What were the most frequent complications seen in the Core Studies for the Allergan and Mentor silicone gel-filled breast implants?
In the Mentor and Allergan (formerly Inamed) Core Studies, the most frequent complication was reoperation (additional surgery). Capsular contracture was another frequent complication. Other frequent complications included implant removal, breast pain, nipple sensation changes, and asymmetry. For both Core Studies, some women experienced more than one complication. In addition, the complication rates were typically higher for revision (reoperation) implants than for primary (first time) implants.
In the Mentor and Allergan (formerly Inamed) Core Studies, the most frequent complication was reoperation (additional surgery). Capsular contracture was another frequent complication. Other frequent complications included implant removal, breast pain, nipple sensation changes, and asymmetry. For both Core Studies, some women experienced more than one complication. In addition, the complication rates were typically higher for revision (reoperation) implants than for primary (first time) implants. For a summary of the Core Study data for each company, see the Labeling for Approved Breast Implants.
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