Silimed Quality Statement Regarding PIP Breast Implant Recall

December 21, 2012: Authored by: Alpha Health Asia Staff

There are patients seeking breast augmentation that have questions about the safety of breast implants following the recall of breast implants manufactured by PIP, Silimed released a quality statement regarding the Silimed breast implants and PIP, the statement can be found below.

Alpha Health Asia has full registration and approval of Silimed implants in Singapore, Thailand, Malaysia and Vietnam, we have worked extensively with leading doctors, hospitals and regulatory agencies in these countries for years, we have never experienced any product recall, regulatory issue or significant patient complication.

Silimed breast implants are FDA approved, they are safe and Alpha Health Asia has years experience working with thousands of patients seeking breast augmentation in the ASEAN region without quality issues. There are many brands of breast implants, please make sure you select a high quality brand that is FDA approved in order to avoid issues like those surrounding the PIP implants.

The Quality Statement from Silimed:

Rio de Janeiro, January 04th, 2012


With respect to the customers and to the plastic surgeons that use Silimed's mammary implants, we want to address any possible doubts that can be raised as a consequence of the news on the implants of the French company Poly Implant Prosthesis (PIP).

After 33 years in the market, today Silimed is the largest manufacturer of silicone implants in Latin America and the third largest in the world. The company exports to more than 60 countries, with the commitment of supplying safe and quality products.

Thru this time, Silimed developed a rigorous production process, investing in research and technology to assure that its products comply with all safety and quality standards determined by health authorities of the countries in which we sell.

Therefore, Silimed products are registered with the organizations such as ANVISA (National Agency of Sanitary Surveillance) in Brazil and the FDA (Food and Drugs Administration), in the United States, besides bearing the CE mark, the certificate of conformity of the European Union.

The whole production process is monitored thoroughly and the implants are made in approved environmental conditions determined by Good Manufacturing Practices (GMP) of ANVISA, the FDA and certified by the norms ISO 9001 and ISO 13485. Periodically external auditing is done by international organizations to confirm our Quality System.

Silimed uses only high quality raw materials, with advanced technology. The silicone used in the production is imported from United States (Applied Silicone Corporation) and is 100% of medical grade, and is regulated by the FDA.

Silimed - Quality Assurance

With so many years invested in quality and safety, Silimed developed a system to guarantee the origin of their implants and, therefore, their safety and conformity with quality requirements. Silimed was the first company to print serial numbers in each implant manufactured, thus guaranteeing 100% of safety in the traceability of the implant.

When acquiring a Silimed implant, patients receive a card containing information with the reference and serial number of the implant, the date of surgery, and the doctor's name. This confirms the quality of the implant for the patient.

Kind Regards,

SILIMED – Indústria de Implantes Ltda.

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