Implant Brand · 3 of 6
Natrelle / Allergan implants
AbbVie-owned Natrelle implant brand. FDA-approved since 2006. Inspira product family of smooth and microtextured silicone gel implants. Reference includes 2019 BIOCELL recall context.
Brand-neutral information. This page provides factual reference information about this implant manufacturer — products, technology, regulatory status, market position. It does not endorse this brand over alternatives. The right implant brand for you depends on your specific anatomy, surgical priorities, and your surgeon's recommendation. This practice carries multiple brands; selection is based on anatomic fit and patient priorities, not commercial relationships.
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Compare with other brands
See how this brand's profile names, volume increments, and product lines compare to Mentor, Motiva, Polytech, Allergan, Sebbin, and Nagor side-by-side. Translation grid + brand-by-brand catalog breakdown.
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Brand summary
Natrelle (Allergan, now part of AbbVie since 2020 acquisition) is one of three FDA-approved silicone gel breast implant manufacturers in the USA. The Inspira product line — smooth and microtextured silicone gel in multiple cohesion levels — is the modern Natrelle offering. The 2019 worldwide recall of BIOCELL macrotextured implants substantially shifted the brand's market position; Natrelle 410 anatomical implants are no longer available. Smooth and microtextured Natrelle products continue to be widely available globally.
Company overview
| Item | Detail |
|---|
| Brand name | Natrelle (implant product line) |
| Parent company | AbbVie (acquired Allergan May 2020) |
| Original company | Allergan (founded 1948; aesthetics division historic) |
| Headquarters | Currently AbbVie HQ Chicago, USA |
| FDA approval | 2006 (silicone gel); ongoing for new variants |
| Major markets | USA, Canada, Europe, UK, Australia, Asia (variable post-2019 recall) |
The 2019 BIOCELL recall
The most significant event in modern Allergan implant history. Timeline:
- 1990s-2010s: BIOCELL macrotextured implants in widespread use.
- December 2018: France's ANSM banned macrotextured implants including Allergan BIOCELL.
- July 2019: FDA requested Allergan recall BIOCELL implants. Allergan voluntarily recalled worldwide.
- Subsequent: UK MHRA, Australia TGA, Canada Health Canada, and other regulators followed.
The recall affected hundreds of thousands of patients globally with BIOCELL macrotextured implants (Natrelle 410, BIOCELL macrotextured round). The estimated BIA-ALCL lifetime risk with BIOCELL was approximately 1 in 2,000-3,000 — substantially higher than other surface types.
Current Natrelle product lines
Inspira product family
| Product line | Surface | Gel | Notes |
|---|
| Inspira SoftTouch | Smooth | Softest cohesion | Most natural feel |
| Inspira ResponsiveSiltex | Subtle textured | Standard cohesion | Smooth-textured boundary |
| Inspira TruForm 1 | Smooth | Standard cohesion | Standard line |
| Inspira TruForm 2 | Smooth | Higher cohesion | More form-stable |
| Inspira TruForm 3 | Smooth | Higher cohesion + projection | For high-profile applications |
Discontinued / withdrawn products
- Natrelle 410 — anatomical (teardrop) implants with BIOCELL macrotextured surface. WITHDRAWN 2019.
- Natrelle BIOCELL Round — round implants with BIOCELL macrotextured surface. WITHDRAWN 2019.
- Natrelle MicroCell — finer macrotexturing. Discontinued in some markets following BIOCELL concerns.
The current Natrelle line is fundamentally a smooth-and-Siltex-microtextured product family. Patients interested in anatomical implants from FDA-approved manufacturers in USA must consider Mentor MemoryShape or Sientra; Allergan's anatomical line (Natrelle 410) was BIOCELL-textured and discontinued in 2019; Allergan currently markets smooth and microtextured Inspira products.
FDA approval status
Natrelle silicone gel implants have FDA approval for cosmetic augmentation in patients age 22 and older, and for breast reconstruction in women of any age. Specific Inspira variants have individual FDA approvals. The post-Approval Studies (PAS) tracking long-term outcomes continue. Natrelle is one of three FDA-approved silicone gel implant brands in the USA (with Mentor and Sientra).
