Medically reviewed by Mark D. Epstein, MD, FACS. Last updated: August 13, 2026
This is one of the most common questions patients ask about Preservé, and much of what is published online gets it wrong. Some websites describe the procedure as "FDA approved." Others claim it is not yet available in the United States. Neither is accurate. As a Principal Investigator in the Motiva U.S. FDA clinical trial, Dr. Mark Epstein can explain exactly what the FDA has and has not approved.
The Short Answer
Preservé is a surgical technique, and the FDA approves devices, not techniques. No surgeon can accurately claim that the Preservé procedure itself is "FDA approved" or "FDA cleared." What the FDA does regulate are the products used in the procedure, and those fall into two categories:
- The Motiva Ergonomix breast implants used in Preservé received full FDA approval in September 2024, following a multi-year U.S. clinical trial.
- The specialized Preservé instruments are Class I surgical instruments, registered and listed with the FDA. Registration and listing is the only FDA requirement for that device class; no clearance or approval process applies to Class I surgical instruments.
So when a website says "Preservé is FDA approved," that is a shortcut that blurs an important distinction. The implants are FDA approved. The instruments are FDA registered and listed. The technique itself is not something the FDA reviews, for Preservé or for any other surgical method.
Why This Distinction Matters
If a practice describes the procedure itself as FDA approved, that tells you something about how carefully its information is prepared. The FDA framework exists to evaluate the safety of devices such as implants. The quality of a surgical technique depends on something the FDA does not measure: the training, judgment, and experience of the surgeon performing it.
That is why the more useful questions for a patient considering Preservé are about the surgeon: Has the surgeon completed in-person Preservé training? How many Preservé cases has the surgeon personally performed? Was the surgeon involved with Motiva implants before their U.S. approval?
The FDA Evidence Behind the Motiva Implants
The Motiva Ergonomix and SmoothSilk Round implants were approved by the FDA in September 2024 on the strength of a U.S. clinical trial that followed patients for years at multiple sites. Dr. Epstein served as a Principal Investigator in that trial. According to Motiva data provided to Dr. Epstein, he was the highest-enrolling investigator, with 73 patients enrolled, and he continues as an investigator in the Motiva Post-Approval Study, which collects long-term safety and effectiveness data.
Because of that trial role, Dr. Epstein began working with Motiva implants in 2018, approximately six years before FDA approval. Patients who want the underlying safety data can review it on our page covering the Motiva FDA results.
What About the Preservé Instruments?
Preservé uses dedicated single-use instrumentation to expand the implant pocket gently rather than cutting it. These instruments are Class I surgical instruments. Under FDA rules, Class I surgical instruments must be registered and listed with the agency, and these are. Class I devices do not go through premarket approval or 510(k) clearance, so claims that the instruments are "FDA cleared" are also inaccurate. Dr. Epstein designed Preservé instrumentation, including a specialized channel dilator that prepares the narrow tissue channel used during implant placement.
Frequently Asked Questions
Schedule a Consultation
If you are considering Preservé breast augmentation and want your questions answered directly by a Motiva FDA trial investigator, schedule a consultation with Dr. Epstein in Hauppauge, Long Island.
Disclosure: Case volume, national volume ranking, and trial enrollment figures are based on Motiva data provided to Dr. Epstein by Establishment Labs, the manufacturer of Motiva implants. Dr. Epstein serves as a Motiva clinical trial investigator and Preservé trainer. Current numbers change over time; patients are encouraged to ask for the most current figures during consultation.
Sections - Preserve Breast Augmentation
- Preservé™ Breast Augmentation – A New Era!
- Why choose Dr Epstein for Preservé?
- Same-Day Recovery Breast Augmentation
- Wide Awake Preservé
- Awake Preservé Breast Augmentation: No General Anesthesia
- Preservé Breast Augmentation with a Breast Lift
- Preservé Breast Implant Revision and Replacement
- Dr Epstein training other Preservé surgeons
- New innovation: Epstein Preservé Channel Dilator
- Preservé Breast Augmentation Cost (2026): What Determines the Price
- Is Preservé Breast Augmentation Worth It? Pros, Cons and Limits
Prev Chapter: Intro to Breast Augmentation »
Next Chapter: Motiva Implants – What You Need to Know »
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
