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Breast18 February 20214 min read

The best-known breast implant manufacturers compared

Besides the surgeons, the breast implants used also play a decisive part in the result of aesthetic breast augmentations or reconstructions, and unfortunately some of them have attracted negative press in recent years. Below you can find out more about the most common breast implant manufacturers.

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The key points in brief

  • Recalls and warningsWith Allergan, pfm, Silimed and PIP there were recalls, industrial silicone or suspended certificates.

  • Our manufacturersAt Westfalenklinik we use implants from Polytech, Motiva and Mentor.

  • ConsultationWe discuss which implant is an option for you and what risks are associated with it in the consultation.

Manufacturers with recalls or warnings Manufacturers whose implants we use
Allergan Mentor
Poly Implant Prothèse (PIP) Motiva
Silimed Polytech Health & Aesthetics
pfm medical titanium GmbH

Other manufacturers: GC Aesthetics (Eurosilicone, Nagor).

Manufacturers with recalls or warnings

In recent years there have been recalls, approval problems or warnings from the authorities concerning breast implants from the following manufacturers:

Allergan – recall of the Biocell implants

The well-known American breast implant manufacturer Allergan had high quality standards for its more than 500 different breast implant variants. In an FDA study in 2018, however, the implants of the Biocell range performed poorly and were suspected of promoting cancer. The company then stopped production, recalled the implants and has since been taken over by the research-based biopharmaceutical company AbbVie.

pfm medical titanium GmbH – problems from 2012

Alongside Polytech Health & Aesthetics, pfm medical titanium GmbH is one of the well-known German implant manufacturers. Pfm in Nuremberg specialises in titanised mesh implants, which are used not only in breast surgery but also in urology or gynaecology. All are important for reconstructive surgery. In 2012, pfm was involved in the PIP scandal because the company had sourced the TiBREEZE implants from PIP, which contained the dangerous industrial silicone.

Silimed – CE certificate suspended in 2015

The Brazilian company sells its products worldwide through various partners such as Triconmed or Polytech. Because a TÜV inspection of the production site revealed surface contamination of the product, it did not receive a CE certificate for its medical devices in 2015. As a result, not only the implants but also other products were affected.

Poly Implant Prothèse (PIP) – serious defects

The implants of the French company Poly Implant Prothèse (PIP) caused a great media stir in 2012 that continues to this day. Industrial silicone was found in the implants, which also turned up at the manufacturers Rofil and GfE Medizintechnik GmbH. The implants were therefore taken off the market.

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Other manufacturers

Eurosilicone

The French breast implant manufacturer is one of the large producers in this segment. It makes over 250,000 implants a year, which are supplied to over 90 countries. The range of CE- and ISO-certified implants includes an extensive assortment of breast implants in different shapes, sizes and profiles. In 2019, however, some breast implants from Eurosilicone and five other manufacturers were banned in France on suspicion of causing cancer. Since then, the company has launched a product and quality offensive. According to the manufacturer, every Eurosilicone implant comes with a lifetime product replacement guarantee.

Nagor

Nagor has been established on the market for more than 33 years and sells its products worldwide. It is the only manufacturer in England and Scotland and, together with the company Eurosilicone, belongs to the GC Aesthetics Group. According to the French health authority ANSM, some implants offered in the past are suspected of causing cancer and were withdrawn from circulation. In 2019, according to the Ärzteblatt, five other manufacturers were also affected: Allergan, Arion, Sebbin, Eurosilicone and Polytech. The company intends to counter this experience: since then it has focused specifically on quality and wants to demonstrate this with scientific expertise in studies.

Manufacturers whose implants we use

The products of the manufacturers presented below are used by many doctors and, for good reasons, are also used in our clinic. According to the manufacturers, they are intended to reduce the risk of capsular fibrosis and are protected against leaking.

Mentor

The American company has belonged to the Johnson & Johnson group since 2009 and makes silicone gel implants as well as implants filled with saline solution. In 2006, the breast implant manufacturer Mentor was the only company apart from its competitor Allergan to receive FDA approval. The approval criteria of the American authority for food and drug law (FDA) are considered particularly strict. In Europe, the approval procedure does not provide for testing of the products but merely for testing of the manufacturing process, for example by TÜV.

Motiva

Motiva implants are made by the company Establishment Labs, which, according to its own information, can look back on 30 years of experience with breast implants. Modern gel structures are intended to allow a natural feel; the nanotechnologically optimised surface and the Blueseal protective barrier are intended to make the implant better tolerated and protect it against leaking.

Motiva implants can contain an RFID chip on which a serial number is stored. The 15-digit number helps the patient if in doubt: a doctor can easily read out important information about the implant even without an implant passport. Motiva implants do not yet have FDA approval (as at the time of this article: 2021), but are CE-tested.

Polytech Health & Aesthetics

The company from Dieburg has been on the market since 1986 and supplies a wide range of products for aesthetic-plastic as well as reconstructive surgery. For its silicone breast implants, the breast implant manufacturer Polytech uses a patented surface made of Microthane, which is intended to reduce the risk of so-called capsular contracture. The breast implant manufacturer Motiva follows a similar approach with a special nano-texturing that is intended to make the implants better tolerated. According to the company, Polytech's breast implant shells are intended to prevent leaking and to be well tolerated. The surfaces used were tested by the Staatliche Materialprüfungsanstalt Darmstadt and comply with EN ISO 14607:2018.

Conclusion: Which implants do we use?

We use only tested products from the companies Polytech, Motiva and Mentor, which we regard as a well-tolerated choice for our patients. For all three brands we can offer many different profiles and shapes so that the implant suits your starting situation. We discuss with you in the consultation which implant is an option for you and what risks are associated with breast implants.

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