Medically reviewed by Mark D. Epstein, MD, FACS. Last updated: July 9th, 2026.
Next scheduled review: October 9th, 2026.
Motiva SmoothSilk implants are among the most thoroughly studied breast implants ever brought to the US market. The FDA approved the Motiva SmoothSilk Round and Ergonomix implants in September 2024 after a clinical trial that followed hundreds of patients for years, showing a capsular contracture rate of 0.5%, a rupture rate of 0.6%, and zero cases of BIA-ALCL. More than 4.5 million Motiva implants are in use worldwide with no confirmed cases of BIA-ALCL reported to date.2
I can walk you through this data with an insider's view, because I served as a Principal Investigator in the Motiva FDA clinical trial and enrolled patients at my Hauppauge, New York practice. Disclosure: as a trial investigator I worked directly with Establishment Labs, the manufacturer, and I am compensated for training other surgeons in Motiva techniques. You deserve to know that, and you also deserve the actual numbers.
What did the FDA clinical trial show?
The 10-year clinical trial follows primary augmentation and revision patients with standardized examinations and a substudy with MRI surveillance. The published, mid study results reported capsular contracture of 0.5% in primary augmentation, a rupture rate of 0.6%, and patient satisfaction of 97% at five years.1 For context, historical reoperation rates for earlier FDA-approved silicone implants ran 15.4% (Mentor at 3 years) to 24.5% (Allergan at 4 years) at comparable time points; the Motiva trial reported 8.8% at five years.1
Do Motiva implants cause BIA-ALCL?
BIA-ALCL, a rare lymphoma of the capsule around an implant, is overwhelmingly associated with heavily textured implant surfaces in the 40 to 90 micron range.3 Motiva's SmoothSilk surface averages about 4 microns,4 and to date there are no confirmed cases of BIA-ALCL2 in Motiva implants across more than 4.5 million implants on the market.3 No manufacturer can promise a zero future risk, but the surface science and the track record are the reasons I chose to participate in this trial.
What about breast implant illness (BII)?
Some patients report systemic symptoms such as fatigue, joint pain, or brain fog that they attribute to their implants. The FDA notes these reports occur with every implant type, and there is currently no diagnostic test for BII.5 I take it seriously rather than dismissing it. What I can tell you is that Motiva's design aims to reduce the inflammatory response4 around the implant, and that any patient of mine who develops concerning symptoms has a direct line to me for evaluation, including explant if that is her choice.
How long do Motiva implants last?
No implant is a lifetime device. Plan on the possibility of another operation at some point, typically 10 to 15 years or more down the road, and replace implants only if a problem develops, not on a calendar schedule. Routine imaging surveillance per FDA guidance is how we watch for silent rupture.6
Is anyone still studying these implants?
Yes. The FDA requires a 10-year post-approval study tracking long-term complication rates, rare events, and patient satisfaction.7 Independently, a 2023 meta-analysis covering nearly 5,000 patients reported an overall complication rate of 5.2%.8 The evidence base is still growing, which is exactly how it should work.
Frequently Asked Questions
Are Motiva breast implants FDA approved?
Yes. The FDA approved Motiva SmoothSilk Round and SmoothSilk Ergonomix implants in September 2024 for breast augmentation and revision augmentation in women 22 and older. The approval was supported by data from the prospective, multicenter Motiva U.S. IDE clinical trial conducted across sites in the United States and Europe.
Has BIA-ALCL ever been reported with Motiva implants?
As of this writing, no confirmed cases of BIA-ALCL have been reported with Motiva implants across more than 4.5 million implants in use worldwide.2 The SmoothSilk surface avoids the aggressive texturing most strongly linked to BIA-ALCL.3
What is the rupture rate for Motiva implants?
The FDA trial reported a rupture rate of 0.6%, with capsular contracture of 0.5% in primary augmentation patients.1 These are among the lowest figures reported for any FDA-approved silicone implant at comparable follow-up.
How do you know this data is trustworthy?
The trial data was collected under FDA oversight with independent monitoring, and it is published in peer-reviewed literature.1 I served as a Principal Investigator in the trial, so I saw the process firsthand, and I disclose that relationship openly.
