FDA Banned and Subsequently Allowed Silicone Implants
Why did the FDA ban silicone implants in the first place?
The ban occurred for a number of reasons:
Ø Pressure from the media, trial lawyers, and various activist groups was intense after the Connie Chung show in 1990.
Ø There was fear that they were not safe.
Ø They were never approved by the FDA to begin with. They were “grandfathered in 1976 when the FDA began the process of approval as a formal process.
Even though there was a large amount of research including animal data and human data on the safety of these devices, the FDA elected to take implants off the market entirely at first and then allowed their use in reconstruction only. As of November 17, 2006 the FDA lifted the ban on the use of silicone implants for breast augmentation surgery. This was because 14 years of research in the U.S. and abroad found no connection between silicone implants and all the diseases claimed by women to be associated with their silicone implants. That means that women desiring breast augmentation surgery have the option of choosing a silicone gel filled implant for her augmentation. This choice will have a number of requirements imposed by the FDA. The FDA is requiring, or at least strongly suggesting, MRI examinations after the first three years and every two years following that. Also the patient must be a minimum of 22 years of age (18 years of age minimum for saline implants).
For more information, check out the FDA website: www.fda.gov/cdrh/breastimplants. This website has a wealth of information regarding breast implants and is helpful to women trying to make a rational choice regarding breast augmentation surgery. It also spells out the long term follow up of silicone gel filled implants.