The U.S. Food and Drug Administration is asking health care professionals to report any confirmed cases of anaplastic large cell lymphoma (ALCL) in women with silicone gel- or saline-filled breast implants, citing concerns about a possible association.
The agency’s announcement during a teleconference on Jan. 26 is based on a review of scientific literature published between 1997 and 2010, along with information from other international regulators, scientists, and breast implant manufacturers.
“ALCL is rare and has occurred in a very small number of women when compared to the millions who have breast implants,” said Dr. William Maisel, chief scientist and deputy director for science in FDA’s Center for Devices and Radiological Health. The literature review identified 34 unique cases of this rare cancer in women with both saline and silicone breast implants. There have been roughly 60 cases of ALCL in women with breast implants worldwide, according to the FDA. It’s estimated that 5-10 million women have breast implants worldwide.
“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 agency noted in a press release. Most of the cases reviewed by the agency were diagnosed when patients sought treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry.
The FDA recommends that health care professionals consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). When implant seroma is found, fresh seroma fluid should be sent for pathology tests to rule out ALCL. Patient information about breast implants and ALCL can be found in the FDA’s Consumer Updates.
Health care providers should discuss the risks and benefits with women who are considering breast implant surgery. The FDA published its literature review in a document posted on its Web 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.
Health care professionals should report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program, either online or by calling 800-332-1088.
The FDA also provides general information about breast implants to share with patients.
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1月26日，美国食品药品管理局(FDA)在其官网发表《间变性大细胞淋巴瘤与乳房假体：FDA的初步发现与分析》(Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses)，该文对1997~2010年间发表的文献及一些国际监管机构、科学家和乳房假体生产商提供的信息进行回顾发现，硅凝胶或生理盐水填充的乳房假体可能与间变性大细胞淋巴瘤(ALCL)有关。
此次回顾共在生理盐水和硅凝胶假体隆胸女性中发现34例ALCL。据估计，世界范围内约有5百万至1千万名女性进行隆胸，目前已发现约60例ALCL。所回顾的资料表明，ALCL见于假体附近瘢痕胶囊的可能性很小但值得密切关注。大部分ALCL病例是在因假体相关症状(如疼痛、肿块、肿胀或不对称)就诊时获得诊断的。
FDA表示，如患者假体周围迟发持续皮下积液，则应考虑ALCL的可能。一旦发现假体皮下积液，应采集积液进行病理检查以排除ALCL。医生应与考虑隆胸的女性讨论手术的风险和收益，并应将所有确诊的ALCL病例上报至FDA的Medwatch。FDA计划在2011年春季对该篇文献回顾进行更新。有关乳房假体和ALCL的患者信息参见FDA的消费者更新资料及隆胸手术患者须知。
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