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Copyright @ Pol J Cosmetol
 
ISSN 1731-0083
Sunday, 14.07.2024
PL EN
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Pol J Cosmetol 2020, 23(2): 108-111pladd to cart

Clinical trials of medical devices used in aesthetic medicine, on the example of breast implants


Fatima Dumicz

IQVIA RDS sp. z o.o.

Summary
The purpose of this article is to show the evidence that clinical trials concerning safety and health related outcomes after breast augmentation are indeed conducted. Followed by an indication of an early subject satisfaction data. The systematic review includes "adjunct studies" (1992-2006) and 10 years results from the clinical trials started in 1999 with follow-up period initiated by Mentor and Allergan manufacturers. Allergan recruited 715 patients and Mentor 1008. In both studies, the most frequent adverse events were mainly local complications, not systematic ones. Allergan´s and Mentor´s silicone-filled breast implants were approved by the U.S. Food and Drug Administration in 2006. Data from the studies can help surgeons and patients in decision-making regarding the surgery. Clinical studies in aesthetic medicine are ongoing.

Key words: aesthetic medicine, breast implants, silicon, Allergan, Mentor, BIA-ALCL