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Patients with either saline- or silicone gel–filled breast implants may have a very small but significant risk for a rare cancer called anaplastic large-cell lymphoma (ALCL), a cancer of the immune system, adjacent to the implant. This is currently under investigation and its existence should be considered if there is a build up or collection around the implant (seroma) years after the original surgery. Because the risk is very small the current policy is one of data collection only and no changes have been recommended for the use of breast implants or the frequency of follow up after breast implant surgery. The FDA continues to state that breast implants are "safe and effective when used as labeled."
