Breast implants may cause a small but significant increase in the risk of an extremely rare but treatable type of cancer , the Food and Drug Administration said on Wednesday. 
 
 The risk applies to both saline- and silicone-filled implants, and to all women who have them, whether for reconstruction after cancer surgery or for cosmetic enlargement of the breasts. 
 
 The cancer, anaplastic large-cell lymphoma, involves the immune system. It is not breast cancer. It is usually a systemic disease, but in the cases linked to implants, the lymphoma grew in the breast, usually in the capsule of scar tissue that formed around the implant. The cases were discovered because women developed symptoms long after they had healed from the implant surgery — lumps, pain, asymmetry of the breasts, fluid buildup and swelling. 
 
 In some cases simply removing the implant and scar tissue gets rid of the disease, but some women might need chemotherapy and radiation, said Dr. William Maisel, the chief scientist and deputy director for science in the drug agency’s Center for Devices and Radiological Health. He said there was some evidence, though not conclusive, that the form of this lymphoma found in implant patients was less aggressive than the usual type. 
 
 So far, the drug agency said it knew of about 60 cases worldwide, a tiny number compared with the 5 million to 10 million women who have implants. But even that small number appears to be an excess of cases when compared with the usual incidence of the disease: This type of lymphoma in the breast is normally found in only 3 in 100 million women who do not have implants. 
 
 Because the risk appears to be so small, the drug agency said, “the existing data support the continued marketing and use of breast implants.” But it also said that women considering implants should first discuss the information with their doctors. 
 
 Women with implants who have no symptoms do not need to do anything special or change their routine health care, Dr. Maisel said. But they should pay attention to any changes and see a doctor if swelling, lumps or other symptoms develop. 
 
 Because there is very little data on the lymphoma, Dr. Maisel said, the agency “is not comfortable recommending a specific treatment.” Cases may differ, and women who have the disease need to be treated by a breast surgeon and an oncologist. 
 
 The worldwide market for breast implants is roughly $820 million a year and growing at 8 percent a year, according to industry figures. 
 
 The Food and Drug Administration said it needed more data and was asking doctors to report confirmed cases to its safety information program, MedWatch. Dr. Maisel said the agency was working with the American Society of Plastic Surgeons to create a registry of cases. He also said that information about the possible link to the cancer would be added to the labeling information sent out with implants. 
 
 Dr. Maisel said it was not yet known for sure whether the implants really increase the risk of the cancer, or how they could do so. 
 
 “We do know that both silicone and saline implants are surrounded by silicone,” he said, adding that silicone has been found in cells around breast implants and may stimulate the cells and induce lymphoma in rare cases. But he added, “Please understand that is speculative and a hypothesis.” 
 
 A spokeswoman for Allergan, which makes implants, sent a statement by e-mail saying that the company supported the drug agency’s recommendations. But the statement also said: “Reports of ALCL in patients with breast implants are extremely rare and are not to be mistaken for breast cancer. A woman is more likely to be struck by lightning than get this condition.” 
 
 Another implant maker, Mentor, did not respond to a telephone message asking for comment on the drug agency announcement. 
 
 A medical group, the American Society for Aesthetic Plastic Surgery, issued a statement saying it supported the development of a registry for the cancer cases in women with implants, but added that implants were “the most studied device in medical history” and were safe. ||||| Individuals with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. Precise risks are difficult to determine due to lack of information about how many patients have received breast implants in the US and worldwide. 
 
 Background 
 
 In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL). 
 
 At that time, the FDA knew of so few cases of ALCL that it was not possible to determine what factors increased a patient’s risk. In a report summarizing the Agency's findings, we emphasized the need to gather additional information to better characterize ALCL in individuals (cis- and trans-gender women and men) with breast implants. 
 
 Over time, we have strengthened our understanding of this condition. In 2016, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global breast implant sales data. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces. 
 
 FDA Actions 
 
 We continue to collect and evaluate information about ALCL in individuals with breast implants. 
 
 On an ongoing basis, we: 
 
 
 
 Current Status 
 
 Since 2016, there have been several advances in the description of the disease and treatment recommendations. These are summarized below: 
 
 The World Health Organization recognized breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a unique form of ALCL that can develop following breast implant, implantation. 
 
 recognized breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a unique form of ALCL that can develop following breast implant, implantation. Professional organizations including the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) published information to help physicians understand the disease and provide diagnosis and treatment. 
 
 and the National Comprehensive Cancer Network (NCCN) published information to help physicians understand the disease and provide diagnosis and treatment. Regulatory bodies outside the United States issued communications on BIA-ALCL. The Australian Therapeutic Goods Administration (TGA) reported a detailed analysis of the 46 patients with confirmed cases of BIA-ALCL in Australia, including the deaths of 3 women. As of September 2016, TGA has confirmed 10 additional cases in Australian patients. The French National Agency for Medicines and Health Products Safety (ANSM) asked manufacturers of textured breast implants to perform biocompatibility testing (testing to determine how living tissues react to textured implants) and to report their findings. 
 
