5th World Consensus Conference on BIA-ALCL: Recap and Major Takeaways
BISA virtually attended the 5th World Consensus Conference on BIA-ALCL, which took place in Rome, Italy, on April 20.
At the annual conference, global experts and regulatory authorities presented and discussed the latest information and developments regarding BIA ALCL and other breast implant-associated cancers.
The conference is now available to stream on YouTube. Here’s what you need to know.
What is BIA-ALCL?
Breast Implant-Associated Lymphoma (BIA-ALCL) is a type of non-Hodgkin's lymphoma, a cancer of the immune system, caused by exposure to textured breast implants and textured expanders.
BISA Contributions and Patient Advocate Involvement
Not only did BISA stream this year’s conference live, but BISA members Jennifer Cook and Terri McGregor also shaped the content of the conference by submitting topics of particular importance to patients and patient advocates. In response to our requests, conference organizers Dr. Fabio Santanelli di Pompeo and Dr. Mark Clemens created a separate virtual session focused on patient education at the end of the conference.
The virtual session also included a presentation by BIA-ALCL survivor and patient advocate Krisztina Sajósi from Hungary.
Krisztina Sajosi’s presentation, titled Shaping Tomorrow: Perspectives on the Future of BIA-ALCL, is extremely powerful and a must-watch!
Watch on YouTube: Replay the World Consensus Conference on BIA-ALCL
There are two YouTube links for the 5th World Consensus Conference on BIA-ALCL. One is for the in-person portion of the conference. The other is for the virtual patient education portion. There is a time-stamped list of the presentations in the description box of each video.
BIA-ALCL Conference Highlights
After attending online, BISA analyzed all five sections of the conference. Here’s a brief summary of some of what we found to be new or particularly noteworthy, organized by topic.
Timestamps are provided to help you locate the approximate location of the information highlighted. As stated above, there are two YouTube video links for the BIA ALCL-focused portion of the conference, so if you don’t find the relevant information using the provided time stamp in one video, try the other one.
Case Numbers and Risk Estimates
BIA ALCL Pathogenesis and Epidemiology
Registry Data and Microtextured Implants
Breast Implants Associated Cancers are Associated with All Breast Implant Types
Data Gaps
BIA ALCL Risk Factors
Symptoms of BIA ALCL and Other Breast Implant-Associated Cancers
Diagnostic Imaging and BIA ALCL
Diagnosis and Treatment of BIA ALCL and Other Breast Implant-Associated Cancers
The Role of Radiation in the Treatment of BIA ALCL
Missteps
Reconstruction Options after Diagnosis of a Breast Implant-Associated Cancer
Insurance Denials
Types of Capsulectomy
Prophylactic Removal of Textured Breast Implants in Asymptomatic Patients
Conflicts of Interest in Plastic Surgery
Centers of Excellence for BIA ALCL
Psychological Implications of BIA ALCL
Case Numbers and Risk Estimates
Global tracking has identified at least 1618 cases of BIA ALCL with 49 deaths, although many countries are still not providing updated numbers. (Clemens, 07:18:55)
The prevalence of BIA ALCL in patients exposed to a macrotextured implant may be as high as 1 in 115. (Kolasiński, 06:39:03)
The prevalence of BIA ALCL in Dr. Cordeiro’s cohort of patients implanted with primarily Biocell implants is now 1 in 300. (Cordeiro, 06:18:30) This is an increase from the risk of 1 in 354 reported in his frequently cited article for the same cohort. Statistical analysis shows that the cumulative risk for his patients 15 to 20 years post implantation is about 1 in 100. (Cordeiro, 06:19:04)
There are reasons why reported risk estimates for BIA ALCL vary and why some are probably inaccurate. (Cordeiro, 06:13:49)
The disconnect between the number of reported cases and the number of actual cases may be because some patients with fluid-only disease were completely treated by implant exchange without ever knowing they had the disease. Treatment of BIA ALCL by removing the implant alone is NOT advocated for because two-thirds of patients will have capsule involvement. (Clemens, 02:44:46)
Some cases of BIA ALCL may be undiagnosed because they don’t present with the typical very large effusion. Sometimes, effusions in BIA ALCL patients are quite small, but in some cases, sending that small amount of fluid will result in a diagnosis of BIA ALCL. (Hunt, 06:49:31)
The peak number of cases of BIA ALCL in the U.S. is anticipated to be in 2026 or thereafter. (McCarthy, 01:24:43)
There are 42 reported worldwide cases of BIA-BCL, and 31 reported worldwide cases of BIA-SCC. (Fracol, 01:05:52)
MD Anderson has treated a significant number of BIA ALCL cases as well as cases of other breast implant-associated cancers. (Fracol, 01:05:52)
BIA ALCL Pathogenesis and Epidemiology
