BIA-ALCL Implant related lymphoma

JameeCook

BIA-ALCL Trifold Brochure from the ASPS and the PSF

https://drive.google.com/file/d/1UzrZwmSeSPKZPIFIlAfy8bvn_21iL2T9/view?fbclid=IwAR2DYZs33lGzWA-WkmsdCPX0j8vspDOxQdZr-X5O_-9SSAqnrW8Mb2my0iw

JameeCook

How to Diagnose and Treat Breast Implant Associated Anaplastic Large Cell Lymphoma BIA-ALCL

https://drive.google.com/file/d/1BP2FiMfF-BPKq_Dxn0OPY0d03o51hdMI/view?fbclid=IwAR3NcnLhMJoCOLcqtbPEbjtvZ_JVMYNt8ofTs5u7QNditdd_sY9imKwOOFM

JameeCook

Important WebEx from ICOPLAST (very informative)

https://www.youtube.com/watch?v=d_3-vW5hSvE&feature=youtu.be&fbclid=IwAR1wQWJDRqSH__0UPm7ISRsTCaZU7JLZD-WMQag2qQzRzLCR-Dz4SgpUcv4

JameeCook

How I Treat Breast Implant Associated Anaplastic Large Cell Lymphoma BIA-ALCL

http://www.bloodjournal.org/content/bloodjournal/132/18/1889.full.pdf?fbclid=IwAR0p97IdCNTKC1yfjmzw8ncC5ohlwGHDUW48K6Wys4BZvXFcxvvA21sPDbo&sso-checked=true

rmgrmg

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.

rmgrmg

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.

rmgrmg

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.

rmgrmg

Okay, JameeCook I have read all of your posts about BIA ALCL and am VERY impressed with your knowledge concerning the lastest on ALCL. I have textured biocell implant Inamed brand, which was taken over by Allergan. I currently have had the implants for over 15+ years without symptoms, but I am getting these out. I called a large US cancer center where I got these implants about a year ago concerning ACLC and they said not to worry and keep my implants. Since then I just got a letter from them, stating my Dr. could remove the implants if I wished or switch them out, though the FDA did not recommend removal for assymptomatic textured at this point. Oh boy, this got me mentally disturbed. I will have a consult appointment to get fully capsulectomy and implant removal and wished I had these had been out yesterday! Since you are well abreast, no pun intended, on this topic would you mind telling me if you think our explant docs should be on the online list of commonly used capsulectomy doctors-https://www.breastimplantillness.com/explant-surgeons/ ? Don't know if my breast PS doc is on this list, but he has 15 years experience at mainly breast plastic surgery, did fanstastic surgery on my friend's reconstruction, autologous DIEP. and has excellent online reviews doing reconstruction following breast cancer, along with teaching breast surgery at Medical School and now clinically teaches breast surgery. Yes, he has a nice long positive record and his office says of course he is experienced in capsulectomy w/implant removal. Anyway, Jamee since I highly respect your posts and medical insights, please give me your opinion if this doc I found should be on the so called list of En Bloc Capsulectomy doctors that some mention here. Thanks a million, Rmg

rmgrmg

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

Irony

JameeCook, thank you so much for all of the information. I saw my plastic surgeon today. He believes my risk is closer to the 1:3000 because I have Allergan 410s. Not only is my right implant slipping lower, but I also have synmastia and possibly a pec tear. I'm going to start OT for the pec pain. I will have the implants replaced with smooth implants. I'm still reeling from my open heart surgery, so I'm thinking of giving myself some time and doing the exchange in Sept. Thanks to you, I asked about a capsulectomy. He said they try to remove all of the capsule, sometimes it isnt possible to get it all due to adhesions, but he would do his best. Again, thanks for the info. I went in knowing what to ask.

rozem

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 

rmgrmg

There is another topic on BIA ALCL on this forum called "Health concerns of Allergan Textured implantson" about explantation of textured implants-

https://community.breastcancer.org/forum/44/topics..

and there is a New website for explantation due to BIA ALCL--

https://www.facebook.com/groups/ALCLinwomenwithbre...

Sharon2010

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.

OneFoot

Thank you @JameeCook. My team is including possible BIA-ALCL as we move forward and it’s is included in my current plan. At this point in time they are only excising the lump and tissue margin, not touching the implant or capsule. Fluid was noted in the capsule on Ultrasound. I may flick an email to Anand just to be on the safe side.

Sharon2010

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

VegGal

The report looks good. Calcifications are not unusual in the capsule and they didn't see anything weird. 

rmgrmg

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