By Patrick O'Brien, JD, Legal Coordinator, American Med Spa Association

HansBiomed, a South Korea-based medical device and biologics manufacturer, has been fined and ordered to halt the production of some products for six months by the South Korean Ministry of Food and Drug Safety (MFDS). The MFDS is similar in purpose to the U.S. Food and Drug Administration (FDA)—it regulates and approve drugs and medical devices, and it has the power to investigate and impose penalties for violations. HansBiomed is the manufacturer of Mint Lift brand PDO threads and the BellaGel line of breast implants; the company's breast implants were the subject of the investigation that led to this penalty.

What Is This About?

The investigation stems from a whistleblower report from late 2019. In November 2020, the MFDS found that HansBiomed had failed to disclose five of the raw materials used in the manufacturing process for BellaGel implants on its approval application. The MFDS's expert advisory meeting found that the five materials are used in other implantable devices with a low risk of leakage and that they do not pose a safety risk to patients who already have the implants. The MFDS ordered a recall on the breast implants and a suspension of their use in Korea, with an administrative penalty to follow.

What Is the Penalty?

The penalty was announced on January 5, 2021—it orders a halt to all manufacturing starting on January 15 and continuing for six months for most of the company's products, and between seven and seven-and-a-half months for others. Four products, including the company's PDO threads, were exempted from the manufacturing ban and instead were covered by a fine of $761,000. A company spokesperson has indicated that HansBiomed intends to challenge the penalty.

What Does This Mean for My Medical Spa?

The impact for U.S.-based medical spas that carry HansBiomed products will likely be minimal. HansBiomed is still able to manufacture its PDO thread product lines during the suspension. Further, it is also able to sell its supply of already-manufactured products. The company has stated that it will increase production prior to the January 15 deadline to reduce any impact on supply as much as possible. (The manufacturing suspension is a penalty for the registration violation and not due to any safety issues with the products.) Additionally, the FDA, which has jurisdiction here, has so far not issued any citations or advisories to HansBiomed. We will be monitoring this situation and keep you informed of new developments.