美FDA '실리콘 유방' 희귀암 주의보 국내에서 유방성형 사례가 급증하고 있는 가운데 미국 식품의약국(FDA)이 최근 실리콘을 사용한 유방성형 보형물이 암을 유발할 수 있다고 경고하고 나섰다.
실리콘 막에 식염수를 채우거나 겔 형태의 실리콘을 사용한 모든 제품이 경고 대상이다.
식품의약품안전청도 즉각 국내 관련 의료기관에 주의를 당부하는 서한을 배포했다.
7일 식약청에 따르면 FDA는 실리콘 막 및 실리콘 겔 형태의 인공유방 시술 후 몸속 인공유방과 맞붙은 흉터 막에서 드물지만 '역형성대세포림프종'(ALCL)이 발생할 위험이 있다고 발표했다.
ALCL은 면역체계 이상으로 발생하는 희귀암으로, 몸속 면역기관인 림프절과 피부 등 다양한 부위에서 발병하는 것으로 알려져 있으며 예후도 불량한 암종이다.
FDA는 홈페이지에 게시한 발표문에서 '전 세계적으로 인공유방을 삽입한 여성 중 60명이 이 병에 걸린 것으로 집계됐다.'고 전했다.
이에따라 식약청은 성형 전문의 등 의료인들에게 안전성 서한을 배포, 인공유방 시술을 받으려는 여성들에게는 미리 이 같은 위해성을 알려 주도록 권고했다.
또 인공유방 이식 후 시술 부위에 장액종(수술 부위에 물이 고이는 현상)이 생기면 즉시 ALCL 발병여부를 확인하도록 요청했다.
인공유방 제품 수입 및 제조업체에도 사용상 주의사항에 '보형물에 인접한 흉터 막에 경미하지만 유의미한 ALCL 발생 위험이 있음'이라는 문구를 추가하도록 했다.
실제 발병 사례가 있음녀 식약청에 보고해 줄 것도 당부했다.
국내에서는 아직까지 인공유방 시술 후 ALCL 발병이 보고된 사계는 없다.
하지만 해마다 인공유방용 실리콘 제품을 2만~3만개나 수입하고 있는 점을 감안하면 아픙로 환자가 발병할 가능성이 높다는 것이 전문의들의 견해다.
이와 관련, 식약청은 "미국에서 인공유방과 무관하게 매년여성 50만명 중 1명이 ALCL 확진을 받을만큼 희귀한 질환이기 때문에 인공유방 시술을 받은 여성들이 정기 및 추적검사를 변경할 필요는 없다." 면서 "그러나 인공유방을 삽입한 사람은 지속적으로 시술 부위를 관찰해야 하며, 이상 변화가 감지되면 지체 없이 의료진과 상의해야 한다."고 강조했다.
FDA NEWS RELEASE
For Immediate Release: Jan. 26, 2011
Media Inquiries: Erica Jefferson, 301-796-4988,
erica.jefferson@fda.hhs.govConsumer Inquiries: 888-INFO-FDA
FDA review indicates possible association between breast implants and a rare cancer
Agency requesting health care professionals to report confirmed cases
The U.S. Food and Drug Administration today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.
The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.
In an effort to ensure that patients receiving breast implants are informed of the possible risk, FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.
“We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA’s Center for Devices and Radiological Health. “We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants.”
According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.
In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants.
The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.
Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis.
The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:
- Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.
- Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
- There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, health care providers should follow standard medical recommendations.
- Women should monitor their breast implants and contact their doctor if they notice any changes.
- Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.
The FDA published its literature review in a document posted on FDA’s website site today titled “Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses.”
The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.
