BISA Statement: Breast Implant Squamous Cell Carcinoma March 2023
On March 8, 2023, the FDA released a Safety Communication Update: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants. Squamous Cell Carcinoma is an emerging cancer that can be found in the scar tissue that forms around any type of breast implant, which means that this puts all individuals with breast implants at risk, even if it is rare. BISA, along with other advocate leaders, met with members of the FDA to discuss the update. Although patient advocates have known about BIA-SCC for several years, we hoped there would have been additional information shared about the update.
There is still a lack of data, information, reporting and guidance. Most patients with implants do not know about the risk of this potential cancer. Even patients that received implants recently may not have been warned because it has not been added to the informed consent checklist. Safety updates are slow to reach the public, if at all, including patients and doctors. There continue to be barriers to diagnosis, treatment and insurance coverage for these cancers and scar capsule removal and pathology guidance is needed. Unfortunately, much is still unknown about this emerging cancer.
The public might have been alerted earlier if the FDA enforced the original and agreed-upon requirement of the post-market studies. “Had the post-approval studies been continued and patients followed for symptoms, the public would have better data and information which was a missed opportunity that directly impacts patient safety today,” says Maria Gmitro, BISA’s President. The FDA is asking healthcare professionals and patients to file reports to FDA MedWatch.
What is known at this time?
As of March 8, 2023, 19 patients were reported in medical publications who developed squamous cell carcinoma (SCC) in the scar tissue surrounding their breast implants, which means this is 10 more than was originally reported by the FDA in September of 2022. It is unclear if these are duplicate reports or new reports. It was also reported that three patients have died. Although this is still considered rare, all patients that had breast implants placed for augmentation or from reconstruction after mastectomy regardless of type or the surface of the implant are now at risk.
It is important to note that 12 cases of lymphomas different from anaplastic large cell lymphoma (BIA-ALCL) that were caused by breast implants were reported last September by the FDA; however those numbers were not updated in the recent safety communication. Reported signs and symptoms included swelling, pain, lumps, or skin changes. In some cases, people were diagnosed after years of having breast implants. Risk factors for squamous cell carcinoma and the various lymphomas are currently unknown. The American Society of Plastic Surgeons (ASPS) has more information about BIA-SCC on their website.
There is a lack of data, information, guidance and reporting.
The most concerning issue is the lack of information about this emerging cancer and we fear this could potentially be a situation similar to BIA-ALCL. BIA-SCC has been found in all types of implants (saline, silicone, smooth and textured) and since breast implants have not been well tracked or studied, there is a significant lack of data. The FDA is struggling to obtain data since registries weren’t previously collecting data on any type of cancer except BIA-ALCL. Doctors reporting to those registries should also be reporting to the FDA as they can provide more data in an adverse event narrative than in a registry. Some registries are for plastic surgeons only and these cases are possibly being seen by other types of practitioners. PROFILE is currently only open to physicians practicing in the United States, with plans to accept international cases in the near future.
“The FDA did not implement the suggestions made by the advisory committee members at the 2019 hearing on safety of breast implants” says Consumer Rep Rachel Brummert. We believe that any and all types of practitioners can and should report directly to the FDA in order to expedite better understanding of the cases to the FDA and public. Madris Kinard, CEO of Device Events, former FDA public health analyst, and BISA Advisor says, “I would really like to start educating doctors about reporting directly to the FDA instead of to the manufacturer or to a registry.”
How is a patient considering or living with breast implants supposed to keep themselves safe?
If someone were considering breast implants today, the FDA informed consent checklist does not include the risk of BIA-SCC although the FDA has requested manufacturers add this information to the labeling documentation. We have proposed that the FDA make this amendment to the informed consent checklist. BISA is further concerned that when discussing the risk of BIA-SCC some doctors will minimize the aggressive and deadly nature of the disease or misrepresent the confidence behind risk estimates.
Safety updates are slow to reach the public, if at all.
After a patient receives breast implants, there is still no mechanism in place to warn patients when new safety issues arise, which BISA believes should be a requirement. Safety updates seem to be slow to reach the public and are primarily done through patient advocacy groups and the media. It is up to the patient to be aware of this emerging information. BISA would like to see the industries that are profiting from the sale of implants to step up and do more to help sponsor education efforts beyond plastic surgeons and expand to other medical specialties.
There are barriers to diagnosis and treatment.
Patients that have symptoms of BIA-SCC or any of the other implant-associated cancers are hampered in getting early diagnosis and treatment due to the lack of knowledge and awareness among radiologists and other healthcare providers on these diseases, their non-specific presentations, and how to diagnose or rule them out through testing. A further barrier to treatment and data is that many patients with implants obtained them for cosmetic reasons and such patients are facing insurance coverage denials as a result even in the face of an actual cancer diagnosis.
There is insurance denial for coverage of testing. “This denial can lead to metastasis and death in undiagnosed patients,” says Sarah Beckcom, BISA’s Vice President, who is personally still being monitored for being at risk for BIA-ALCL due to her explanted textured implants. It is important that all stakeholders work together to enforce current laws that, and enact new ones that, protect patients from being denied testing and treatment for cancer for unjust and illegal reasons.
Implant capsule removal and pathology guidance is needed.
