Implant Surface · 3 of 4
Macrotextured surface implants
Coarse-pore surface texture — dominant for anatomical implants 2000-2018, largely withdrawn after 2019 Allergan BIOCELL recall due to elevated BIA-ALCL risk. Modern reference for patients with existing BIOCELL implants.
Clinical summary
Macrotextured implants — particularly Allergan BIOCELL pattern — were the dominant texture for anatomical implants from 2000-2018. The 2019 worldwide recall of BIOCELL macrotextured implants by Allergan, following BIA-ALCL incidence data showing approximately 1 in 2,000-3,000 lifetime risk, fundamentally reshaped the implant surface landscape. Modern practice uses microtextured for anatomical and smooth for round; macrotextured is largely withdrawn. Patients with existing BIOCELL implants do not require automatic explant but should monitor for symptoms.
The four surface categories
| Surface | Texture scale | BIA-ALCL risk profile | Best for |
|---|
| Smooth | Polished/glossy | Essentially undetectable | Round implants where rotation doesn't matter |
| Microtextured | Fine surface roughness (~50-100 µm) | Lower than macrotextured | Anatomical implants; modern standard |
| Macrotextured | Coarser pores (~200-700 µm) | Higher (BIOCELL-pattern recalled 2019) | Largely withdrawn from market |
| Polyurethane-coated | Foam-like coating | Very low | Specialty — strong tissue adherence, low rotation |
The surface decision is one of the most clinically meaningful in implant selection. Surface affects rotation risk (anatomical implants need texture; round don't), capsular contracture rates (debated but historically textured had lower rates), and BIA-ALCL risk (specifically associated with macrotextured surfaces).
What macrotextured was
Macrotextured surfaces had pore sizes of approximately 200-700 microns — visible as deliberate textured surface, often described as "salt-and-pepper" or "rough." Major macrotextured products historically:
- Allergan BIOCELL — dominant macrotextured surface; foam-based negative imprinting. Recalled 2019.
- Mentor Siltex — actually microtextured (smaller pores than BIOCELL); not subject to recall.
- Sientra TRUE Texture — variant macrotextured; subsequently transitioned.
The 2019 BIOCELL recall
Timeline of events leading to the recall:
- 1990s-2010s: macrotextured implants in widespread use; some BIA-ALCL cases reported but considered rare.
- 2018: France's ANSM banned macrotextured implants (specifically Allergan BIOCELL).
- July 2019: FDA requested Allergan recall BIOCELL implants. Allergan voluntarily recalled worldwide.
- Subsequent: other regulators (UK MHRA, Australia TGA, Canada Health Canada, etc.) followed with similar actions.
The recall affected hundreds of thousands of patients globally. The FDA estimated BIA-ALCL lifetime risk with BIOCELL implants at approximately 1 in 2,000-3,000 (some studies suggest higher in specific populations). For comparison: smooth implants have essentially undetectable BIA-ALCL risk; microtextured implants approximately 1 in 30,000-100,000.
BIA-ALCL understanding
BIA-ALCL (breast implant-associated anaplastic large cell lymphoma) is a rare cancer of the immune system that develops in the capsule (scar tissue) around a breast implant. Key facts:
- Specifically associated with macrotextured surfaces — not silicone gel filler itself.
- Average time to diagnosis after implantation: 8-10 years.
- Symptoms: new fluid collection (seroma) around implant, breast swelling, palpable mass, asymmetry developing 1+ years post-op.
- Highly treatable when diagnosed early — typically curative with capsulectomy and implant removal.
- Approximately 1,000+ cases reported globally as of 2024.
See dedicated BIA-ALCL page for current evidence overview, symptoms, and management.
