Breast Implant Manufacturers in the US (2026): FDA-Approved Guide

For plastic surgeons. Updated October 2, 2026 · Prepared by Prospyr. Prospyr makes practice software for plastic surgery and aesthetic practices, not breast implants, and none of the companies below is a Prospyr product or partner. This is a reference guide, not a ranking. The list of approved devices comes from the U.S. Food and Drug Administration (FDA), and each company summary reflects the manufacturer's own website, checked October 2026. Product availability, warranties and labeling change, so confirm current terms with your sales representative and the device's labeling before you order.

Which breast implant manufacturers are FDA-approved?

Five companies currently make breast implants on the FDA's list of approved breast implants: Allergan Aesthetics (Natrelle), Mentor (Johnson & Johnson MedTech), Sientra (now owned by Tiger Aesthetics Medical), Establishment Labs (Motiva) and Bimini Health Tech (the Serene implant, formerly IDEAL IMPLANT). Allergan and Mentor make both saline and silicone gel implants. Sientra and Motiva make silicone gel implants. Serene is a structured saline implant. The FDA lists each approved product by premarket approval (PMA) number, with its labeling and post-approval study status.

The 5 FDA-approved breast implant manufacturers at a glance

How we chose this list

This guide has one inclusion rule: the company must make a breast implant on the FDA's page of approved breast implants (content current as of February 6, 2025, checked October 2026). We then loaded each manufacturer's own website to confirm the company and product names, the parent company, and any published warranty terms.

• FDA approval first. Devices approved outside the US, or still under clinical investigation in the US, are not included.
• Current owner. Two product lines have changed hands. The FDA notes that Sientra is now owned by Tiger Aesthetics Medical and that IDEAL IMPLANT is now the Serene implant.
• Published terms only. We report warranty terms only where the manufacturer publishes them.
• No safety or outcome claims. We do not compare complication rates. Use each device's FDA labeling and core study data for that.

Companies are listed alphabetically. The order is not a ranking or a measure of results.

1. Allergan Aesthetics (Natrelle)

Allergan Aesthetics, an AbbVie company, makes Natrelle breast implants alongside BOTOX Cosmetic, the JUVÉDERM collection, KYBELLA and CoolSculpting. The FDA list includes three Allergan products: Inamed (now Allergan) saline implants (P990074), Natrelle silicone gel-filled implants (P020056) and Natrelle 410 highly cohesive anatomically shaped silicone-filled implants (P040046).

What stands out:

• Range. Allergan describes Natrelle as offering "the largest selection" of smooth breast implants, with five profile options and three gel types.
• Surgeon resources. It runs a surgeon site (natrellesurgeon.com) and connects Natrelle to its Allē loyalty program.
• Recall history. The FDA notes that in July 2019 Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders, and that smooth implants were not affected.

Right for: practices that already buy Allergan injectables and want one account relationship. Ask: current warranty terms in writing, which textured options remain available, and how Allē works with implant patients.

2. Bimini Health Tech (Serene, formerly IDEAL IMPLANT)

Bimini Health Tech is a privately held medical device company in Plano, Texas that makes the Serene Breast Implant, a structured saline implant. The FDA lists it as "IDEAL IMPLANT Saline Breast Implants (Now Puregraft Serene Breast Implant)" under PMA P120011. Bimini states the Serene implant "builds upon the foundation of the former Ideal Implant."

What stands out:

• Design. Bimini describes dual chambers with nested baffle shells that control saline movement and reinforce the implant edges.
• Warranty. It advertises a limited lifetime warranty, with full terms in the Instructions for Use.
• Device tracking. Its product page links a Serene device tracking form.

Bimini also makes Puregraft fat grafting systems and other plastic surgery products.

Right for: surgeons who want a saline option beyond standard single-lumen saline implants. Ask: how supply has worked since the product moved from IDEAL IMPLANT to Bimini, and what the warranty excludes.

3. Establishment Labs (Motiva)

Motiva, from Establishment Labs, makes two silicone gel implants on the FDA list: Motiva SmoothSilk Round and Motiva SmoothSilk Round Ergonomix (P230005, with labeling dated 2024 and a 3-year core study follow-up). Motiva's US site states both have FDA premarket approval for augmentation and are commercially available in the US, and that Motiva implants for reconstruction "are not yet commercially available in the US and are undergoing clinical investigation."

What stands out:

• Augmentation only for now. Check the indication before you plan a reconstruction case.
• Warranty programs. Motiva advertises first-year free coverage plus 2-year and 5-year Motiva programs, tied to registering the implants. Program details are not on the homepage.
• Tissue expander. It also markets Motiva Flora, a tissue expander.

Right for: augmentation practices that want to offer a newer silicone gel option. Ask: the full terms and cost of each warranty program, and how patients register.

