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Patients with PIP Breast Implants
by Dr. Max Polo
In December of 2011 during a French governmental inspection of silicone gel breast implants manufactured by the company Poly Implant Prothese (PIP), health authorities discovered that the implants did not meet legal requirements or industry standards. Most were filled with industrial grade silicone that does not meet the same stringent quality requirements as medical grade silicone. Of additional concern was that the rupture rate of these implants had been found to be nearly five times higher as compared to other implants. Some PIP implants may also have been rebranded as "M" implants and distributed by the company ROFIL Medro in the Netherlands. Governments and plastic surgery societies around the world have since recommended that any patients with PIP implants or M-Implants by ROFIL Medro, even without any clinical signs of rupture, should have the implants removed or exchanged immediately to avoid potential health risks.
All PIP breast implants were produced in France. Since 2001, more than 300,000 were sold in over 65 countries. An estimated 30,000 French women were implanted with these implants and another 40,000 women in the U.K. More than half of those produced were exported to countries in South America including Brazil, Argentina, Chile, Colombia and Venezuela. PIP silicone gel-filled implants were never approved for use in the United States. In 2000 the company applied for FDA approval for U.S. sales. The application was rejected due to failure of PIP to investigate problems with deflation and to report hundreds of complaints. After their inspection, the FDA actually posted a letter on the internet warning that some products produced by PIP were found to be "adulterated", and ordered all devices manufactured by PIP to be detained upon entry to the U.S.
The founder of Poly Implant Prothese has recently been arrested and is facing criminal charges for alleged fraud involving intentional violation of safety rules and deception of safety inspectors. Although no women were implanted with PIP implants in the U.S., there certainly are numerous victims of this unscrupulous activity now residing in South Florida. Anyone who is concerned that they may have PIP implants should first review their medical records. For those who may not be able to return to their original surgeon, Max Polo, M.D. will provide a private consultation free of charge. Dr. Polo will perform a detailed physical examination and will provide recommendations regarding all available options for implant removal or exchange and any other indicated procedures. Women with breast implants not manufactured by PIP or ROFIL Medro are not affected and should feel safe.
Dr. Max Polo is certified by the American Board of Plastic Surgery and is a member of the American Society of Plastic Surgeons. He has been in private practice in the Miami area for more than 10 years. During that time a majority of his practice has been dedicated to breast aesthetics and breast health in women and in men. Dr. Polo has performed thousands of breast surgical procedures, including primary and revision augmentations, lifts, reductions, gynecomastia excisions and reconstructions for cancer. Among these procedures, several hundred have involved breast implant exchanges. Dr. Polo uses only FDA approved breast implants manufactured by Mentor and Allergan, the two U.S. based manufacturers. Throughout his career Dr. Polo has served as a voluntarily consultant to these companies in working toward furthering the safety and efficacy of their implants and of other devices and products utilized for aesthetic and reconstructive breast surgery. During the 14 year hiatus when silicone gel implants were banned from use in the U.S and since, Dr. Polo has contributed as an investigator in the clinical trials that led to their re-approval in 2006. With this extensive experience, Dr. Polo can offer the highest level of care to patients in need of having their PIP implants removed or exchanged.