You may have heard recent news highlighting safety issues and a recall of breast implants made by a French manufacturer, Poly Implant Prothese (PIP). CNN recently reported:
French authorities announced last month that the government would pay for the removal of the bankrupt company's implants, which a British medical group says were made from nonmedical grade silicone believed by the manufacturers to be made for mattresses.
The World Health Organization (WHO) placed a ban on PIP implants in 2010, when authorities in Europe learned that PIP was using substandard silicone gel in the manufacturing of the PIP implants. In fact, the WHO completely withdrew PIP silicone breast implants from the entire European Union (EU), as well as other non-EU countries. This withdrawal included a suspension of all marketing, distribution and export of PIP implants. PIP went bankrupt shortly after the ban. Hundreds of thousands of women in Europe, South Africa, Latin America, and elsewhere have received PIP implants. Needless to say, those who have PIP implants are concerned.
The French Regulatory Authority (AFSSAPS) has determined, through regulatory testing, that PIP implants have a higher than expected rate of rupture and leakage. In fact, AFSSAPS found that the non-approved silicone gel contributed to tissue irritation and, when leaking, an increase in inflammation and pain. The AFSSAPS has recommended that women with PIP implants have them removed as a preventive measure.
PIP implants were sold in the United States until the year 2000. If you think you might have PIP implants, please click here for more information from the WHO.
Rest assured, however, there is good news if you're considering a breast augmentation! Maryland-located Bella Cosmetic Surgery uses implants that are made in the U.S. with medical grade silicone. Further, they are made according to strict quality manufacturing requirements, and are subject to strong regulatory testing. Our manufacturer follows FDA guidelines for bio-compatibility testing, for additional safety.
At Bella Cosmetic Surgery, there is no exception to high standards and quality products for our procedures, including breast augmentation. Maryland residents know that it’s important to Dr. Chiaramonte, and the entire Bella Cosmetic Surgery staff, that otheir health comes first. If you have any questions or concerns, please feel free to call our office at (301) 567-6767.