4. Mentor (Johnson & Johnson MedTech)

Mentor, part of Johnson & Johnson MedTech, makes the most product lines on the FDA list: Mentor saline implants (P990075), MemoryGel silicone gel implants (P030053), MemoryShape silicone gel implants (P060028) and MemoryGel Enhance (P030053/S069). Its product page also lists MemoryGel Xtra.

What stands out:

• Large reconstruction sizes. Johnson & Johnson announced FDA approval of MemoryGel Enhance in December 2024 for primary and revision reconstruction, in sizes from 930 cc to 1445 cc. The previous maximum was 800 cc.
• Made in the USA. Mentor states its MemoryGel implants are made in the US.
• Surfaces. MemoryGel comes in smooth and textured shells.

Right for: practices doing both augmentation and reconstruction that want one supplier across saline, round gel and shaped gel. Ask: current warranty terms in writing, MemoryGel Enhance availability, and lead times.

5. Sientra by Tiger Aesthetics

Sientra implants are now made by Tiger Aesthetics Medical, which the FDA lists as the owner of Sientra OPUS silicone gel breast implants (P070004). Sientra advertises 200+ implant options across six profile levels, two surface options and two high-strength cohesive gel types.

What stands out:

• Published warranty amounts. As of October 2026, Sientra advertises a 20-year warranty that includes lifetime free implant replacement for rupture, up to $5,000 toward rupture-related fees, up to $7,500 for BIA-ALCL-related care, and replacement for capsular contracture (Baker Grade III/IV) and late seroma.
• Related products. Tiger Aesthetics also owns other brands, including Viality and AlloX2.

Right for: practices that want warranty terms in hand before a sales call. Ask: the conditions and claim steps behind each warranty amount, and how the change in ownership affects your account and ordering.

Questions to ask any breast implant manufacturer

1. What is the approved indication? Confirm augmentation, reconstruction and revision approvals for the exact product, and the minimum patient age for augmentation (18 for saline, 22 for silicone gel, per the FDA).
2. Where is the current labeling? The FDA approved new labeling in October 2021 that includes a boxed warning, a patient decision checklist, rupture screening recommendations for silicone gel implants and a patient device card. Make sure your team uses the current version.
3. What does the warranty cover in writing? Ask for exclusions, time limits, dollar caps and who files the claim.
4. How does device tracking work? Ask what the practice must submit after each case and how patients register their implants.
5. What are lead times and return terms? Ask about consignment, sizer availability and returns on unopened implants.
6. How do you report adverse events? Know the manufacturer's reporting line and how your team reports problems to the FDA.

Where Prospyr fits

The FDA requires that the patient decision checklist be reviewed with each patient, that the patient be given the chance to initial and sign it, and that the implanting physician sign it. Your practice also needs a reliable record of consults, consent and follow-up visits. Prospyr's digital intake collects patient forms before the visit, and our page for plastic surgery practices shows how consults, surgery booking and follow-up fit together. Book a practice demo.

For more on consent, see informed consent in aesthetic surgery. If you are building out your surgical team or facility, see our lists of plastic surgery patient coordinator training, ASC management companies and sterilization and instrument services.

Frequently asked questions

How many breast implant manufacturers are FDA-approved?

Five companies make the breast implants on the FDA's approved list: Allergan Aesthetics, Mentor, Sientra (Tiger Aesthetics Medical), Establishment Labs (Motiva) and Bimini Health Tech (Serene). Check the FDA's page of approved breast implants for the current list, since products and owners change.

Is Motiva FDA-approved for breast reconstruction?

Not yet. Motiva's US site states its SmoothSilk Round and Ergonomix implants are approved for augmentation, and that its implants for reconstruction are not yet commercially available in the US and are under clinical investigation.

Who makes Sientra breast implants now?

Tiger Aesthetics Medical. The FDA lists Sientra OPUS silicone gel breast implants as "now owned by Tiger Aesthetics Medical," and the Sientra website carries the "Sientra by Tiger Aesthetics" name.

What happened to the IDEAL IMPLANT?

It is now the Serene Breast Implant. The FDA lists the IDEAL IMPLANT as now the Puregraft Serene Breast Implant, made by Bimini Health Tech in Plano, Texas, which states Serene builds on the former IDEAL IMPLANT.

Do breast implants last a lifetime?

No. The FDA states that breast implants are not lifetime devices and that patients should assume they will need additional surgeries. Allergan and Mentor make the same point on their product pages, so include it in your consult and consent process.

Want your company considered?

We review this guide quarterly. Companies that make FDA-approved breast implants or serve plastic surgeons can send their website and what they offer practices to info@prospyrmed.com. Inclusion is editorial and not paid.

Editorial scope

This guide is based on the FDA's public breast implant pages and each manufacturer's public website, checked October 2026 with AI-assisted research. Manufacturers did not review this article before publication. It is not medical advice, a comparison of device safety or outcomes, or a substitute for each device's FDA-approved labeling. Read our methodology or report a correction.