EASAPS/ESAPS Statement on reports of SCC associated with breast implants (BIA-SCC)

EASAPS/ESAPS Statement on reports of SCC associated with breast implants (BIA-SCC)

By : Nora Nugent Date : Mar 27,2023

EASAPS/ESAPS Statement on reports of SCC associated with breast implants (BIA-SCC)

Dear Members,

On 8th September of 2022, the U.S. Food and Drug Administration (FDA) posted a Safety Communication on their website (https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda), informing the public about reports of cancers, including breast implant associated squamous cell carcinoma (BIA-SCC) and various lymphomas (besides BIA-ALCL) in the capsule surrounding breast implants.

BIA-SCC has been reported as occurring in the capsule around both textured and smooth surfaces as well as in the capsule around both silicone and saline filled breast implants. Case reports, although very rare, have been published for several decades. So far, 26 cases have been reported worldwide. Based upon the literature, there appears to be a bias towards breast implants in situ for many years (15-42). Patients with breast implants have reported delayed swelling of the breast (late seroma), pain, redness and hardness (capsular contracture) of the breast.


ESAPS/EASAPS opinion based on current knowledge:

  1. Breast implant associated SCC is a very rare condition (
  2. SCC is not exclusively related to breast implants and has also been reported in patients in association with dental implants or pacemakers.
  3. Thus far, there is no science based rationale for advising explanting unaffected breast implants based upon these new reported case reports of breast implant associated squamous cell carcinomas.


ESAPS/EASAPS recommendations to members and society partners:

The Scientific committee and Board of ESAPS / EASAPS will continuously follow international publications and reports on the subject and investigate the incidence of breast implant related SCC in European countries.

1.       BIA-SCC and various lymphomas should be added to the information section on BIA-ALCL in the informed consent discussion with patients considering breast augmentation or attending for secondary breast implant assessment or surgery. It should be stressed that with current data, this appears to be a very rare complication.

2.      Awareness for physicians and patients is of paramount importance. Any abnormality and deviation from the normal course after breast augmentation with a breast implant should be evaluated by a board-certified plastic surgeon.

3.      In the event of a confirmed case of BIA-SCC, it should be reported to both your national society as well as the ESAPS/EASAPS (birgit.stark@ki.se - president of ESAPS/EASAPS and cmagliocca@tiscali.it - representative for national societies) in order to get further epidemiological insight and to strengthen surveillance regarding this topic. If your country has a breast implant registry or regulatory body notification system for medical device issues, the case should be entered into this as well.


October 13th, 2022


Birgit Stark                                   Mario Mendanha

President ESAPS/EASAP                 Chair of the Scientific Committee

On behalf of the BOARD                 On behalf of the Scientific Committee



Buchanan PJ, Chopra VK, Walker KL, Rudolph R, Greco RJ. Primary Squamous Cell Carcinoma Arising From a Breast Implant Capsule: A Case Report and Review of the Literature. Aesthet Surg J. 2018 Jun 13;38(7). doi: 10.1093/asj/sjy092. PMID: 29659713.

Cordeiro PG, Ghione P, Ni A, et al. Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants. J Plast Reconstr Aesthet Surg. 2020;73:841–846.

Goldberg MT, Llaneras J, Willson TD, Boyd JB, Venegas RJ, Dauphine C, Kalantari BN. Squamous Cell Carcinoma Arising in Breast Implant Capsules. Ann Plast Surg. 2021 Mar 1;86(3):268-272. doi: 10.1097/SAP.0000000000002524. PMID: 32804719.

Olsen DL, Keeney GL, Chen B, Visscher DW, Carter JM. Breast implant capsule-associated squamous cell carcinoma: a report of 2 cases. Hum Pathol. 2017 Sep;67:94-100. doi: 10.1016/j.humpath.2017.07.011. Epub 2017 Jul 22. PMID: 28739500.

Kitchen SB, Paletta CE, Shehadi SI, Bauer WC. Epithelialization of the lining of a breast implant capsule. Possible origins of squamous cell carcinoma associated with a breast implant capsule. Cancer. 1994 Mar 1;73(5):1449-52. doi: 10.1002/1097-0142(19940301)73:53.0.co;2-j. PMID: 8111712.

Liu Z, Liu, C, Chengglong, Z, Yu, Q, Zhang G, Wang X, Yu Z. Breast prosthetic implant-associated Squamous Cell Carcinoma: A case report and Literature Review. Research Square. 2021 Jan. doi.org/10.21203/rs.3.rs-141167/v1

Paletta C, Paletta FX Jr, Paletta FX Sr. Squamous cell carcinoma following breast augmentation. Ann Plast Surg. 1992 Nov;29(5):425-9; discussion 429-32. doi: 10.1097/00000637-199211000-00009. PMID: 1444131.

Satgunaseelan L, Cheung D, Reddy, J. Breast Implant-Associated Squamous Cell Carcinoma – A Rare Long Term Complication. Pathology. Volume 47, Supplement 1, S72-S73, JANUARY 01, 2015.

Alikhan MB, Nassar A, Mansoor I. Squamous metaplasia on the breast implant capsule. Int J Surg Pathol. 2010 Dec;18(6):570-4. doi: 10.1177/1066896908329587. Epub 2009 Jan 14. PMID: 19147510.

Soni SE, Laun JC, Beard AS, Kuykendall LV. "Breast Implant Capsule-Associated Squamous Cell Carcinoma During Pregnancy: A Mimicker of Breast Implant-Associated Anaplastic Large Cell Lymphoma". Plast Reconstr Surg. 2022 Aug 12. doi: 10.1097/PRS.0000000000009506. Epub ahead of print. PMID: 35960919.

Whaley RD, Aldrees R, Dougherty RE, Prieto Granada C, Badve SS, Al Diffalha S. Breast Implant Capsule-Associated Squamous Cell Carcinoma: Report of 2 Patients. Int J Surg Pathol. 2022 Mar 18:10668969221086940. doi: 10.1177/10668969221086940. Epub ahead of print. PMID: 35300538.

Zhou YM, Chaudhry HE, Shah A, Andrews J. Breast Squamous Cell Carcinoma Following Breast Augmentation. Cureus. 2018 Oct 3;10(10):e3405. doi: 10.7759/cureus.3405. PMID: 30533339; PMCID: PMC6278994.

Zomerlei TA, Samarghandi A, Terando AM. Primary Squamous Cell Carcinoma Arising from a Breast Implant Capsule. Plast Reconstr Surg Glob Open. 2016 Jan 7;3(12):e586. doi: 10.1097/GOX.0000000000000567. PMID: 26894011; PMCID: PMC4727695.

Bodagh N, Pappa E, Farooqi F., Multidisciplinary surgical team approach for excision of squamous cell carcinoma overlying pacemaker site. BMJ Case Rep. 2018 Feb 6; 2018:bcr2017221660. Doi: 10.1136/bcr-2017-221660. PMID: 29437678