Allergan Natrelle Breast Implants: Product Lines, Safety & Warranty: Learn about Allergan Natrelle breast implants, Inspira options, BIOCELL recall history, warranty coverage, safety data, and brand comparisons.
Key Takeaways
- Allergan (now part of AbbVie) is the largest breast implant manufacturer in the US market, offering the Natrelle brand.
- The Natrelle Inspira line includes round silicone gel implants in multiple cohesivity levels (SoftTouch, Responsive, Cohesive) and five profiles.
- In July 2019, Allergan voluntarily recalled all BIOCELL textured breast implants worldwide due to BIA-ALCL association.
- All currently available Natrelle implants are smooth-surfaced following the BIOCELL recall.
- The Natrelle 360+ Program and ConfidencePlus warranty provide financial protection for qualifying complications.
- Allergan's Core Study and TOPS study provide the most comprehensive long-term safety data of any manufacturer.
Company Overview
Allergan (acquired by AbbVie in 2020) has been a leading manufacturer of breast implants for decades. Their Natrelle brand represents one of the most widely implanted breast implant product lines worldwide.
Allergan was the first to receive FDA approval for silicone gel breast implants when the market reopened in 2006, following the 14-year moratorium.
Product Lines
The current Natrelle portfolio includes:
Natrelle Inspira (Silicone Gel)
The Inspira line is Allergan's flagship silicone gel series, available in three gel cohesivity levels and five profiles:
- SoftTouch (SCF): Lowest cohesivity — softest feel, most natural movement. Best for patients prioritizing a natural breast-like feel.
- Responsive (SRF): Medium cohesivity — balances softness with shape retention. The most versatile option.
- Cohesive (SCX): Highest cohesivity — firmest gel, best shape stability. Closest to "gummy bear implants" in the Natrelle line.
Profile Options
- Low Profile: Widest base, least projection — for broad-chested patients wanting subtle augmentation.
- Moderate Profile: Balanced width-to-projection ratio.
- Full (Moderate Plus) Profile: Slightly narrower base with more forward projection.
- High Profile: Narrow base with maximum forward projection — for petite frames or patients wanting more projection.
- Extra-Full Profile: Maximum projection with the narrowest base — for significant projection goals.
Natrelle Saline
Allergan also offers saline breast implants, available in smooth round configurations with moderate and high profiles. Saline implants are FDA-approved for patients 18 and older.
The BIOCELL Recall (2019)
In July 2019, Allergan voluntarily recalled all BIOCELL textured breast implants and tissue expanders worldwide at the FDA's request. BIOCELL textured products were associated with the majority of confirmed BIA-ALCL cases globally.
- The recall applies to all BIOCELL textured implants and tissue expanders — not smooth Natrelle products.
- Approximately 573,000+ BIOCELL devices were distributed in the US before the recall.
- Allergan provides support programs for affected patients requiring implant exchange.
- All Natrelle implants currently sold are smooth-surfaced.
If you currently have BIOCELL textured implants, the FDA and Allergan recommend continued routine monitoring but NOT preemptive removal unless you develop symptoms (primarily late-onset swelling). Discuss your individual situation with your plastic surgeon.
Warranty & Support Programs
Allergan offers comprehensive warranty coverage:
ConfidencePlus Warranty
- Lifetime replacement: Free replacement implant for rupture at any time.
- Financial assistance (first 10 years): Up to $3,500 in financial assistance for covered complications within the first 10 years.
- Capsular contracture coverage: Baker Grade III/IV capsular contracture within 10 years.
- Registration required: Must be enrolled within 90 days of surgery.
Natrelle 360+ Program
An enhanced program offering additional benefits beyond the base warranty, including extended financial support, educational resources, and priority customer service. Details and availability may vary by region.
Clinical Safety Data
Allergan has the most extensive long-term clinical data of any breast implant manufacturer:
Major Allergan/Natrelle clinical studies and key outcomes.
| Study | Duration | Key Findings |
|---|---|---|
| Core Study | 10 years | Capsular contracture rate: 8.8% (augmentation); Reoperation rate: 24.2% |
| TOPS Study | 10 years | Inspira-specific data; generally lower complication rates than earlier generations |
| Post-Approval (PAS) | Ongoing | FDA-required long-term surveillance data |
How Allergan Compares
In the competitive landscape:
- vs. Mentor: Comparable quality — Allergan offers more cohesivity options (three vs. two) and more profiles. Mentor has a slightly different gel feel.
- vs. Sientra: Allergan has broader market access (not restricted to board-certified plastic surgeons). Sientra positions itself as a premium niche brand.
- vs. Motiva: Allergan has more long-term US data. Motiva is newer with innovative surface technology but less track record in the US market.
- Market position: Largest US market share, most widely available, most extensively studied.
Frequently Asked Questions
References & Sources
- Natrelle Breast Implants Important Safety Information. Allergan Product Information (2025) . View source ↗
- FDA requests Allergan voluntarily recall Natrelle BIOCELL textured breast implants. FDA Safety Communication (2019) . View source ↗
- 10-year results from the Natrelle 410 anatomical form-stable silicone breast implant core study. Aesthet Surg J (2015) . View source ↗
This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always consult with a board-certified plastic surgeon or qualified healthcare provider before making any medical decisions.