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.
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.
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.
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MRI Safety director and University of Southern California professor of radiology and medicine Dr Frank Shellock said in the company statement: “The technology used by the Flora SmoothSilk Tissue Expander that enabled it to be labelled MR Conditional will have a critical impact on patients during their breast reconstruction journey, permitting them to undergo MRI, the most important diagnostic imaging modality.”
In addition, Establishment Labs pointed to a blinded head-to-head study where patients reported higher aesthetic and comfort scores and less breast pain compared to an unnamed commercially available expander.
GlobalData placed the global breast implant market at $2bn in 2022. The market is expected to grow to $2.6bn by 2033, with expanders predicted to contribute nearly $300m. GlobalData reports that Establishment Labs occupies a 2.7% global market share.