News ESAPS and EASAPS,Patient Safety,Breast,ESAPS Statements
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:
- Breast implant associated SCC is a very rare condition (
- SCC is not exclusively related to breast implants and has also been reported in patients in association with dental implants or pacemakers.
- 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
References
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