Recently a French manufacturer of silicone breast implants, Poly Implant Prothèse or PIP, came under Investigation by the French government for using low grade silicone in their silicone gel breast implants. The French have recommended that patients with these implants have them removed and replaced as a preventive, but not urgent matter.
These breast implants are not approved for use in the United States and I have never used them in my practice. The concern is only relevant for patients who have had breast augmentation outside the United States.
The only gel breast implants approved for use in the United States are manufactured by American companies and adhere to strict quality and manufacturing requirements.
The FDA requires extensive bio-compatibility testing on all its breast implants as described in their administration’s Summary of Safety and Effectiveness Data. These guidelines have resulted in silicone shells that have been tested and shown to possess excellent strength, resilience and elasticity.
If you have any concerns or questions about what is going on in France please do not hesitate to contact our office. If you had breast augmentation surgery outside the U.S. and would like to remove or replace your gel breast implants just please let us know.
