The US Food and Drug Administration (FDA) has cleared Establishment Labs’ tissue expander for breast reconstruction surgery.
In a statement announcing the news, the US-headquartered company said the magnet-free nature of its Motiva Flora SmoothSilk Tissue Expander means it does not interfere when undergoing magnetic resonance imaging (MRI). Patients undergoing breast reconstruction often need further MRI scans to screen for tumour recurrence.
The FDA labelled the implant as MR conditional, which allows the device to be used in scanners under certain conditions and only when precautions are taken.
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Most traditional tissue expanders use magnetic ports as a point of entry to fill the implant with liquid. These expanders are labelled MR unsafe. Establishment Labs developed its port without magnets to allow MRI scans to progress unhindered.
The Motiva Flora expander received CE marking in June 2020, with the company rolling out the implant commercially in early 2021.
Establishment Labs has conducted a multi-centre study that demonstrated that patients with the Flora implant did not produce lower-quality images, in addition to proving MRI-related safety.
