[Breast implants in France. New regulations, and qualitative and quantitative study of breast implants sold between 1995 and 2004].

Autor: Petit F; Cabinet médical Saint-Jacques, 46, boulevard Saint-Jacques, 75014 Paris, France. docteur.Petit@mac.com
Jazyk: francouzština
Zdroj: Annales de chirurgie plastique et esthetique [Ann Chir Plast Esthet] 2005 Oct; Vol. 50 (5), pp. 685-93. Date of Electronic Publication: 2005 Sep 19.
DOI: 10.1016/j.anplas.2005.07.013
Abstrakt: Unlabelled: 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.
Goals of the Study: 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.
Methods: 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.
Results: 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%.
Conclusion: 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.
Databáze: MEDLINE