 2015.

Based on such findings, the ministry ordered the suspension and recall of the artificial breast products and requested medical institutions to stop using the products through related organizations, such as the Korean Society of Plastic and Reconstructive Surgeons and Korea Medical Association.

The ministry also stressed that the company would be subject to administrative dispositions, such as suspension of business, for violations of the Medical Device Act.

It is collecting information on patients who underwent procedure with the product, provide safety information for them, and establish a communication channel. The regulators have also ordered Han Biomed to come up with a compensation plan for patients who received its breast implants.

Police are still investigating Hans Biomed regarding the use of toxic materials for manufacturing its products.

The company said it is actively cooperating with the police investigation, stressing that it is not true that the company's executives and employees have systematically conspired to conceal any wrongdoings.

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