Patient is a healthy (b)(6) year-old woman with no prior medical history who desired bilateral subgranular breast augmentation using smooth round silicone gel implants.She underwent surgery on (b)(6) 2020 without intraoperative problems during which the inplant funnel device ((b)(6)) was used to deliver bilateral smooth round mentor silicone gel implants.On (b)(6) 2020, she reported a fever and began broad-spectrum antibiotics on (b)(6) 2021.On (b)(6) 2021, she experienced drainage of brown murky fluid from the right breast incision.She was returned to the operating room on (b)(6) 2021, where she was found to have brown murky fluid around the left breast implant as well.Both implants were removed, and pockets were irrigated and closed.Culture results have not grown any bacteria.Fda safety report id # (b)(4).
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