What patients with BIOCELL implants should do
| Action | Recommendation |
|---|
| Automatic explant | NOT recommended for asymptomatic patients |
| Confirm your implant type | Yes — check operative records or consult surgeon |
| Monitor for symptoms | Yes — new asymmetry, swelling, palpable masses, fluid collection |
| Routine MRI surveillance | Yes — for silent silicone gel rupture, every 2-3 years |
| Imaging if symptoms develop | Yes — ultrasound or MRI immediately |
| Consult surgeon if concerns | Yes — early evaluation reassures and identifies issues early |
| Elective explant for anxiety | Discuss with surgeon — patient choice supported |
Modern replacement options
For patients undergoing implant exchange (whether for BIOCELL concern or other reasons), modern replacement surfaces:
- Smooth surface round — most common modern choice for round implants.
- Microtextured anatomical — modern choice when anatomical shape is required.
- Polyurethane-coated — specialty option for complex revision (Polytech).
The shift in modern practice toward smooth and microtextured surfaces reflects the post-2019 risk-benefit reassessment. Modern implant exchange is a well-established procedure — see implant exchange page for details.
Frequently asked questions
Why were Allergan BIOCELL macrotextured implants recalled?
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 (breast implant-associated anaplastic large cell lymphoma) risk. BIA-ALCL incidence with BIOCELL macrotextured implants was estimated at approximately 1 in 2,000-3,000 lifetime — substantially higher than other implant surfaces. The recall removed BIOCELL macrotextured implants from the global market. Patients with these implants do not require automatic explant but are advised to monitor for symptoms and consult their surgeon.
Are any macrotextured implants still available?
Some non-BIOCELL macrotextured surfaces remain available in specific markets, but the category has substantially contracted since 2019. Polytech polyurethane-coated implants (sometimes categorised as a separate macrotextured-related category) remain widely available in Europe. Some other macrotextured variants (Mentor Siltex was already in the lower-risk microtextured category) continue but with restricted use. The 2019 recall fundamentally shifted the market toward microtextured and smooth surfaces.
What should I do if I have BIOCELL macrotextured implants?
FDA, ANSM, MHRA, and other regulators do not recommend automatic explant for asymptomatic patients with BIOCELL implants. Recommended actions: (1) confirm your implant brand and texture by consulting your operative records or your surgeon; (2) monitor for new breast asymmetry, swelling, palpable masses, or fluid collection; (3) consult your surgeon if any concerning symptoms develop; (4) understand that BIA-ALCL is treatable when diagnosed early — typically curative with capsulectomy and implant removal. Patients with concerning symptoms or anxiety can discuss explant with their surgeon.
Can I have BIA-ALCL with non-Allergan macrotextured implants?
BIA-ALCL has been reported with multiple macrotextured implant brands (Allergan BIOCELL had highest documented incidence; other macrotextured surfaces had lower but not zero risk). The 2019 recall focused on BIOCELL specifically, but the broader category of macrotextured surfaces is associated with elevated BIA-ALCL risk compared to smooth or microtextured. Patients with any macrotextured implant should monitor for symptoms similarly.
Why was macrotexturing thought to be beneficial historically?
Macrotextured surfaces were developed in the 1990s-2000s with two primary goals: (1) lower capsular contracture rates by allowing tissue ingrowth into the larger pores, and (2) anchor anatomical implants in correct orientation through tissue adherence. These benefits were real — macrotextured implants did show lower contracture rates than smooth in clinical studies, and provided rotation immunity for anatomical shapes. The benefits were substantial enough that macrotextured was the dominant surface for anatomical implants from approximately 2000-2018. The unforeseen BIA-ALCL risk emerged in long-term follow-up.
Will my replacement implants need to be macrotextured?
No — replacement implants from any patient with explanted macrotextured implants would be smooth or microtextured in modern practice. The 2019 recall and subsequent shift have made macrotextured replacement uncommon. Modern surgeons select smooth round (most common) or microtextured anatomical (when anatomical shape is required) for replacement. For specific cases requiring polyurethane-coated implants (some revision indications), Polytech polyurethane-coated remains available in European markets.
Related references