Motiva implants at Yanhee: the safety data, the technology and the cost

What Motiva implants are

Motiva Implants are silicone gel breast implants made by Establishment Labs, a Costa Rican medical device company that manufactures nothing else. The design reworks the shell surface, the gel, the shell construction and the identification markers rather than adjusting one of them. Nearly four million devices have been delivered to surgeons in more than 85 countries since 2010.

Yanhee International Hospital offers Motiva alongside other FDA-approved implants, including Mentor. Implant line, size and placement are chosen at consultation.

What the safety data says

Motiva is usually asked for by name because of its published complication rates. Three separate bodies of evidence exist, and they measure different things, so the numbers are not interchangeable.

Post-market surveillance, 2011 to 2023

Establishment Labs reports adverse events as a percentage of implants sold. Across more than 3.2 million implants between January 2011 and September 2023:

Read these as reporting rates, not as clinical incidence. A complication only appears here if someone reported it to the manufacturer, which is why the figures sit so far below what a followed-up trial finds. The registry numbers are a useful check: of 354,000 women who registered their implants in the MotivaImagine app, 427 (0.46%) reported a device-related complication that led to a second operation.

The US FDA trial

The Motiva IDE study ran at 32 centres in the United States and three in Western Europe, with 92.4% patient compliance at the three-year endpoint. These are Kaplan-Meier risk rates by patient for the primary augmentation cohort of 451 women:

The 8.4% figure is the honest one to plan around. Capsular contracture and rupture, the two failures that worry patients most, both came in under 1%, but roughly one woman in twelve had some complication within three years and about one in sixteen had a further operation. Most of those reoperations were elective size changes rather than device failures.

On the strength of this study the FDA approved Motiva SmoothSilk Round and SmoothSilk Ergonomix for primary and revision breast augmentation on 26 September 2024. It was the first new breast implant premarket approval the FDA had granted since 2013. The reconstruction indication is still under clinical investigation in the United States.

Independent registry and published studies

Sweden's national breast implant registry followed more than 8,000 Motiva implants for six years after implantation and recorded a reoperation rate below 1% for device-related complications. Twenty-seven independent peer-reviewed publications cover Motiva in aesthetic surgery, with follow-up between six months and six years. The longest of them, Chacón and colleagues in the Aesthetic Surgery Journal in 2018, followed 35 patients for six years with MRI assessment and found no capsular contracture and no rupture.

Figures on this page come from Establishment Labs' Q3 2023 post-market surveillance report and its September 2024 FDA approval announcement.

How Motiva compares with older implants

Motiva's three-year capsular contracture and rupture rates are lower than those reported in the FDA core studies that supported earlier implant approvals. That comparison has a limit worth stating plainly: these are separate trials run at different times under different protocols, not a head-to-head. No trial has randomised patients between Motiva and a competitor implant. Treat the gap as context rather than proof, and ask your surgeon what they see in their own revision rates.

The technology, part by part

SmoothSilk / SilkSurface controlled surface

The shell surface is produced by 3D nanotechnology imprinting, without the salt or sugar crystals used to texture older implants, giving a controlled micro-nano arrangement. Establishment Labs designed it for biocompatibility and low inflammatory response, and the FDA approval statement describes the surface as scientifically shown to promote low inflammation. A smoother, thinner shell also inserts through a smaller incision.

Viscoelastic silicone gel

Motiva uses a silicone gel tuned for viscosity and elasticity. The Ergonomix line is built around this: the implant holds a round shape lying down and a teardrop shape standing up, which is where the name comes from. Motiva SmoothSilk Round keeps a round form in either position with more upper-pole fullness.

TrueMonobloc shell

TrueMonobloc bonds the shell, the gel and the patch into one unit rather than layering them. Establishment Labs reports mechanical performance meeting or exceeding regulatory standards on break force, tear resistance, tensile set and patch-joint integrity. In practice this is what allows a soft gel to be pushed through a small incision without damaging the shell.

BluSeal barrier-layer indicator

BluSeal tints the implant's barrier layer blue so the surgeon can see it is intact and continuous before placing the implant. The barrier layer is what stops silicone gel diffusing through the shell into surrounding tissue, and on a clear shell there is no way to inspect it. This is a quality-control step built into the device rather than a feature the patient experiences.

Qid RFID identification

Qid, also written Q Inside Safety Technology, is an FDA-cleared RFID microtransponder embedded in the implant and readable from outside the body with a handheld scanner. It carries a unique device identifier tied to your record in the MotivaImagine app. If a safety notice or recall is ever issued, the serial number of what is actually in you can be confirmed without surgery or paperwork. Qid also determines which extended warranty you are eligible for.

The warranty

Every Motiva implant carries two standing cover programs at no cost. The Always Confident Warranty replaces a ruptured implant free of charge for the lifetime of the device. The Product Replacement Policy replaces an implant free of charge in the event of capsular contracture at Baker grades III or IV, for 10 years from the first implantation. Both cover the device only, not the surgery to put it in.

Two paid extended programs add money toward that surgery. You have 90 days from your operation to register the implants and enrol.

Assistance applies to one revision surgery, for a claim of rupture or capsular contracture at Baker grades III or IV. The exclusions matter as much as the cover: nothing applies to removal of an intact implant for a size change, for rippling, or for Baker grade I or II contracture, and nothing applies to a revision patient who had capsular contracture with another brand of implant before switching to Motiva. Rupture claims require the explanted device to be returned to Establishment Labs within 10 days.

Warranty terms are Establishment Labs', not Yanhee's, and are published in USD by the manufacturer. Confirm current terms on the Motiva product warranty page before relying on them.

Motiva implant prices at Yanhee

Yanhee quotes Motiva by implant line, each with a one-night hospital stay. Motiva sits above the hospital's Mentor round packages, which start at 125,000 THB, so the premium for the surface technology and the warranty runs from roughly 32,000 THB upward.

The package covers the surgeon, the anaesthesia, the implants, the stated hospital stay, pre-operative tests and post-operative care; international flights and accommodation beyond the stated night are not included. Prices are subject to change and are confirmed after consultation — see plastic surgery prices for the current list, or the main breast augmentation page for the Mentor, Sebbin and Silimed options.

Frequently asked questions

Available doctors

These plastic surgeons at Yanhee perform breast augmentation with Motiva implants. Your surgeon is confirmed at consultation.