The PIP prosthesis scandal has not deterred women from getting silicone breast implants. They are now around 340,000 to wear (or to have worn) in France, according to an ANSM report on the use of silicone breast prostheses from 2010 to 2013, published on Tuesday. Since 2001, more than 610,000 breast implants filled with silicone gel have been sold in this way.
The ANSM publishes reassuring conclusions on the basis of inspections and controls carried out in the eight companies which market silicone breast implants in France. “The implants taken did not show any non-compliance likely to pose a risk to the health of the patients,” she says.
No fraudulent situation was observed. Only Cereplas had to temporarily suspend its activity due to a lack of validation in its production process. In this case, this incident did not affect the quality of the prostheses.
Reported incidents
The ANSM lists the incidents notified over the period 2010 to 2012. The ruptures of implants concern 65% of the reports (1,148 cases) made to the health agency. The other problems recorded relate to the formation of shell, folds, waves or rotation of the prosthesis, inflammation, infections, or the perspiration (oozing) of silicone. The rate of ruptures of prostheses is very low (from 0.01 to 0.30% depending on the duration of implantation).
Although 22 cases of breast cancer have been reported, this figure does not allow us to conclude that there is an increased risk of breast cancer compared to the general female population.
Recommendations to prosthesis wearers
The agency insists on the importance for women candidates for the placement of implants to be well informed with their surgeon. He must explain to them the risks of complications associated with the surgery and the placement of implants. He should also remember that breast implants have a limited lifespan (7 to 10 years), which implies “one or more other interventions after the initial placement”.
The ANSM also recommends regular medical monitoring, in particular to check the integrity of the breast implant.
