woman speaking with Dr. Firouz about breast implants

Four manufacturers sell FDA-approved breast implants in the United States: Allergan Aesthetics (Natrelle), Mentor Worldwide (MemoryGel, MemoryShape), Sientra (OPUS, now owned by Tiger Aesthetics Medical), and Establishment Labs (Motiva, approved September 2024). No single line is medically superior; the best-rated implant is the one matched to your anatomy and goals.

Which companies make FDA-approved breast implants in the U.S. right now?

Four companies hold FDA premarket approval (PMA) for implants sold here. Allergan Aesthetics (AbbVie) makes Natrelle. Mentor Worldwide (Johnson & Johnson MedTech) makes MemoryGel, MemoryShape, and saline devices in Dallas, Texas.

Sientra’s OPUS line continues under Tiger Aesthetics Medical, which bought the business in April 2024 after Sientra’s Chapter 11 filing (as reported by the American Society of Plastic Surgeons) and kept the Platinum20 warranty.

Establishment Labs is the newest: its Motiva SmoothSilk implants received FDA approval on September 27, 2024, marking the first new implant PMA since 2013.

How do the major implant lines compare on fill, shell, and availability?

Manufacturer

Implant line

Fill and shell

Distinguishing feature

U.S. availability

Allergan Aesthetics

Natrelle INSPIRA (Responsive/SoftTouch/Cohesive)

Silicone gel, smooth

Three cohesivity grades, five profiles

Available

Allergan Aesthetics

Natrelle 410 shaped

Highly cohesive gel, BIOCELL textured

Anatomic teardrop

Withdrawn, 2019 recall

Allergan Aesthetics

Natrelle round saline

Saline, smooth

Adjustable fill

Available

Mentor Worldwide

MemoryGel, Xtra, BOOST

Cohesive gel; smooth or SILTEX textured

Higher gel-fill options

Available

Mentor Worldwide

MemoryShape

Highly cohesive gel, SILTEX textured only

Teardrop, form-stable

Available

Mentor Worldwide

Mentor Saline

Saline, smooth

Corrects asymmetry

Available

Sientra (Tiger Aesthetics)

OPUS round

HSC and HSC+ gel; smooth or textured

Platinum20 warranty; board-certified only

Available

Establishment Labs

SmoothSilk Round, Ergonomix

Silicone gel, SmoothSilk smooth

Augmentation indication only

Available

Ideal Implant

Structured saline

Saline in nested shells

Reduced-rippling design

Discontinued 2023

What does “gummy bear” actually mean?

“Gummy bear” is patient shorthand, not an FDA classification. It means highly cohesive, form-stable silicone gel — cross-linked enough to hold together as a mass rather than flow freely if cut.

When comparing saline vs. silicone implants, cohesivity sits on a spectrum. Allergan grades it openly: Natrelle INSPIRA comes as Responsive (TruForm 1), SoftTouch (TruForm 2), and Cohesive (TruForm 3). Sientra uses HSC gel in round devices, and higher cross-linked HSC+ in shaped ones.

Firmer gel resists rippling and holds upper-pole shape; softer gel moves more naturally but can ripple in thin tissue. Neither end is inherently better.

Are textured breast implants still available after the BIOCELL recall?

Yes, but the category narrowed sharply. On July 24, 2019, Allergan issued a worldwide recall of BIOCELL textured implants and tissue expanders at the FDA’s request (detailed in the FDA BIOCELL recall alert) over BIA-ALCL cases.

BIA-ALCL is a lymphoma of the scar capsule, not breast cancer. The FDA tracks these cases in its medical device reports on BIA-ALCL, while the American Society of Plastic Surgeons publishes updated BIA-ALCL physician resources. It occurs more often with textured shells, though true incidence cannot be calculated from voluntary reports alone.

Mentor’s SILTEX and Sientra’s textured surfaces were not recalled; Natrelle INSPIRA and Motiva are smooth.

Which implant lines are no longer made?

Two products patients still find online are discontinued. The Natrelle 410 relied on BIOCELL texturing and left the market in 2019. Ideal Implant’s structured saline device ended operations on May 30, 2023; as the American Board of Cosmetic Surgery explains, assets went to Bimini Health Tech, and warranties are void. Existing devices remain FDA-approved and need not be removed on that basis alone.

What does the FDA require your surgeon to review before surgery?

Since October 27, 2021, the FDA strengthened safety requirements, restricting implant sales to providers who supply specific risk information: a boxed warning, a patient decision checklist you initial and your surgeon signs, a materials description, and a device ID card.

Updated labeling for approved breast implants carries mandatory rupture screening recommendations: a first ultrasound or MRI 5 to 6 years after placement, then every 2 to 3 years. MRI is preferred if symptoms are present or ultrasound findings are unclear, since most silicone ruptures are silent. (If you suspect a problem, review what happens if a breast implant ruptures.

It also acknowledges systemic symptoms some patients call breast implant illness (BII), as outlined in the FDA's overview of risks and complications of breast implants. Fatigue, joint pain, brain fog, rash, and memory changes are reported, but the remaining causes are still poorly understood. No implant is a lifetime device.

Why should “top-rated” really mean “best-matched”?

Implant selection is a measurement problem: base width, sternal notch-to-nipple distance, pinch-test tissue thickness, asymmetry, and planned pocket narrow the field before the brand enters it.

When considering breast augmentation in Beverly Hills, Dr. Jimmy S. Firouz, a board-certified plastic surgeon, selects across manufacturers rather than defaulting to one catalog — so brand-level questions belong in your consultation.

Warranties differ. All four include lifetime rupture replacement, but financial-assistance windows vary: roughly 10 years for Natrelle, Mentor, and Motiva, versus up to 20 years under Sientra’s Platinum20, which also covers capsular contracture treatment for Baker grade III–IV cases, late seroma, and double capsule.

Frequently Asked Questions

Can I request a specific implant brand for my surgery?

Yes, and it is a fair question. Surgeons stock devices from several manufacturers and order sizes after measuring you. If your preferred line lacks a size and profile fitting your anatomy, your surgeon should explain why an alternative is a better structural match.

Are Motiva implants FDA-approved for breast reconstruction?

Not as of August 2026. Motiva SmoothSilk Round and Ergonomix implants are FDA-approved for primary and revision breast augmentation in women 22 and older. Establishment Labs submitted a breast reconstruction application in late December 2025, and that indication remains under review rather than approved.

What happens to my warranty if the manufacturer stops operating?

Warranties are contracts with the manufacturer, so they can end with the company. Ideal Implant recipients lost coverage after the 2023 shutdown. When Tiger Aesthetics acquired Sientra’s implant business in 2024, it committed to honoring existing Platinum20 terms. Continuity of ownership is worth asking about.

Can I change implant brands during revision surgery?

Yes. A breast augmentation revision is a common point at which patients switch manufacturers, filler types, or shell surfaces, including from textured to smooth. Your surgeon will reassess measurements and capsule condition, since tissue changes may make a different profile or cohesivity level the better fit.


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