 
 
 Medical Device Reports 
 
 As of September 30, 2017, the FDA had received a total of 414 medical device reports (MDRs) of BIA-ALCL, including the death of nine patients. 
 
 272 of the 414 reports included information on the surface information of the implant at the time of the report, including 242 with textured surfaces and 30 with smooth surfaces. 413 of the 414 reports included information on implant fill types. Of these, 234 reported implants filled with silicone gel and 179 reported implants filled with saline. While the MDR reports provide information regarding the implant at the time of BIA-ALCL diagnosis, they do not typically give information about a patient’s history of breast implants. In the MDR reports, half of the reported cases were diagnosed within 7-8 years of implantation. It is important to note that at the time of diagnosis, patients may have their original breast implants or they may have had one or more replacements. 
 
 The MDR system is a valuable source of information. However, it depends on accurate reporting, and therefore may contain incomplete, inaccurate, untimely, unverified, or biased data. Over time, we may gather more information about a report and thus the numbers listed above may change. 
 
 In addition, it is difficult to determine the total number of cases or estimate risk from the MDR reporting system due to potential under-reporting of events, possible duplicate reporting, and lack of data about the exact number of breast implants. 
 
 Medical Literature 
 
 A significant body of medical literature has been published since our 2011 report, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of the disease. Most of the cases reported in the literature describe individuals who have had textured implants. Several recent journal articles explore possible risk factors for developing BIA-ALCL, including the methods used to create the textured surface and the role of biofilm. Most of the published information about treatment describes removal of the implant and the capsule surrounding the implant, and in some patients, treatment with chemotherapy and radiation. 
 
 Several recent publications have estimated the risk of developing BIA-ALCL in individuals with textured breast implants. Current literature reported various estimates that BIA-ALCL may develop in 1 in between 3,817 to 30,000 women with textured breast implants (Clemens et al, 2017; Loch-Wilkinson et al, 2017 ; De Boer et al, 2018). 
 
 Recommendations 
 
 Health Care Providers: 
 
 If you have patients with breast implants, you should continue to provide them routine care and support. BIA-ALCL has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma (fluid collection around the implant). Based on the available literature, half of the reported cases were diagnosed within 7-8 years post-implantation. Because BIA-ALCL has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or breast asymmetry, prophylactic breast implant removal in patients without signs or symptoms is not recommended. 
 
 Current recommendations from the Plastic Surgery Foundation and the NCCN include the steps below. 
 
 Provide all patients with the breast implant manufacturer’s labeling as well as other educational material prior to implantation, and make sure they are aware of the benefits and risks of the different types of implants. Most confirmed cases of BIA-ALCL have occurred in women with textured surface implants. 
 
 Consider the possibility of BIA-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 BIA-ALCL, refer the individual’s case to a multidisciplinary tumor board for evaluation. 
 
 When testing for BIA-ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-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. 
 
 Develop an individualized treatment plan in coordination with the patient's multi-disciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach. 
 
 Report all confirmed cases of ALCL in individuals with breast implants to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential. 
 
 Submit case reports of BIA-ALCL to the PROFILE Registry to contribute to a better understanding of the causes and treatments of BIA-ALCL. 
 
 Patients: 
 
 Educate yourself about breast implants before agreeing to surgery. Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells). Additional information is available on FDA's Breast Implants website. 
 
 BIA-ALCL appears to develop more frequently in individuals with textured implants than in people with smooth-surfaced implants. Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of both textured-surface and smooth-surfaced implants. 
 
 If you have breast implants, there is no need to change your routine medical care and follow-up. You should expect swelling and pain immediately after surgery. If you notice changes in the way your breast looks or feels after you recover from surgery—including swelling or pain around the implant—be sure to talk to your health care provider about the possibility of BIA-ALCL. 
 
 
 
 Although not specific to BIA-ALCL, you should follow standard medical recommendations including: 
 
 Follow your doctor's instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. 
 
 Follow your doctor’s instructions for routine mammography screening. Be sure to inform the mammography facility that you have breast implants so enough time is scheduled for your mammogram. Your doctor may also recommend other tests, such as magnetic resonance imaging (MRI). 
 
 To improve our understanding of BIA-ALCL, please continue to report all confirmed cases of BIA-ALCL, with as much detail as possible, through FDA's MedWatch Program. 
 
 We will continue to report on significant findings as new information and analyses become available. 
 
 Related Information
– Breast implants have been linked to an extremely rare but treatable cancer, the New York Times reports. It's called anaplastic large-cell lymphoma, and in these cases, it usually forms in the scar tissue around the implant. The link was seen in saline and silicone implants, and in both reconstructive implants for breast cancer sufferers and in cosmetic surgeries. The good news: Only about 60 cases have been reported worldwide—out of 5 million to 10 million women with implants. Given the rarity of the condition, the FDA said implants are still safe, though women considering them should factor it into their decision. One manufacturer of implants said "a woman is more likely to be struck by lightning than get this condition.” Most women diagnosed reported symptoms—including lumps, fluid buildup, pain, and swelling—long after they had healed from surgery. (Click for other health risks associated with implants.)