"All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants." 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. 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 this disease that it was not possible to determine what factors increased the risk,” the agency said. Since then, "we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants," the FDA said in a statement March 21. 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. Over 350 Cases, 9 Deaths 
 
 The FDA notes that most data suggest that BIA-ALCL occurs more often after 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. 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. Of the 312 reports that included information on implant fill types, 186 described implants filled with silicone gel and 126, 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. The cancer can take about 10 years to develop on average after the implant first goes in and usually stays in the area right around the implant, WHO researchers reported last year in the journal Blood. 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. While the MDR system is a valuable source of information, it may contain incomplete, inaccurate, untimely, unverified, or biased data," the FDA says. During the last 6 years, a "significant body" of literature has been published on BIA-ALCL, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of the disease, the agency notes. Most of the cases reported in the literature describe individuals who have had textured implants. “Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation," it said. However, because BIA-ALCL 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," the FDA said. The American Society of Plastic Surgeons and the Plastic Surgery Foundation are making a list of implant patients who develop ALCL. 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. For now, the agency recommends that clinicians who have patients with breast implants take the following action: 
 
 Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast 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. Submit case reports of BIA-ALCL to the PROFILE Registry to contribute to a better understanding of the causes and treatments of BIA-ALCL. “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),” it says. Related: More Women Get Breast Implants Removed 
 
 “Although it is rare, breast-implant-associated ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants. Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants.” 
 
 The FDA has a breast implants website with more details. “If you have breast implants, there is no need to change your routine medical care and follow-up,” the agency added, noting that ALCL is rare. It’s usually diagnosed after a patient reports pain and swelling. 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. Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants,” the FDA advised. People with silicone gel implants should get magnetic resonance imaging (MRI) scans to look for leaks.
– Six years after first announcing a possible link between breast implants and a rare form of cancer, the FDA confirmed Tuesday that breast implants are connected to anaplastic large cell lymphoma, NBC News reports. In a statement, the FDA says women with breast implants "have a very low but increased risk" of ALCL. The FDA has received 359 reports of ALCL cases tied to breast implants, including nine people who've died from the cancer. ALCL appears to be more common in women whose implants have a textured—rather than smooth—surface, according to Medscape. Whether the implants are filled with saline or silicone gel doesn't appear to make a difference. ALCL takes an average of a decade to develop after the implant procedure. But it's easily treated if caught early, which typically happens when women start suffering pain and swelling. Most cases of ALCL have been treated by removing the breast implant. Some cases have required chemo and radiation. Breast implants are the second most popular cosmetic procedure for women. More than 300,000 breast implants were performed in 2015.