BIA-ALCL Implant related lymphoma

Sharon , the FDA first reported ALCL in 2011 when very little was known of the problem. In 2014 I stumbled onto ALC being rarely found in implants as cited by the FDA in 2011 report. The in Mar. 2017 the FDA updated the risks were 6 times higher in textured implants,but at the same time the FDA reported, "the risk of BIA-ALCL diagnosis is quite rare: out of 100 million women, it's estimated that only 3 cases would be diagnosed in a year." I feel this risk estimate was misleading and confusing as it did not say whether or not the 100 million women were women with textured implants, smooth. If you do the math the risk for textured implants, being its 6 time higher, as stated in the 2017 FDA report, actually out of 16.7 million women with textured implants, 3 cases would be diagnosed or 1 out of 5.5 million women with textured implants. Okay, I doubt few women did the math and many women with textured implants were mislead, including me. Nonetheless, the risks for ALCL were still pretty small, even after doing the math. Then these risks were updated in Mar 2018 to be quite different at a risk of "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). According to the FDA footnote, Clemens documents:

The current lifetime risk of BIA-ALCL is estimated to be 1:3817 - 1:30,000 women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades. Certain geographic locations have demonstrated variable risks. For instance, a December 2016 update from the Therapeutic Goods Administration of Australia and New Zealand reported a risk of 1:1,000 to 1:10,000 for textured implants. Researchers in Netherlands recently found a risk of 1:6900 women with textured implants, and a report by Health Canada has found a risk of 1:24000 women with textured implants based upon 5 cases reported to government authorities. These discrepancies may represent variable reporting or may represent geographic and genetic predisposition which is under investigation.

Notice the Clemens resource does specify the study group is for textured implants, finally! Why the geographic differences exits are beyond my understanding. All of these different risk estimates can be confusing to say the least. I just hope the FDA comes forward with solid UNWAVERING information soon, maybe by the March 2019 meeting in Silver Springs, MD, which I intend to go to. Godspeed to us all in the textured implant boat.

Sharon , the FDA first reported ALCL in 2011 when very little was known of the problem. In 2014 I stumbled onto ALC being rarely found in implants as cited by the FDA in 2011 report. The in Mar. 2017 the FDA updated the risks were 6 times higher in textured implants,but at the same time the FDA reported, "the risk of BIA-ALCL diagnosis is quite rare: out of 100 million women, it's estimated that only 3 cases would be diagnosed in a year." I feel this risk estimate was misleading and confusing as it did not say whether or not the 100 million women were women with textured implants, smooth. If you do the math the risk for textured implants, being its 6 time higher, as stated in the 2017 FDA report, actually out of 16.7 million women with textured implants, 3 cases would be diagnosed or 1 out of 5.5 million women with textured implants. Okay, I doubt few women did the math and many women with textured implants were mislead, including me. Nonetheless, the risks for ALCL were still pretty small, even after doing the math. Then these risks were updated in Mar 2018 to be quite different at a risk of "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). According to the FDA footnote, Clemens documents:

The current lifetime risk of BIA-ALCL is estimated to be 1:3817 - 1:30,000 women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades. Certain geographic locations have demonstrated variable risks. For instance, a December 2016 update from the Therapeutic Goods Administration of Australia and New Zealand reported a risk of 1:1,000 to 1:10,000 for textured implants. Researchers in Netherlands recently found a risk of 1:6900 women with textured implants, and a report by Health Canada has found a risk of 1:24000 women with textured implants based upon 5 cases reported to government authorities. These discrepancies may represent variable reporting or may represent geographic and genetic predisposition which is under investigation.

Notice the Clemens resource does specify the study group is for textured implants, finally! Why the geographic differences exits are beyond my understanding. All of these different risk estimates can be confusing to say the least. I just hope the FDA comes forward with solid UNWAVERING information soon, maybe by the March 2019 meeting in Silver Springs, MD, which I intend to go to. Godspeed to us all in the textured implant boat.

Your link here is not working, Jamee.

FYI-Jamee-You are highly helpful with the multiple ALCL posts since 2017, which are insightful and outstanding. What would I do without you as you have broaden my knowledge concerning ALCL that otherwise would have taken me days to research and digest. Many, many thanks!

Racheal

hi all

called my PS office as I do have Allegan textured implants - not sure of any other info.  They have given me an appointment for a consult in 2 weeks which is pretty unheard of since it normally takes 4-6 months to see them.  She said my PS would discuss options with me? 

I honestly don't understand all the stats but I did do some research and in Europe their license to sell these has not been approved do to health risk

pretty sobering 

I am beyond happy to say that my pathology came back benign! I just had my Allergan 410s removed last week, with total capsulectomy. Finding out it was negative the day before my 45 birthday was the best birthday gift ever. I'm anxious to see what the FDA will determine next week at their meeting. Hopefully they will follow suit with Europe, and pull all textured implants from the US market.

I had them replaced with round, smooth, highly cohesive gel implants. The same level of cohesiveness as the 410s, but not anatomically shaped and textured.

This is my path report. Can someone experienced in this tell me if something is glaringly missing? If they need to look for something else or run different tests, I can ask them to redo. Thanks

Did they do CD30 testing for screening ALCL? CD 30 tests with 85% accuracy (check article below for the exact number). The bottom line is that some women with negative fluid tests and have positive ACLC capsules that too can be tested via CD30, so even if you test negative you may want to consider explant and complete capsulectomy, which you had. Read reference here for false negative CD30 rates-

https://lookaside.fbsbx.com/file/Modern%20Pathology.pdf?token=AWympGzXG_N5E1IzTelHLW5VpzJvZZgK_Sg1cyOAeGJVCvDziPjM1mrmpHjkpLXSFy7-z9Vtv_dN7G36Zp-QL_1pgPvgVofl2X_BOBrXmScBPcj0o_nsblt0slde-OBI9VyYT9zDTnGVnQrIFfAdYG1M