Patients undergoing breast reconstruction often need further MRI scans to screen for tumour recurrence. Image credit: Shutterstock/H_Ko.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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.

The Motiva Flora expander received CE marking in June 2020, with the company rolling out the implant commercially in early 2021.

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.