January 20th, 2012 Miguel A. Delgado Jr, MD
There have been a lot of reports in the news lately about a French manufacturer of defective breast implants used for breast augmentation surgery. It was discovered that Poly Implant Prothese (PIP) a now defunct company had been using industrial grade silicone instead of the more expensive medical grade for their silicone implants. According to Wikipedia, industrial grade is only 10% of the cost of medical grade.
In 1996, PIP was selling their saline implants in the United States including the San Francisco Bay Area, but saline and silicone implants were distributed to many countries worldwide. All silicone implants were banned in the United States from 1992-2006 due to health concerns but reintroduced after extensive testing proved them to be safe. Only two breast implant companies are approved by the FDA, Mentor and Allergan.
PIP became the third largest breast implant company in the world before being shut down in 2010 when the discovery was made. A Dutch company rebranded the implants with the name Rofil M-implants, and is also at risk as the contents are the same. In 2000 the FDA sent an inspector to the PIP manufacturing company and found many substandard practices thereby banning all PIP implants for the United States.
The American Society for Aesthetic Plastic Surgery (ASAPS) recommends women have the implants removed due to the high rupture rate and also due to the fact that the adverse effects of the impurities used in industrial grade silicone are unknown. The International Society of Aesthetic Plastic Surgery (ISAPS) supports this recommendation. Different countries have different recommendations. Several countries recommending removal besides the United States are; France, Germany, Venezuela and the Czech Republic. Some countries are setting up registries and hotlines but not recommending removal at this time.
Dr. Delgado recommends that women who have had breast augmentation surgery outside of the United States to get in touch with their surgeon to verify what type of implants they have. Dr. Delgado also stresses the importance of all women to know the brand, size of their implants and if they are saline or silicone.
For a limited time, Dr. Delgado is offering a reduction in surgical fees to San Francisco Bay Area women who wish to have their PIP implants removed. For more information please contact the office.