Motiva breast implants are FDA-approved, which means that they've been evaluated for safety through years of clinical trials.
All Motiva implants have BluSeal safety technology, an advanced barrier layer around the silicone gel that helps prevent leaks.
Their SmoothSilk Surface was designed for enhanced biocompatibility. The makers of Motiva implants point to the low inflammation and bacterial attachment rates of the SmoothSilk Surface as underlying reasons for their "industry low .05% capsular contracture rate and no device related proliferative diseases, such as BIA-ALCL." (Breast implant–associated anaplastic large-cell lymphoma, or BIA-ALCL, is a rare type of cancer associated with more highly textured implants. There have been no reported cases of BIA-ALCL with Motiva implants.)
A retrospective study of 5,813 Motiva patients published in the Aesthetic Surgery Journal in 2017 concluded that "Motiva silicone breast implants are associated with very low rates of complication and reoperation, and that the SmoothSilk surface implant is associated with fewer complications than micro-textured implants."
In 2020, the manufacturers of Motiva implants reported that their 10-year post-market surveillance data demonstrates a complication rate of less than 1% "for the key safety endpoints of capsular contracture and implant rupture, with nearly 1.3 million breast implants placed worldwide outside of the United States." More recent studies showed even lower complication rates: 0.5% for capsular contracture, 0.6% for rupture, and 0.9% for infection.
A 2021 study sponsored by Motiva and conducted by researchers at MIT (who are also stakeholders in the company) showed that the SmoothSilk surface significantly reduces the foreign body response, compared to implants with high degrees of roughness or completely smooth surfaces, making it more biocompatible.
The researchers also found that tissue capsules of patients with traditional smooth or highly textured implants were notably thicker and less healthy, compared to capsules of patients with Motiva SmoothSilk implants. This study demonstrated that SmoothSilk implants aren't only less harmful, but may actually protect against inflammation.
However, a 2023 review and meta-analysis exploring complication rates with Motiva SmoothSilk implants stresses that more well-designed, large-scale, multicenter, prospective case-control studies with longer follow-ups are needed to accurately gauge post-op complication rates, since most current studies in the literature are retrospective and prone to bias and other limitations (small samples, lacking control groups, limited follow-up periods).
“The results of manufacturer-sponsored studies should be interpreted with caution,” the authors state. “Eight of the thirteen (62%) studies included in this manuscript, either had funding from device manufacturers or one or more authors had a financial relationship with manufacturing companies.”
All breast implants are not lifetime devices and may need to be removed, updated, or replaced as they age. Learn more about breast implant safety.
