Artificial breast implant’ safety issue has arisen once again, as the police have started an investigation into Hans Biomed's Bellajel for allegedly using toxic materials for manufacturing its products.
The investigation has caught the attention of both the medical and patient community as it has been about a year since the Ministry of Food and Drug Safety revoked the sales license for Allergan's breast implant due to the possible side effects of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) in patients who received Allergan's breast implants in August of last year.
According to Hans Biomed, the South Gyeonggi Province Police Agency raided the company’s offices in Seoul and Daejeon, questioning its present and former executives and employees who raised suspicions.
The substance in question is the implant's raw silicon material -- Dow Corning's 7-9700 and Q7-4850. Some claim that the substances are unsuitable raw materials for manufacturing breast implants, but the company has flatly denied such allegations.
The Korea Occupational Safety & Health Agency (KOSHA) said that the substance is harmful to humans at high temperatures. Dow Corning also stated that the product is not designed or intended to implant any duration in the human body.
However, Hans Biomed alleged that it only becomes a problem when used as a raw material. The company further stressed that a product's biological safety evaluation test should be based on the finished product and not the raw material. It added that Bellajel had conducted preclinical trials to confirm the product's safety, while follow-up clinical trials are also ongoing after approval.
The firm stressed that the police's investigation is about the report's difference during approval and not the product's safety.
"We are aware that there are errors in some of the approval filing for our products," the firm said. "Therefore, we are actively cooperating with the police investigation. Despite the concerns raised, the company has various research data that can prove its stability and the materials used in the product.”
The company also stressed that it is not true the company's executives and employees have systematically conspired to conceal any wrongdoings.
"We are a company that has steadily grown for 20 years and has been able to make products that are recognized not only in Korea but in the rest of the world," the company said. "We place top priority on stability in all of our products."
The Korean Society of Plastic and Reconstructive Surgeons said that they are paying close attention to the matter.
"As the matter at hand is about the safety of the raw material and is not related to manufacturing or licensing, it is too early for us to comment," an association spokesperson told Korea Biomedical Review. "As the police investigation is still underway, we are keeping a close eye as it may lead to patients needing to remove their breast implants."