German manufacturer infringes patent of Brazilian polyurethane breast implant technology - court grants Silimed preliminary injunction

• Preliminary injunction orders German company to cease manufacture, marketing, sales and distribution in Germany of infringing products or risk up to a 250,000 Euro fine for each breach.
• Court ruling follows a near decade long litigation over polyurethane-coated implant manufacturing technology.
• Brazilian company Silimed is currently the sole manufacturer globally of implants made with this clinically established patented technology, which lead to less complications in breast cancer patients who have reconstructive surgery.

A long-running legal dispute to determine patent ownership of one of the world's most effective and respected breast augmentation and reconstruction technologies has resulted in a German court issuing a preliminary injunction finding patent infringement by a German manufacturer.

MUNICH, April 24, 2026 /PRNewswire/ -- The Regional Court of Munich granted Silimed® Indústria de Implantes Ltda (Silimed) a preliminary injunction against Polytech Health and Aesthetics GmbH (Polytech), served on the German company in recent days, ordering it to immediately stop manufacturing, distributing, and marketing polyurethane (PU) silicone breast implants in Germany using Silimed® patented technology according to European Patent EP 2 582 193 B1.  Failure to comply will result in up to a 250,000 Euro for each breach by Polytech or up to six months of imprisonment, or up to two years for a repeat offense.  Under this preliminary ruling Polytech also cannot resupply distributors outside of Germany.

Silimed® and Polytech were the only two manufacturers of PU coated breast implants according to the patented method, which produced a product favoured by many surgeons globally.

In December 2024, the Frankfurt Higher Regional Court awarded Silimed the patent. Polytech appealed, but the German Federal Court of Justice dismissed the appeal shortly before Christmas 2025, and Silimed is now enforcing its patent rights.

This means that Silimed® is currently the only manufacturer of this important patented technology globally to meet the needs of a 600–900-million-euro market and approximately 250,000 patients a year. To maintain stability of supply, Silimed® is expanding its manufacturing and distribution to meet additional demand from surgeons and patients.

Responding to the preliminary injunction, Gabriel Robert, CEO of Silimed® said: "The Regional Court Munich's decision is a relief and a vindication for the decades of dedication and labour behind our own polyurethane foam-coated implant technology, beginning with my family in the 1980s. Personally, it brings me great pride to have fought for the 'Made in Brazil' technology which today helps to ensure safe and effective breast augmentation and reconstruction surgeries for approximately 8–10% of implant procedures, representing over 250,000 of patients in Europe and South America annually.

Silimed® has been servicing discerning surgeons who choose these implants for decades, and we are ready and able to increase our production to fully satisfy the market demand in response to this ruling. We look forward to working with our established and new partner surgeons to ensure uninterrupted access for all patients to this vital technology."

Brazil is known as a global leader in breast augmentation and reconstruction procedures, where 11.8% of all breast augmentations globally are performed[1] and technology is among the most advanced in the world. Under the Court's judgment, which is not yet final, the preliminary injunction against Polytech is effective immediately. Polytech has filed an appeal against the first-instance judgement with the Munich Court of Appeals; the appeal is currently pending.

About Silimed®

Founded in Brazil in 1978, Silimed® is a global manufacturer of silicone breast implants for aesthetic and reconstructive surgery, with a longstanding role in the development of plastic surgery and a presence in over 45 countries. Silimed® offers one of the most comprehensive portfolios in the market, including multiple surface technologies, shapes, and projection options to support individualized surgical planning. Developed in continuous exchange with plastic surgeons, Silimed® integrates clinical insight into its product evolution, reflecting its commitment to connecting science with wellbeing.

All implants are manufactured under strict quality standards and comply with applicable international regulations, including European certification (CE). Silimed® continues to evolve its portfolio in line with the needs of surgeons and patients.

About polyurethane foam-coated implants

Pure Polyurethane® implants are part of Silimed®'s long-standing commitment to purposeful design, combining decades of engineering expertise with continuous clinical collaboration. Since the beginning of production in 1989, this surface has evolved through key milestones, including advancements in surgical techniques to support tissue integration and expanded profile options to address diverse anatomical needs. Manufactured through a proprietary, European-patented process this technology is designed to promote adherence to surrounding tissue, supporting positional stability over time. This interaction has been associated in clinical experience with low rates of malposition and capsular contracture, while contributing to the consistency of shape and projection. Supported by global standards and extensive clinical experience, Silimed®'s polyurethane implants reflect a legacy of innovation rooted in Brazil and trusted worldwide.

[1] International Society of Plastic Surgery: International Survey on Aesthetics/Cosmetic Procedures Performed in 2024

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