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The Breast Implant Removal System is a single-patient, single use suction device used to assist in the removal of one intracapsular ruptured silicone breast implant. Not intended for en bloc removal. Not intended to remove residual silicone or be applied directly to tissue.

The breast implant removal system is a two-piece bottle with a concave shaped nozzle on one end and a tapered fitting port on the opposite end that allows attachment to a vacuum source. The nozzle is placed against the shell of a ruptured implant, and once vacuum suction pressure is applied, the implant and silicone contents are drawn into the bottle. The tank has a tapered port for connection to vacuum tubing that interfaces with a vacuum source. The bottle is intended to be used with a standard OR wall vacuum or a portable surgical aspirator pump. The nozzle has a "fish-mouth" concave shaped opening to facilitate engagement between the nozzle and the implant, as well as lubricious hydrophilic coating to reduce friction in delivering the implant into the specimen bottle. External contoured features on the bottle aid in the user grip and manipulation of the container. The bottle has vent holes which must be covered to apply suction. After removing the bulk of the implant, any residual leaked silicone material is removed by conventional techniques such as manual removal/extraction. The tank can be opened for the purpose of implant examination or implant manufacturer return.