BIA ALCL begins on the surface of a textured implant and in the fluid that is between the implant and the scar capsule. It frequently progresses into the implant capsule but does not arise from the capsule itself. (Clemens, 02:44:11)
Registry Data and Microtextured Implants
Registry data from Denmark reaffirms a link between BIA ALCL and microtextured implants. Five BIA ALCL patients from Denmark had exclusive exposure to a microtextured implant. (Rosenkrantz Hølmich, 05:52:31)
Breast Implant Associated Cancers are Associated with All Breast Implant Types
Breast implant-associated cancers are associated with all types of breast implants, including smooth, textured, silicone, and saline. There are cases of BIA BCLs and BIA SCC found in patients with a history of smooth-only implants. (Clemens, 07:26:40; 07:28:01) (Fracol, 01:07:50)
There is one case of BIA ALCL in the PROFILE database in which documentation would suggest that the patient had a smooth history only, but at this time, the documentation cannot be verified. (McCarthy, 01:24:48)
Data Gaps
Dr. Clemens made a direct plea to the manufacturers attending the conference to release critical undisclosed information relevant to understanding the risk of breast implant-associated cancers. (Clemens, 07:29:55)
Brazil is the biggest textured implant market in the world, but it does not have a breast implant registry. There are concerns about BIA ALCL reporting and the following of proper BIA ALCL diagnostic and treatment protocols in Brazil. (Groth, 05:56:48)
PROFILE is now collecting data on BIA-SCC and other breast implant-associated lymphomas in addition to BIA ALCL. (McCarthy, 01:18:51)
The concepts of registering a breast implant versus a breast implant registry are frequently confused. (Clemens, 02:58:30)
BIA ALCL Risk Factors
Soon-to-be-published evidence will identify potential factors that may increase and/or decrease a patient’s risk for developing BIA ALCL. (Santanelli di Pompeo, 01:54:00)
Data suggests that patients with BRCA and TP53 germline mutations may develop BIA ALCL more quickly after exposure to a textured implant than patients without such mutations. (Santanelli di Pompeo, 01:46:07)
Symptoms of BIA ALCL and Other Breast Implant-Associated Cancers
The symptoms of the different breast implant-associated cancers were compared. (Fracol, 01:08:42)
Less common and subtle presentations of BIA ALCL were discussed. (Clemens, 02:36:57)
Patients should stay informed about the full spectrum of BIA ALCL symptoms, including uncommon presentations involving night sweats and skin rashes, and seek expert second opinions if they don’t get answers. (Clemens, 03:02:24)
The symptoms of BIA ALCL patients in the PROFILE database were outlined. (McCarthy, 01:25:34)
There is one case of BIA ALCL in the PROFILE database where the only reported symptom was non-breast skin lesions. (McCarthy, 01:25:35)
Having bilateral symptoms does not rule out BIA ALCL since BIA ALCL can be bilateral and present with bilateral symptoms. BIA ALCL can also be bilateral without bilateral symptoms. (McCarthy, 01:26:02) (Sorotos, 00:58:17)
A significant percentage of BIA-BCL and BIA-ALCL cases have been diagnosed incidentally and/or in asymptomatic patients. (Fracol, 01:02:39; 01:08:42; 01:10:57) (McCarthy, 01:27:08)
CC is a presenting symptom of BIA ALCL. (McCarthy, 01:25:56; 01:27:08)
The benign and malignant causes of breast swelling and/or fluid around a breast implant were discussed. (Myckatyn, 00:46:37)
Diagnostic Imaging and BIA ALCL
Dr. Clemens discussed the importance of a thorough imaging evaluation BEFORE surgery. (Clemens, 02:40:58)
The role of the different imaging modalities in detecting BIA ALCL was discussed. (Santanelli di Pompeo, 01:33:50) (Clemens, 02:31:02)
A palpable mass coupled with skin redness was falsely negative on MRI and ultrasound, resulting in a delayed diagnosis. (Martelli, 07:08:12)
Diagnosis and Treatment of BIA ALCL and Other Breast Implant-Associated Cancers
A manuscript outlining the diagnostic and treatment algorithms for BIA ALCL, BIA BCL, and BIA SCC is pending publication. (Clemens, 07:29:00)
A plastic surgeon addressed the treatment of BIA ALCL and other breast implant-associated cancers. (Fracol, 01:14:02)
The NCCN guidelines on BIA ALCL have been updated as of April 2024. The NCCN guidelines now include an additional 8-page section discussing the relevant medical literature. (Clemens, 07:20:42)
The importance of testing late-onset fluid collections around breast implants for the full spectrum of implant-associated cancers was highlighted. Specific attention was drawn to the need to note the presence of any squamous cells in the fluid, as that finding should trigger further testing of any mass and/or the capsule to further rule out the presence of BIA SCC. (Clemens, 07:29:05) (Fracol, 01:12:38)