BISA would like to see experts, and not just plastic surgeons, update their guidance to patients on the potential benefits of removing implant capsules and capsule testing given the new and emerging data on BIA-SCC. If there is any evidence suggesting that implant removal, capsulectomy, and/or capsule testing can reduce the risk of BIA-SCC development or progression, patients and doctors should consider it in decision making.
BISA would also like to see healthcare institutions and the College of American Pathologists update their policies regarding standardized pathologic processing of capsules in light of the emerging data on all implant-related cancers. These changes will help identify the true prevalence of these cancers and improve treatment and outcomes.
Current research related to cancer caused by breast implants is still ongoing.
During the 4th World Consensus Congress on BIA-ALCL and 8th International Breast Surgery Workshop in the fall of 2022, there was a session presented by Dr. Mark Clemens addressing BIA-SCC which begins at 6:09:44 of the recording. Jennifer Cook, BISA’s Director of BIA-ALCL Advocacy and also presenter at the conference said, “The presentation on BIA-SCC raised questions and highlighted insights into how these diseases are developing and what might be done to prevent them.” Jennifer Cook suffered from lymphoma caused by her breast implants (BIA-ALCL) and is the administrator of a support group for patients facing cancers caused by breast implants. We have added notes that Ms. Cook took from the session on BIA-SCC below.
Also, a new article “A Spectrum of Disease: Breast Implant-Associated Anaplastic Large Cell Lymphoma, Atypicals, and Other Implant Associations” by Megan E. Fracol MD, Megan M. Rodriguez BS, and Mark W. Clemens MD, MBA, was published in early 2023. This article addresses BIA-SCC as well as the latest information surrounding the other implant-related cancers.
Jennifer Cook’s personal notes from the BIA-SCC session:
The September 8, 2022 FDA safety communication brought attention to squamous cell carcinoma and other various lymphomas in the scar tissue (capsule) that forms around breast implants. The FDA describes these cases as “rare” and “emerging.”
BIA-SCC
Likely more aggressive than BIA ALCL
Epithelial-based
Emanates from the capsule
Pathology: sheets of squamous cells lining the capsule in nests and bundles
Exhibits highly invasive properties including spread to lymph nodes, local tissues and distant sites, muscle and bone.
These are real and arising from the capsule that is facing against the breast implant.
Can develop in other types of implants such as dental and orthopedic implants.
Marjolin Ulcer was discussed and the following comments were made about it:
Clinical precedence for BIA-SCC
Involves malignant degeneration arising within pre-existing cicatrix or scar
Presenting in an area of previously traumatized, chronically inflamed, or scarred skinPatients with chronic irritation and depressed immune systems may be more susceptible to a malignant transformation
Therapy generally involves wide local excision
MD Anderson has treated three BIA-SCC cases and they were approached with wide local excision.There are NCCN guidelines on SCC but they are NOT specific to BIA-SCC. We will have to make due with this until we can get more information on BIA-SCC patients.
BISA’s Final Thoughts
Patients are dying from a type of cancer that they wouldn’t have developed if they had not had breast implants placed. Not having proper data can lead one to believe that BIA-SCC is rare, however we can not be certain just how rare it is because it’s just beginning to emerge and has only more recently been recognized and identified collectively. There are too many vulnerabilities and unknowns associated with these devices and the public needs to be aware. “I encourage anyone who is considering breast implants, or with any surgical procedure, to do a self inventory and a risk versus benefit assessment, weighing the pros and cons when they are doing their research,” says Laura Willging, a Registered Nurse, Board Certified Patient Advocate and part of BISA’s board of directors.
This cancer risk is not just for the US, which means it is a global issue. The same breast implants are used all over the world and so far it has not been linked to any one specific type or manufacturer. “This cancer risk does not stop at any border and Health Canada has not released a statement or an updated safety communication to the public,” says Julie Elliott, BISA’s Canadian Representative.
Unfortunately, implant-related cancers, specifically BIA-SCC, are shining a spotlight on the devastating consequences of the FDA’s failure to require the completion of long-term post-approval studies and to mandate the implementation of systems designed to collect and disseminate critical safety information to patients. Despite these failures, research is happening and we hope experts will use that research to guide patients and doctors on what can be done in terms of prevention, symptom surveillance, symptom evaluation, and testing. BISA will continue to provide updates.
If you or if you know someone who has experienced these cancers, please reach out to BISA’s Director of BIA-ALCL Advocacy Jennifer Cook at jennifer.cook@bisanonprofit.org. Individuals may also join her BIA-ALCL & Other Cancers Support Group for more information.
For more information:
BIA-ALCL & Other Cancers Support Group
FDA: Things to Consider Before Getting Breast Implants
FDA: MedWatch Voluntary Reporting System
Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma (ALCL) etiology and Epidemiology (PROFILE)
National Breast Implant Registry (NBIR)
BISA Statement 2022: FDA Reports of New Cancers in Capsule Around Breast Implants
A Spectrum of Disease: Breast Implant-Associated Anaplastic Large Cell Lymphoma, Atypicals, and Other Implant Associations
ASPS Statement on Breast Implant Associated-Squamous Cell Carcinoma (BIA-SCC) from September 2022
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The Breast Implant Safety Alliance (BISA) is a patient-centered organization dedicated to improving breast implant safety—through direct collaboration with consumers, plastic surgeons, manufacturers, regulators, and advocates.
Contact: Maria Gmitro, President | 843.501.6873 | maria@bisanonprofit.org