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Polytech implants, reBreast™
Implant Technology

Choosing a breast implant for your anatomy

Dr. Baley works with several brands and chooses the implant for each patient's case. This page describes the options he uses.

The approach

Dr. Baley has no agreement with any implant brand

The practice offers the full Polytech catalog, plus Motiva, Mentor, and Eurosilicon. The implant choice is a clinical decision made case by case, based on your anatomy, your goals, your tissue characteristics, and the latest available safety data. Dr. Baley has no brand agreement.

What follows is an overview of the technologies Dr. Baley uses most: their certifications, the clinical evidence, and why each has a place in specific cases.

On rePlantation™: The protocol uses Polytech polyurethane-coated (Microthane) implants, or B-Lite gel depending on patient profile. The choice between them is decided during your consultation.
PU · Lightweight · Germany
Polytech
CE-certified (EU MDR), ISO 13485. Microthane™ PU surface and B-Lite™ lightweight gel. Available in 60+ countries.
FDA Approved 2024 · Costa Rica
Motiva
CE mark since 2011. Available in 85+ countries.
FDA Approved · USA
Mentor
Johnson & Johnson. FDA-approved MemoryGel™ and MemoryShape™. One of the most widely used globally.
CE Mark · France
Eurosilicon
French manufacturer. CE-certified. Competitive smooth and micro-textured options for the right anatomical cases.
Polytech Health & Aesthetics · Germany · Est. 1986

Polytech Microthane™, a polyurethane-coated implant

A three-dimensional polyurethane foam surface that allows tissue to grow into the implant matrix, anchoring it and reducing rotation, with capsular contracture rates reported as lower in Polytech's registry data. CE-certified under EU MDR. Used in rePlantation™ for specific clinical indications.

Polytech's Microthane™ implants are coated with a three-dimensional open-pore polyurethane foam matrix. The coating lets tissue grow directly into the implant, anchoring it in place and reducing rotation, with lower capsular contracture rates reported in Polytech's registry data.

Polytech has operated a patient registry since 2007, one of the longest-running post-market surveillance programs in the industry.

Why France banned polyurethane implants and Australia suspended some

In 2019, France banned all macro-textured and polyurethane implants. The scientific community's response was divided.

Polytech publicly contested the ANSM ruling as not based on scientific proof. The US FDA, the UK MHRA, and most European regulators did not follow France's lead.

Australia's TGA suspended some Polytech products as part of a broader precautionary review. Most of Europe, Latin America, and Asia continue to offer Polytech PU under CE certification.

Why not FDA-approved? Polytech has not submitted a Premarket Approval (PMA) application to the FDA for the US market; the commercial pathway has not been pursued. For this reason, patients travel outside the US to get it.

Certifications

  • CE mark (EU MDR 2017/745): confirmed 2023, covering Germany, Spain, Belgium, Netherlands, and most of Europe
  • ISO 13485:2016: quality management system certification
  • Available in 60+ countries across Latin America, Asia, Middle East, and Europe
  • Not available in France (country-specific 2019 ban, still in effect)
  • Not FDA-approved for US market; FDA approval process not yet initiated
Lower
Capsular contracture rates reported in Polytech's registry data
1986
Founded. Family-owned. Dieburg, Germany.
60+
Countries where Polytech products are available

How the PU surface works

The polyurethane foam creates a microenvironment at the implant-tissue interface. Tissue grows into the open-pore matrix, effectively anchoring the implant in a way that smooth and even textured shells cannot replicate. This is why rotation is rare, and why lower rates of capsular contracture, the most common long-term complication of breast implant surgery, are reported in Polytech's registry data.

The surface is biocompatible and has been used in cardiovascular and other medical applications for decades before its use in breast implants.

Polytech B-Lite™ · Lightweight Gel Technology

Polytech B-Lite™, an implant about 30% lighter at the same volume

B-Lite gel contains hollow microspheres, first developed for aerospace use, bonded permanently inside cohesive silicone gel.

Standard silicone implants exert gravitational force on breast tissue every day, for years. This cumulative mechanical stress contributes to ptosis (sagging), tissue thinning, and long-term shape change. B-Lite reduces the weight of the implant by about 30% while maintaining equivalent volume, profile, and feel.

The hollow microspheres used in B-Lite gel are made from borosilicate glass, the same material used in medical and aerospace applications. They are permanently encapsulated within the silicone matrix and biocompatible by independent testing.

B-Lite 5-year study results

A 5-year post-market study found no new or unexpected safety signals.

Who B-Lite is best for: Patients with naturally thin or stretched tissue who want to minimize long-term gravitational effects. Patients returning for secondary surgery after previous large implants. Active patients concerned about dynamic force during exercise. Cases where volume is desired but tissue support is limited.
30%
Lighter than standard silicone implants of equivalent volume
CE
CE-certified and sold wherever Polytech is sold.
  • Aerospace-grade microspheres: borosilicate glass, permanently bonded in gel
  • Available in round and anatomical: full Polytech shape catalog
  • Compatible with Microthane surface: B-Lite Microthane version available
  • Same incisions, same technique: no procedural changes from standard implants
Other options available

Other implants Dr. Baley uses

For patients who specifically want an FDA-approved implant, or whose anatomy calls for a different approach, the following options are all available. The full consultation determines which is right.

01
Motiva
Establishment Labs · Costa Rica · FDA Approved 2024

Approved by the FDA in 2024. Available in 85+ countries. CE-marked since 2011. SmoothSilk™ surface and Ergonomix™ ergonomic shape range: implants that respond to body position the way natural tissue does.

FDA PMA CE Mark ISO 13485 85+ Countries
02
Mentor
Johnson & Johnson · USA · FDA Approved

One of the two longest-established FDA-approved implant brands in the United States. MemoryGel™ cohesive silicone gel and MemoryShape™ anatomical range. Decades of post-market safety data. A conservative, well-documented choice for patients who want the longest FDA track record. Smooth and moderately textured surface options available.

FDA PMA CE Mark ISO 13485 Global Markets
03
Eurosilicon
Eurosilicon · France · CE Certified

A CE-certified European manufacturer offering smooth and micro-textured silicone gel implants. It suits patients who want a well-tested implant at a lower price than the larger brands. Round and anatomical profiles available. Solid clinical track record across European and Latin American markets. Available in all relevant anatomical sizes and projections.

CE Mark ISO 13485 Europe · LatAm
What FDA approval means: FDA approval means a product has met the FDA's clinical evidence standards for the US market. Motiva was available internationally for over a decade before US approval. Dr. Baley chooses the implant that fits your anatomy and goals, whichever agency approved it.
Choose with full information

Talk with Dr. Baley about which implant fits you

Dr. Baley reviews your anatomy, your history, and your goals, then recommends the implant that fits your case.

JCI
Centro Médico ABC
CMCPER