Specific attention was also drawn to the fact that, although CD 30 testing is critical for identifying BIA ALCL, the absence of CD30-positive cells does not rule out other implant-associated lymphomas that are not CD30 positive, and it does not rule out BIA SCC. Therefore, once BIA ALCL is ruled out, pathologists should take steps to rule out other implant-associated cancers with the tests relevant to those diseases, especially if atypical and/or squamous cells are seen. (Clemens, 07:30:50) (Myckatyn, 00:46:49)
Early detection and complete removal of the breast implant, capsule, and associated masses when possible are important for prognosis in patients with all implant-associated cancers. (Fracol, 01:04:10; 01:09:28)
Multiple doctors discussed BIA ALCL treatment approaches and outcomes with a focus on advanced and recurrent disease. (Iyer, 02:13:53) (Martelli, 07:05:15) (Hunt, 06:47:03) (Clemens, 02:40:58)
The case is made for removing the implant and capsule on both sides even if the diagnosis of BIA ALCL appears initially to only involve one breast. (Myckatyn, 00:45:40)
The challenge of indeterminate and/or atypical findings where the correct diagnosis is unclear or uncertain was addressed. These cases should probably be referred to tertiary centers and/or expert hematopathologists so additional tests can be performed to identify what is happening. (Clemens, 07:29:05) (Clemens, 02:39:12)
The Role of Radiation in the Treatment of BIA ALCL
The role of radiation in the treatment of BIA ALCL was discussed, including the situations where radiation can be considered, the techniques used to keep radiation off critical structures, and the risks of radiation. (Gunther, 01:57:02)
Radiation has played an important role in the treatment of some advanced BIA ALCL cases at MD Anderson. (Hunt, 06:57:17)
Missteps
Some plastic surgeons do not follow best practices. Dr. Myckatyn discussed the reasons for it, its consequences, and how to address it. (Myckatyn, 00:36:07)
If BIA ALCL is suspected, as much testing as possible should be done. (Miranda, 00:09:48)
An effusion of 10 mls is adequate for cytopathology. (Miranda, 00:08:00).
More extensive testing can be done if 50 mls are aspirated. (Miranda, 00:08:30).
The diagnosis of BIA ALCL is not always straightforward and can be missed. (Miranda, 00:16:48)
It can be missed on cytology (Miranda, 00:07:14).
It can also be missed sometimes in a capsule if CD30 testing is not done. (Miranda, 00:10:27; 00:11:01).
Two patients have died from progressive disease because the disease was not diagnosed in a prior specimen. (Miranda, 00:12:45)
If few or no inflammatory cells are seen when testing a capsule, then CD30 testing is not necessary. (Miranda, 00:14:30)
Reconstruction Options after Diagnosis of a Breast Implant-Associated Cancer
Immediate reconstruction with a breast implant is not recommended in patients diagnosed with BIA BCLs or BIA SCC. (Fracol, 01:14:26)
Several plastic surgeons discussed reconstruction after a diagnosis of BIA ALCL. (Clemens, 02:50:22) (Myckatyn, 00:39:26) (Fracol, 01:13:08)
Insurance Denials
Cosmetic augmentation patients can face insurance denials for BIA ALCL treatment. In fact, some insurance policies expressly exclude coverage for BIA ALCL treatment in cosmetic augmentation patients. Patients should check whether their current insurance policy excludes coverage for BIA ALCL treatment and consider changing their policy if it does. Guidance for appealing insurance denials was also provided. (Clemens, 02:55:57)
Types of Capsulectomy
The different types of capsulectomy and the different reasons for performing them were discussed. (Clemens, 02:48:18) (Myckatyn, 00:37:44)
Prophylactic Removal of Textured Breast Implants in Asymptomatic Patients
Prophylactic removal of textured breast implants in asymptomatic patients was discussed. (Santanelli di Pompeo, 01:44:05; 01:55:33)
The NCCN guidelines now address the prophylactic explantation of textured implants. (Clemens, 07:20:42)
Conflicts of Interest in Plastic Surgery
Dr. Swanson discussed the problem of conflict of interest in plastic surgery. (Swanson, 04:24:58)
Centers of Excellence for BIA ALCL
Dr. Sorotos discussed BIA ALCL centers of excellence, including their characteristics and how to identify them. He also discussed specific cases where missteps occurred, highlighting the importance of choosing a BIA ALCL center of excellence when you are at risk for the disease. (Sorotos, 00:49:13)
Psychological Implications of BIA ALCL
A clinical psychologist presented on the psychological impact of BIA ALCL. (Lai, 00:17:14)
Breast Implant Safety Alliance (BISA) is a 501(c)3 women-owned nonprofit, patient-centered organization dedicated to improving breast implant safety and awareness—through direct collaboration with consumers, medical professionals, manufacturers, regulators, and advocates. BISA is a 100% volunteer organization not funded by implant manufacturers.
For questions, please contact Jennifer Cook, Director of BIA-ALCL Advocacy. Email her directly at jennifer.cook@bisanonprofit.org.
