New Surgical Tool Aims to Transform Ruptured Breast Implant Removal

BRECKSVILLE, Ohio – February 25, 2026 – Applied Medical Technology, Inc. (AMT) today announced the nationwide U.S. launch of the Explant Express®, a novel surgical device designed to fundamentally change how surgeons manage a common and challenging complication of breast augmentation: implant rupture. The single-use, suction-assisted tool aims to provide a cleaner, faster, and more controlled removal of ruptured silicone breast implants, a procedure that has long been a source of difficulty for surgeons and anxiety for patients.

This launch comes at a time of heightened awareness around breast implant safety and a growing number of patients seeking explantation. By targeting a specific procedural pain point, AMT is introducing a technology that could set a new standard for care in breast revision and explant surgery.

The Clinical Challenge of Implant Ruptures

Breast implant rupture is a well-documented risk, and its management presents significant clinical challenges. According to FDA data, the risk of silicone gel implant rupture can be as high as 24% over a 10-year period. Many of these are "silent ruptures," detectable only through imaging like an MRI, meaning patients may be unaware that free silicone gel is present in their body. One study of explanted devices found a staggering rupture prevalence of 55%.

Traditionally, removing a ruptured implant is a meticulous and often messy process. Surgeons must carefully dissect the implant from the surrounding tissue capsule, a task complicated by sticky, free-floating silicone gel. This increases the risk of contaminating the surgical pocket, can extend operating times, and may lead to residual silicone being left behind. In the absence of specialized tools, many surgeons have resorted to improvising with standard operating room equipment, such as large syringes or repurposed bottles, leading to a less controlled and less efficient procedure.

The FDA has acknowledged these risks, mandating "boxed warnings" on all breast implants to inform patients that they are not lifetime devices and that complications, including rupture, are common. The new device from AMT directly addresses the procedural fallout from this known complication.

A Technological Solution for a Cleaner Procedure

The Explant Express® is engineered to streamline this difficult process. The device connects to standard operating room suction systems, allowing a surgeon to rapidly and safely suction the ruptured implant—including both the silicone gel and the shell—out of the body.

"Applied Medical Technology, Inc. is committed to developing practical solutions that address real procedural challenges," said Joe Harr, Surgical Sales Manager for the company, in a statement. "The Explant Express® breast implant suction retrieval device was designed to help plastic surgeons improve efficiency and control when removing ruptured breast implants."

Key features of the device are designed to maximize both safety and efficiency:

• Contained Retrieval: The suction-based system is designed to contain the silicone gel and shell fragments during removal, drastically reducing the risk of spillage and contamination of the surgical field.
• Ergonomic Design: It features a no-slip, ergonomic handle to give surgeons superior control during the delicate procedure.
• Post-Procedure Inspection: A unique separable chamber allows the surgeon to easily inspect the retrieved material after the procedure, ensuring the entire implant has been removed.
• Universal Compatibility: The device is designed to be compatible with a wide range of breast implant sizes, making it a versatile tool for any plastic surgeon's arsenal.

By creating a closed system for removal, the Explant Express® promises to reduce operating time, maintain a cleaner surgical field, and provide surgeons with greater confidence during a complex procedure.

Patient Safety and the Growing Demand for Explantation

The launch of this device is particularly timely, as it coincides with a significant increase in patient awareness and advocacy related to breast implant safety. A growing movement of patients reporting a collection of systemic symptoms, often termed Breast Implant Illness (BII), has led to a surge in the number of women seeking to have their implants removed.

For these patients, the primary goal is not aesthetic but therapeutic—to improve their health and well-being. The integrity of the explantation procedure is therefore paramount. Concerns over incomplete removal or silicone contamination are major sources of anxiety. A tool that promises a cleaner, more thorough removal directly addresses these patient concerns, potentially offering greater peace of mind.

Patient advocacy groups have been instrumental in pushing for safer practices and more comprehensive explant techniques, such as total capsulectomy (removal of the implant and the entire scar tissue capsule surrounding it). While the Explant Express® focuses on the implant itself, its ability to prevent silicone spillage is a critical component of a clean and effective capsulectomy, aligning with the goals of both surgeons and patient advocates who prioritize long-term health outcomes.

A Strategic Move in an Evolving Market

For Applied Medical Technology, a company with a 40-year history in medical devices, the Explant Express® represents a shrewd strategic move into a high-need niche. The global market for plastic surgery devices is expanding rapidly, but AMT is not simply chasing growth; it is providing a solution to a specific, unmet need.

While at least one other suction-based removal device exists, the field is far from crowded, and many surgeons still lack access to such specialized tools. The Explant Express®, which recently received FDA 510(k) clearance, is positioned for easy adoption. Its compatibility with existing OR suction equipment means hospitals and surgical centers can integrate it into their workflow without investing in new capital equipment or extensive training.

Clinical data on similar innovative devices has been promising. A recent prospective clinical trial published in a peer-reviewed journal, which evaluated a device with a strikingly similar mechanism, reported a mean extraction time of just 10.7 seconds with no complications. Surgeons involved in the study expressed a very high intention to adopt the technology in their practice, underscoring the perceived value of such a tool.

By launching the U.S.-manufactured Explant Express®, AMT is poised to capture a significant share of the growing explant market. This focus on targeted, accessible innovation highlights a significant shift in the medical device industry toward addressing specific procedural pain points and improving patient outcomes in established surgical fields.