筆者經過考證之後,此淋巴癌的機率極低,與隆乳的相關性也待進一步的證實,所以請愛美的女性放心,不必太過憂慮,但是一旦隆乳後的胸部有異樣(如:遲發性的疼痛,異常腫脹,腫瘤產生,莢膜攣縮,不對稱),一定要趕快請妳的醫師幫妳檢查評估。


 


以下是國際美容外科醫學會寄給筆者的信(原文的相關訊息), 還有國內對此的相關報導。


Dear colleagues, 


On January 26, 2011 the American Health Authorities have released a safety signal on Anaplastic Large Cell Lymphoma (ALCL) in women with breast implants. 
Our colleagues in the American Society of Plastic Surgeons, chaired by their President Phillip Haeck, are working closely with the FDA to evaluate this issue further. 

Although the number of patients who developed the disease is extremely small (34 identified cases out of an estimated number of 5 to 10 million women with breast implants), we should inform our patients and follow the recommendations of the FDA closely: 


Recommended Actions for Health Care Providers and Patients 


Health Care Providers:

If you have patients with breast implants, you should continue to provide them routine care and support.  ALCL is a very rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.  Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.   

Current recommendations include the steps below.  As the FDA learns more about ALCL in patients with breast implants, these recommendations may change. 


·        Consider the possibility of ALCL when you have a patient with late onset, persistent peri-implant seroma.  In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If you have a patient with suspected ALCL, refer her to an appropriate specialist for evaluation.  When testing for ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out ALCL.  Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers. 


·        Report all confirmed cases of ALCL in women with breast implants to the FDA.  Link to how to report In some cases, the FDA may contact you for additional information.  The FDA will keep the identities of the reporter and the patient confidential.


·        Develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team.  Because of the small number of cases worldwide and variety of available treatment options, there is no single defined consensus treatment regimen. 


Patients: 

If you have breast implants, there is no need to change your 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, you should follow standard medical recommendations including: 


·        Monitoring your breast implants.  If you notice any changes, contact your health care provider promptly to schedule an appointment.  For more information on self breast exams, visit Medline Plus:  Breast Self Exam.


·        Getting routine mammography screening.


·        If you have silicone gel-filled breast implants, getting periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your health care provider.  The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter. 


If you do not currently have breast implants but are considering breast implant surgery, discuss the risks and benefits with your health care provider.  You may also visit FDA’s Breast Implants website for additional information. 

  Please inform us if one of your patients develops ALCL or will develop in the future. Please send the information to us first in order to avoid double reporting. We are going to forward your information to ASPS and FDA accordingly.  

  Please do not hesitate to approach us if you have questions or if you need our support. 

  For sure there is no reason to get into a panic but we need to be proactive and inform our patients and the media in a well balanced fashion. 


Sincerely yours 



Marita Eisenmann-Klein                             Zacharias Kaplanidis
IPRAS General Secretary                               IPRAS Executive Director


LINKS:


-American Society of Plastic Surgeons to MOU Partners, letter Phillip C. Haeck, President ASPS, Statement Philipp Haeck, “FDA to issue safety signal on ALCL & breast implants”



-Plastic Surgery News, Special Bulletin, January 26, 2011



-FDA Medical Device Safety Communication: Report of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants (Clean Version)


-Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants:”Preliminary FDA Findings and Analyses” (White Paper Clean Version)




====================================================



美FDA:隆乳女性 罹罕見淋巴癌風險增


中時 更新日期:2011/01/28 03:06 鍾玉玨/綜合報導



中國時報【鍾玉玨/綜合報導】



美國「食品暨藥物管理局」(FDA)廿六日警告,接受生理食鹽水或矽膠填充物隆乳的女性,填充物周遭出現「異生性大細胞淋巴瘤」(anaplastic large cell lymphoma,ALCL)的機率可能微幅增加。



ALCL屬罕見的免疫系統癌症,在美國,無隆乳女性罹患的機率微乎其微,約億分之三。而全球約五百萬至一千萬隆乳婦女中,迄今已確診罹患ALCL者約六十例,比例也還算低。



FDA建議,若隆乳女性出現胸部腫脹、持續疼痛,甚至兩邊胸部不對稱的症狀,須儘快就醫。整體而言,FDA認為填充物無安全之虞,沒有症狀的女性無須將填充物取出,但需定期追蹤。



FDA首席科學家梅塞爾稱,目前數據不足以證實隆乳填充物與ALCL有直接關連,加上某些病例可能重複通報,故需更多數據佐證。矽膠隆乳長期存在爭議,不少矽膠隆乳患者抱怨填充物滲漏,因此美國一九九二年起一度禁止矽膠隆乳,但二○○六年又重新批准。



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