2010-2025 Form

There are a few important things to note here that are evident if you read the FDA alert (which you can find here - Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) - Letter to Health Care Providers)First, it appears based on data cited in the report that the percentage of impacted patients is somewhere between 0.026% and 0.003% of patients with breast implants. That puts this in the world of ‘Yes, it happens, but it’s somewhere between rare and really rare.’Second, while there have been studies and reports dating back several years, the specific studies that the FDA cited were published relatively recently (2017 and 2018.) The FDA last report on this, in 2011 included the following:One possible exception is the rare development of Anaplastic Large Cell Lymphoma (ALCL) in 28 women with breast implants. Reports in the scientific community have suggested a possible association between ALK-negative ALCL and silicone gel-filled and saline-filled breast implants. In a thorough review of scientific literature published from January 1997 through May 2010, the FDA identified 34 unique cases of ALCL in women with breast implants throughout the world. The FDA’s adverse event reporting systems also contain 17 reports of ALCL in women with breast implants. Additional cases have been identified through the FDA’s contact with other regulatory authorities, scientific experts, and breast implant manufacturers. In total, the FDA is aware of approximately 60 case reports of ALCL in women with breast implants worldwide. [1]60 cases world wide is a pretty small sample set.The recent studies provided more information, more data, more cases, and were (likely) sufficiently compelling for the FDA to look back at their own collection of reports. This time around, “The FDA's additional data analysis identified 457 unique MDRs for BIA-ALCL, including the death of nine patients which may be attributable to BIA-ALCL.”[2]So, in 2011 when they published their report on implant safety, they had 60 cases. Now, following studies released in 2017 and 2018, they have 457 cases. That’s more, and prompted the FDA’s new guidance.The two most relevant parts of the FDA guidance are these:Consider the possibility of BIA-ALCL when treating a patient with late onset, peri-implant seroma. In some cases, patients presented with a mass or masses adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer the individual's case to a multidisciplinary team for evaluation.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 or mass with Wright Giemsa stained smears and cell block immunohistochemistry/flow cytometry testing for cluster of differentiation (CD30) and Anaplastic Lymphoma Kinase (ALK) markers.[3]Translation - Hey providers, if you see this symptom set, collect a sample and consider that this might be a thing.Cool. Useful to let providers know. Here’s a thing you might see in patients with this kind of medical device and this set of post-operative symptoms. Good on the FDA for recommending specific testing for providers.That’s it. In the grand scheme of things, this isn’t earth shattering. It’s a minor update to clinical practice based on a few years worth of additional data collection. The FDA has also alerted providers to report further cases. If it turns out more serious action is required based on that additional data, I expect the FDA to take appropriate steps.For the rest of us including people like me with textured implants? If I notice this symptom set, I’m informed and can talk to my doctor about it. Otherwise? It happens in between 1 in 3,800 and 1 in 30,000 patients. That’s higher odds than the chance of being struck by lightning (1 in 700,000) but it’s about on par with the odds of being hit by a car / or being killed by a car… Yeah, I look both ways before I cross the street and I wait at cross walks but I don’t stay off the roads. I’ll keep having regular checkups, mammograms and MRIs at the recommended frequency but I’m not scared that my implants will give me cancer or kill me.Context and perspective are everything.Footnotes[1] https://www.fda.gov/downloads/me...[2] Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) - Letter to Health Care Providers[3] Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) - Letter to Health Care Providers

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