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2011 the United States Food and Drug Administration (FDA) confirmed on its website that breast implants can cause the rare tumor entity known as anaplastic large-cell lymphoma (ALCL) (1). This sparked growing interest both in professional journals and in the daily press. The first case of ALCL in a woman with breast implants was published in 1997 (2). The most recent publication from the FDA lists 414 implant-associated events (medical device reports, MDR) relating to breast implants, and the PROFILE database of the Plastic Surgery Foundation contains 516 cases (3,4).Owing to the low prevalence and as yet unknown incidence of breast implant-associated (BIA) ALCL, the existing treatment evaluation data come from case reports.The published guidelines are on the level of expert consensus, therefore treatment recommen- SummaryBackground: There has been increasing evidence in recent years that breast implants can, in rare cases, be associated with the development of an anaplastic large-cell lymphoma (ALCL).Methods: This review is based on relevant publications retrieved by a selective search in PubMed for articles that appeared from the time of the initial description of breast-implant-associated ALCL onward (1997 to January 2018), and by a further search in German nationwide databases.Results: 516 pathologically confirmed cases of breast-implant-associated (BIA) ALCL were documented around the world until February 2018; seven of these arose in Germany and were reported to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). In approximately 80% of the affected women, the BIA-ALCL manifested itself as a late-developing seroma at the implant site; in the rest, as a solid tumor with or without an accompanying seroma. The mean implant exposure time ranged from 7 to 13 years on average. 16 fatalities have been reported worldwide. Among the 7 cases reported in Germany, four women had undergone breast reconstruction with implants after breast cancer surgery, and two had undergone breast augmentation surgery. In all patients, the entire capsule-and-implant unit was resected. One patient underwent chemotherapy and one further patient underwent chemotherapy and adjuvant radiotherapy. Conclusion:The risk that a woman with breast implants will develop a primary anaplastic large-cell lymphoma is estimated at 0.35 to 1 case per million persons per year. The incidence of implant-associated ALCL is thus very low, yet nevertheless markedly higher than that of other primary lymphomas of the breast. Because of the low case numbers, recommendations for the diagnostic evaluation and treatment of this entity have not been adequately evaluated. Treatment with primary curative intent for BIA-ALCL confers a much better prognosis than when performed for a systemic ALCL. Whenever a patient with a breast implant presents with a late-developing seroma, BIA-ALCL should be included in the differential diagnosis. This diagnosis is reportable.

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Introduction: Implant-based or expander-supported breast reconstruction is an established surgical method after mastectomies due to cancer or to prophylactic reasons. Patient reported outcome (PRO) and cosmetic outcome after breast reconstruction with a synthetic surgical mesh was investigated in a prospective, single-arm, multi-center study. Material and methods: Primary or secondary implant-based breast reconstruction with support of TiLOOP® Bra was performed in 269 patients during the PRO-BRA study. PRO 12 months after breast reconstruction was evaluated using Breast-Q questionnaire. Cosmetic outcome was evaluated by two independent experts by means of pictures taken preoperatively and at the follow-up visits. Results: Breast-Q and 12 months FU were completed by 210 women. Patients without adverse event had a significantly higher Breast-Q score for "sexual well-being" (p ¼ 0.001); "psychosocial well-being" was negatively influenced by prior therapies (p < 0.01), and older patients had significantly lower scores at 12 months FU compared to pre-OP for "satisfaction with breasts" (p < 0.01) while the opposite was true for younger patients. Unilateral surgery resulted in reduced "satisfaction with breast" at 12 months FU (p < 0.01). Radiotherapy negatively influenced "satisfaction with breast", "sexual well-being" and "physical well-being chest". The cosmetic evaluation showed a significant difference (p < 0.001) in the evaluation by the patients and experts with the patients' assessment being worse compared to experts' assessment. Conclusion:Our study showed that two years after implant-based breast reconstruction with support of TiLOOP® Bra PRO is influenced by different factors. This information can be used to improve the decision-making process for women who chose implant-based breast reconstruction.