FDA Approves Establishment Labs Tissue Expander Technology for Mastectomy Patients
Establishment Labs Holdings Inc. (NASDAQ: ESTA) has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Motiva Flora® SmoothSilk® Tissue Expander. The Motiva Flora® SmoothSilk® Tissue Expander, which has been available in Europe and other global markets since 2021, introduces several innovative features to improve breast reconstruction procedures. One of its most notable attributes is the proprietary SmoothSilk® surface technology, developed by Establishment Labs. Studies have shown that SmoothSilk® leads to the least amount of inflammation and foreign body response when compared to other implant surfaces leading to more comfortable reconstruction outcomes.
A tissue expander is an essential component in breast reconstruction procedures following a mastectomy. This implant is initially empty and is surgically placed during the mastectomy procedure. The tissue expander serves a vital role in the breast reconstruction process. After its placement, a gradual expansion process takes place over approximately 6 to 8 weeks. During this period, the surgeon incrementally fills the expander with either liquid or air. This gradual filling process is essential as it stretches the surrounding tissue, creating the necessary space for a permanent breast implant, which will eventually replace the expander.
In a comparative study where patients received the Flora Tissue Expander in one breast and a U.S. commercially available tissue expander in the other, patients reported significantly higher aesthetic and comfort scores with Flora. They experienced less breast pain, discomfort, and nipple sensitivity, contributing to a better overall patient experience. Surgeons also reported higher satisfaction levels with the Flora Tissue Expander. They observed improved results in lower pole expansion and the footprint created by the device. Furthermore, the capsule tissue around the Flora expander was thinner, and peri-prosthetic fluid levels were significantly lower compared to the comparative device.
Moreover, the Motiva Flora Tissue Expander incorporates an RFID-enabled, non-magnetic port. This unique feature has been designated as “MR Conditional” by the FDA, setting it apart from other breast tissue expanders that typically include magnets. This eliminates the interference that magnetic components can cause during Magnetic Resonance Imaging (MRI) procedures. During the first in-human multi-center study involving patients undergoing 3-Tesla MRI, it was found that Flora did not affect the image quality of the most critical part of the breast MRI protocol. Importantly, there were no MRI-related complications or damage to the expander port. Additionally, for patients undergoing radiation therapy, data was released comparing the dosimetric effect of traditional metallic ports to the RFID port in the Flora Tissue Expander. The study showed superior dosimetric results for the heart and lungs with the potential to reduce side effects for patients undergoing radiation therapy. The Motiva Flora® SmoothSilk® Tissue Expander will now be available to women in the United States.