The market for breast prosthesis
What brands of breast prosthesis exist today worldwide?
USA: Mentor (Johnson & Johnson), Perthese (Johnson & Johnson), Natrelle (Allergan)
Germany: Polytech
France: Eurosilicone, Cereplas, Sebbin
United Kingdom: Nagor
Brazil: Silimed
What kind of security do they offer?
All breast prosthesis for medical use are required to submit to a physical safety test list as well as toxicity, mutagenicity and microbiological tests. The parameters are similar throughout the world, although the European CE marking is common for all brands, only Mentor and Allergan have approved the US FDA marking whose level of demand is higher.
How are they different one from another?
There are no great differences at first sight, but they are evident in the manufacturing process, in the choice of materials, sealing of the valves, number of layers of silicone in their wrapping, degree of cohesiveness of their gels, safety controls, etc. . Not all implants offer the same guarantees.
FDA approval initially only included saline implants and since 2006 has been extended to 5 types of silicone gel between Mentor and Allergan. The rest of the brands fight for the entrance.
What warnings should be taken into account with the use of breast prosthesis?
Implants are not for life. Their materials may become fatigued, ruptured or deteriorated and may require replacement with secondary surgeries.
Patients should have information about the implants that the physician is able to provide: fabrication, safety testing, warranties, alternatives, major implant complications, batches, health records, models.
They should be aware of the possible long-term risks: although the relationship between implant use and cancer, conjunctive or reproductive diseases has not been demonstrated, longer-term studies would be necessary to completely rule out these complications.
Controls of implanted prosthesis are crucial until their replacement or definitive removal. The ultrasound control provides all the necessary information to maintain the tranquility of the patient regarding the good condition of the implant.
Dr. José Salvador
Plastic surgery, aesthetic medicine, antiaging and nutrition
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