[Breast implants in France. New regulations, and qualitative and quantitative study of breast implants sold between...

Breast implant surgery is now regulated by health laws, which stopped concerns and debates about the safety of the implants in the 90'. After a 6 years ban, silicone gel-filled implants have been allowed by the Afssaps (a national health agency) in 2001, for use in France. The comeback of the silicone gel implants has been a breakthrough in the breast implant market.

Our goal was to assess breast implant use in France, from 1995 til 2004, a time of deep turmoil for breast implant surgery due to new regulations.

All manufacturers have been requested to participate in the study and send their confidential data regarding the number and type of implants sold yearly, from 1995 to 2004.

Breast implant sales rose by 53% in 2001, and increase by +383% from 1995 to 2004. The total number of breast implants sold in 2004 reached about 61 800. Following the lift on their ban, silicon gel-filled implants became immediately first-choice implants (they represented 72% in 2001 and more than 97% of all implants sold in 2004); saline filled implants are now rarely used. Textured envelopes are more often used (they represented 73 to 97% between 1995 and 2004), and smooth envelopes represented about 15%.

Health agencies in France and Europe would benefit from a better knowledge of the use and follow-up of breast implants. These are plastic surgeon' or scientific society' responsibilities. A national breast implant registry may be a useful tool to gather information, to improve long-term follow-up and to provide better care to women concerned themselves with breast implant surgery.