The device connects to standard operating room suction and is designed to support faster, more controlled explantation without requiring additional capital equipment or specialized training.
Applied Medical Technology Inc has been granted US Food and Drug Administration (FDA) 510(k) clearance for Explant Express, a breast implant removal device designed to support efficient, controlled explantation of ruptured silicone breast implants.
Explant Express is designed to enable rapid removal of ruptured implants, keeping silicone gel away from gloves, instruments, and the surgical field.
The device’s separable halves allow for post-procedural inspection of extracted material.
Explant Express is a breast implant suction retrieval device engineered to help plastic and reconstructive surgeons remove ruptured implants while minimizing contact between silicone gel and the surgical field. By connecting to standard operating room suction, the device aims to simplify ruptured breast implant explantation without adding capital equipment or requiring advanced training.
“FDA clearance of Explant Express represents an important milestone in advancing tools that support efficiency, cleanliness, and control during ruptured breast implant removal procedures,” says Joseph Harr, surgical sales manager at Applied Medical Technology, in a release. “Traditional explantation techniques can be time-consuming and messy. Explant Express was designed to reduce operating time and help maintain a clean surgical field – without disrupting existing workflows.”
Explant Express is intended for use during ruptured breast implant explantation procedures and features an ergonomic design suitable for a range of implant sizes.
Manufactured in the United States, Explant Express expands Applied Medical Technology’s portfolio of FDA-cleared surgical solutions. Commercial availability of Explant Express will be announced in the coming weeks.
