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Marrying Clinical Data with Science: Our Approach to Next-Generation Breast Implants

Blog Post May 27, 2020 post.reading-time

While silicone breast implants have been around since the 1960s, they’ve experienced little technological evolution in the past three decades until the 2010s.

Meanwhile, women around the world face increasing news coverage of breast implant-related side effects – most of which have been linked to one particular implant surface – the macrotextured kind.

But despite mounting evidence that macrotextured implants potentially trigger inflammatory conditions in patients, leading implant manufacturers continue to manufacture, market, and sell 4th and 5th generation implants that haven’t significantly changed since the 1980s.

Such conditions can range from common, low-risk capsular contracture (which is when the natural tissue capsule formed around an implant hardens and contracts) to a form of cancer known as breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.

In the face of competitors’ complacency, Establishment Labs has sought to make women’s health the focus that drives how implants are designed and manufactured.

We’ve teamed up with the best research-focused institutes and universities – along with the world’s most innovative plastic surgeons – to diligently investigate an under-researched subject: breast implant surfaces, and the ways our immune systems can respond to them.

Our research on implant technologies began a decade and a half ago in 2004. While other manufacturers base their development process almost purely on clinical data, we’ve taken a more holistic approach, basing our 6th generation implant technology on both clinical and scientific research.

You might be wondering what the differences between the two are, and how they matter when it comes to making implants with minimal side effects.

Clinical research involves strictly controlled studies of new and emerging treatments in real human patients. It allows doctors to evaluate new forms of treatment, determine how best to apply them in medicine, and provide patients with opportunities to receive the latest, state-of-the-art care.

Basic scientific research, however, is performed in laboratory conditions using beakers and test tubes, not people. Investigators research microscopic phenomena – at the cellular and molecular level of life – to better understand the macroscopic phenomena that occur in humans, such as diseases and disorders.

Our research informed us early on of the inflammatory effects of macrotextured implants, which is why we never chose to make them to begin with. Instead, we’ve focused on creating our biocompatible advanced smooth surface, along with other features that help keep patients safe and beautiful.

Motiva Implants® were designed specifically to minimize the body’s inflammatory reactions – and thus, the conditions associated with them.

More than a million Motiva Implants® have been used by patients and leading plastic surgeons throughout the 2010s across the globe. Both clinical and scientific publications as well as post-market implant surveillance show that patients with Motiva Implants® experience an overall complication rate of less than 1%.

Learn more about our advanced smooth surface and unique safety features here.

*Motiva Implants® are not available for sale in US and Canada.


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[1] The information provided is for informational and educational purposes only, the content herein is not intended as a substitute for consultation with a physician. Motiva® Implants are not yet commercially available in the US and are undergoing clinical investigation pursuant to US Food and Drug Administration (FDA) regulations for investigational medical devices.
[2] The statements and opinions presented here are applicable to each individual. Results will vary and may not be representative of the experience of others. All statements are voluntarily provided and are not paid, nor were they provided with free products, services, or any benefits in exchange for said statements. The statements are representative of patient experience; the exact results and experience will be unique and individual to each patient.