Awareness is increasing, many thanks to Lucas Boer, Inca Slaats and Peter Bult.
Conclusions
In this case series, we found that noncohesive as well as cohesive gel SBIs bleed silicones, resulting in migration of silicones beyond the capsule, which occurred in 86.6% of women investigated. As SBIs are associated with complications and even cancer, women should be well informed about the potential harms before these implants are placed into the body.
As the safety of SBIs is questioned more and more, we propose some recommendations. First, future studies should focus more on a potential causative relationship between silicones and complications and malignant neoplasms (BIA-ALCL), including samples from healthy women without SBIs and women with implants with and without signs of toxic effects. Such analyses might include blood analysis with ciRNaseq technology for early stage detection of silicone toxic effects, other blood analyses (eg, antibodies against silicones, cytokine levels, number of different types of inflammatory cells), analyses of hairs of the crown to detect systemic spread of silicones (eg, platinum levels), tissue analyses (eg, amount of silicones, type and amount of inflammatory cells, cytokine levels), and analysis of potential (eg, genetic) predisposition of women for developing silicone-related complications.
Second, the use of silicone gel–filled implants should be stopped until their safety has been proven. For breast reconstruction, autologous reconstruction should be used as often as possible. If silicone shell breast implants are used (when other options are not possible), they should be filled with saline or other known nontoxic fluids. If patients experience complications from their SBIs, explantation (with complete excision of the capsule) should be offered. The costs of this procedure should be reimbursed by the health insurance companies.
Published in JAMA Network Open
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