Sources
- FDA approval of Motiva SmoothSilk implants (September 2024): https://support.motiva.health/hc/en-us/articles/4408682762643-Are-Motiva-Implants-FDA-approved
- Motiva FDA trial clinical data, Aesthetic Surgery Journal (2024): https://academic.oup.com/asj/article/44/12/1273/7781437 (free full text: https://pmc.ncbi.nlm.nih.gov/articles/PMC11565863/)
- Meta-analysis of complication rates in 4,784 Motiva patients (2023): https://pmc.ncbi.nlm.nih.gov/articles/PMC10004118/
- Motiva USA official product and labeling information: https://motivausa.com
- Caroline Glicksman, Andrew Wolfe, Patricia McGuire, The Study of the Safety and Effectiveness of Motiva SmoothSilk Silicone Gel-filled Breast Implants in Patients Undergoing Primary and Revisional Breast Augmentation: 5-Year Clinical Data, Aesthetic Surgery Journal, Volume 46, Issue 3, March 2026, Pages 319–328, https://doi.org/10.1093/asj/sjaf245
- Establishment Labs. 2025 Post Market Surveillance report: Motiva Implantable Devices. 2025 PMS Report – Establishment Labs
- Clemens, Mark W. MD, MBA1; Myckatyn, Terence M. MD2; Di Napoli, Arianna MD3; Feldman, Andrew L. MD4; Jaffe, Elaine S. MD5; Haymaker, Cara L. PhD1; Horwitz, Steven M. MD6; Hunt, Kelly K. MD1; Kadin, Marshall E. MD7; McCarthy, Colleen M. MD6; Miranda, Roberto N. MD1; Prince, H. Miles MD, PhD8; Santanelli di Pompeo, Fabio MD, PhD3; Holmes, Sari D. PhD9; Phillips, Linda G. MD10. American Association of Plastic Surgeons Consensus on Breast Implant–Associated Anaplastic Large-Cell Lymphoma. Plastic and Reconstructive Surgery 154(3):p 473-483, September 2024. | DOI: 10.1097/PRS.0000000000011370
- Doloff JC, Veiseh O, de Mezerville R, et al. The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans. Nature Biomedical Engineering. 2021. doi:10.1038/s41551-021-00739-4
- Center for Devices and Radiological Health. (2025, February 6). Medical Device Reports for Systemic Symptoms in Women with Breast Implants. U.S. Food And Drug Administration. https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-systemic-symptoms-women-breast-implants
- Center for Devices and Radiological Health. (2023, December 15). Breast implants. U.S. Food And Drug Administration. https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants
- Center for Devices and Radiological Health. (2025a, February 6). Breast implant Postmarket safety information. U.S. Food And Drug Administration. https://www.fda.gov/medical-devices/breast-implants/breast-implant-postmarket-safety-information#evaluation
- Aitzetmuller-Kleitz ML, Yang S, Wiebinghaus P, Wellenbrock S, Ozturk M, Kuckelhaus M et al. Complication rates after breast surgery with the Motiva Smooth SilkSurface silicone gel implants - A systematic review and meta-analysis. Clin. Med. 2023, 12,1881. doi: 10.3390/jcm12051881
Sections - Motiva Breast Implants
- What is the Motiva Breast Implant?
- Are Motiva Implants Safe? FDA Data Explained by a Trial Investigator
- Motiva Ergonomix vs. Round: A Surgeon's Guide to Choosing
- Ergonomix vs Round: Breast Shape and Movement
- Dr. Epstein’s Eight Year Motiva Experience
- What Makes the Motiva Implant Different?
- Motiva – Is it Smooth or Textured?
- Motiva vs Other Implants
- How Motiva Implants Are Different from Allergan Natrelle, Mentor and Sientra Implants
- MOTIVA US Clinical FDA Trial
Prev Chapter: Preservation Breast Augmentation – A New Era! »
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Chapters – Breast Augmentation Guide
- Intro to Breast Augmentation
- Preservation Breast Augmentation – A New Era!
- Motiva Implants – What You Need to Know
- Five key decisions you need to make
- One-Day Recovery Breast Augmentation
- Anesthesia – General, Sedation or Local?
- Breast Lift (Mastopexy) with/without Implants or Fat
- What else should I know about breast augmentation?
- Important Things to Consider When You Decide to Move Forward With Breast Augmentation
- Revision of breast augmentation
- ALCL and Breast Implant Illness
