
Unleash Your Confidence
Schedule a Consultation
Contact Us

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.
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.
|
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Withdrawn, 2019 recall |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 |
“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.
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.
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.
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.
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.
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.
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.
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.
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.
