People in Korea who have had breast augmentation surgery with Allergan's Biocell textured breast implants plan to file a lawsuit against the major breast implant manufacturer, after the health authorities recently confirmed the first case of rare cancer linked to the product here.
|Breast implants manufactured by Allergan / Captured from Allergan Korea website|
Nearly 3,000 people are registered as members of an online community through which the law firm is collecting participants. Lee said around 100 of them decided to join the lawsuit as of Monday and the number is expected to increase.
They include not only those who had breast augmentation for cosmetic purposes but also those who received the procedure after mastectomies due to breast cancer.
"Those participating in the lawsuit are seeking monetary compensation for the cost of removing the Allergan implants if they require a removal surgery, and for the psychological effects caused by fear of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)," Lee told The Korea Times.
The number of members increased after the Ministry of Food and Drug Safety (MFDS) and the Korea Society of Plastic and Reconstructive Surgeons announced Friday that they confirmed the first case of BIA-ALCL in a woman in her 40s, who had Allergan's Biocell textured implant.
Last month, the U.S. Food and Drug Administration (FDA) announced Allergan implants increase the risk of BIA-ALCL, and the company began to recall its textured breast implants and tissue expanders from the global market.
A Korean woman received breast augmentation surgery seven or eight years ago, and recently visited a hospital after one of her breasts became noticeably swollen. The doctor suspected BIA-ALCL and transferred her to a nearby university hospital, where the diagnosis was confirmed.
According to the ministry and the FDA, BIA-ALCL is not breast cancer itself, but it is a type of non-Hodkin's lymphoma, which is cancer of the immune system. It is found in the scar tissue and fluid near the implant in most cases, but it can spread throughout the body in some cases. The chance for an individual to have BIA-ALCL is considered low, but the cancer is serious and can lead to death if not treated promptly.
"Plastic surgeon groups in Korea as well as the U.S. FDA recommend patients not to have the Allergan implants removed if there are no symptoms such as persistent swelling or pain in the area of the breast implant," said Kim Hyun-ho, a deputy director of medical device safety bureau at the MFDS.
"Considering the side effects that a surgical procedure can cause, including postoperative hematoma and infection, surgeons in the U.S. and Europe do not recommend removing the implant when there is no symptom unless they are proven to have BIA-ALCL," Kim said.
However, if a woman who has had a breast augmentation feels abnormal pain or notices any swelling, they should visit doctor immediately, he said.
From April 2015 to June this year, 13,336 breast cancer patients underwent breast implant surgery and 5,763 of them, or 43.2 percent, had Allergan implants, according to data submitted to Rep. Choi Do-ja of the minor opposition Bareunmirae Party from the Health and Insurance Review and Assessment Service.
Data released by Rep.Nam In-soon of the ruling Democratic Party of Korea submitted by the drug safety ministry, showed there were 5,140 reports of side effects from breast implant surgeries from 2016 to 2018, and 1,389 of them were linked to Allergan's Biocell implant.