NatrelleConfidence Plus warranty
Allergan/AbbVie offers warranty coverage for Natrelle implants:
- Lifetime replacement for confirmed rupture.
- Capsular contracture coverage — Baker grade III/IV in specific programs.
- Financial assistance for revision-related costs.
- BIA-ALCL coverage — for affected patients with covered products.
When Natrelle fits
- USA patients seeking FDA-approved silicone gel from established manufacturer.
- Patients with surgeon experienced in Inspira product line.
- Patient prioritising smooth or subtle-textured surface.
- Patient seeking softer (lower cohesion) gel feel — Inspira SoftTouch line.
When another brand may be appropriate
- Patient seeking anatomical (teardrop) implants — Mentor MemoryShape (USA) or Motiva Anatomical (international).
- Patient seeking specific technology features — Motiva for SmoothSilk, Q Inside, Ergonomix.
- Patient seeking polyurethane-coated — Polytech.
- Patient with surgeon highly experienced with another brand.
Frequently asked questions
Are Allergan implants still on the market?
Most Allergan products yes — but specifically the BIOCELL macrotextured implants were recalled worldwide in July 2019. The Inspira smooth and microtextured Natrelle product lines remain on market. Natrelle 410 anatomical implants (which used BIOCELL texture) were withdrawn. Modern Natrelle product line focuses on smooth and microtextured surfaces. Allergan brand is now part of AbbVie following the 2020 acquisition; the Natrelle implant brand continues but the company structure has changed.
What was the BIOCELL recall?
In July 2019, Allergan voluntarily recalled BIOCELL macrotextured breast implants and tissue expanders worldwide following FDA, ANSM (France), MHRA (UK), and other regulator concerns about elevated BIA-ALCL risk. BIOCELL incidence was estimated at approximately 1 in 2,000-3,000 lifetime — substantially higher than other implant surfaces. The recall removed all BIOCELL macrotextured products from the global market. Patients with existing BIOCELL implants are advised to monitor for symptoms but do not require automatic explant. See
macrotextured implants page for full recall context.
What products does Allergan/Natrelle currently make?
The current Natrelle line focuses on smooth and microtextured surfaces. Inspira product line (smooth and microtextured silicone gel in multiple cohesion levels), traditional Natrelle smooth round, and saline implants. Natrelle 410 anatomical is no longer available. Specific product variants vary by country regulatory approvals. AbbVie continues to develop and market the line.
How does AbbVie's acquisition affect Allergan implants?
In May 2020, AbbVie acquired Allergan in a $63 billion transaction. The Allergan/Natrelle implant business continues as a division within AbbVie's portfolio. Patient-facing aspects (warranty programs, product availability, regulatory status) have generally continued unchanged. Some commercial focus has shifted as AbbVie's primary business is pharmaceuticals rather than medical devices, but the Natrelle implant line remains active and supported.
Is Inspira FDA-approved?
Yes — multiple Inspira product variants have FDA approval. Inspira SmoothPlus (smooth surface, multiple cohesion levels), Inspira ResponsiveSiltex (smooth shell with subtle texturing), and Inspira TruForm (multiple firmness levels). The Inspira line is FDA-approved alongside Mentor as the FDA-approved silicone gel options in the USA. AbbVie's Inspira products represent the modern Allergan offering after the BIOCELL withdrawal.
Should I be concerned about Allergan if I have non-BIOCELL Natrelle implants?
Smooth or microtextured Natrelle/Inspira implants were not subject to the 2019 recall. The recall specifically affected BIOCELL macrotextured products. If you have smooth or microtextured Natrelle implants, no additional action beyond standard surveillance is recommended. If you are uncertain about your implant type, check operative records or consult your surgeon for confirmation. Standard MRI surveillance every 2-3 years for silent silicone rupture continues to be FDA-recommended for all silicone gel implants.
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