Breast implants: some have a risk of failure is too high
The French Agency for Safety of Health Products (AFSSAPS) was alerted in 2009, noting an unusually high number of rupture of breast implant pre- filled with silicone gel . While breast implants have a lifespan of 10 years, those marketed by PIP (Poly Implant prosthesis company, located in the south of France) have a risk of rupture earlier and much higher, up to two times higher than that of implants competitors. The frequency of local inflammatory reactions is also higher.
Breast Implant nonconforming unmasked
A survey in March 2010 shows an unprecedented fraud: The gel used in implants is not the one mentioned in the dossier submitted for approval to the health authorities during the placing on the market! It is not consistent and could be the cause of the fractures and other side effects of these prostheses.
Following the discovery of the fraud, Afssaps immediately ordered a withdrawal procedure and suspension of use of these implants .
Of the 500,000 women with a breast implant in France, 35,000 to 45,000 had received a prosthetic PIP. These women should consult their surgeon for a check. This may require an ultrasound examination or adapted as appropriate.Note that the implant ruptures are most often without any symptoms.
According to Jean-Claude Ghislain, Director of Evaluation of Medical Devices to Afssaps, "the number of women who may require immediate replacement is estimated at between one hundred and one thousand."
A hotline was also set up to inform and direct: 0800 636 636.
How do I know if I am concerned?
See the documents that you were given after surgery (surgical report card, implant). They report the type of implant used.
If you do not have these documents, call your surgeon.
Finally, call 0800 636 636 for further information.
No comments:
Post a Comment