In December 2013, 17,411 women underwent an explantation of their PIP silicone gel breast prosthesis, including 12,822 as a preventive measure.
In 20% of cases, during preventive withdrawal (ie 2,555 women), the doctors discovered a dysfunction of the prosthesis (rupture, oozing, etc.) or undesirable effects (inflammatory reactions) not detected by the examinations preceding this intervention.
A total of 4,928 adverse reactions were observed. These are mainly inflammatory reactions and implant malfunctions (including ruptures).
Implant dysfunctions and adverse effects encountered during preventive explantation were discovered on average 6.7 years after implant placement. But the ANSM recalls that “this median duration is only indicative, infra-clinical abnormalities may appear earlier in other patients. “
On the other hand, the ANSM did not report any case of new cancers. 74 breast cancers had appeared in women with PIP implants, but the Agency says that “they were not related to the particularities of PIP implants. “
Of the 30,099 implants removed in total, 7,634 were classified as defective. The rate of failed PIP implants remains at 25.4% to date.
The ANSM recalls “that the envelope of PIP breast prostheses is abnormally fragile, so an abnormally high number of early or very early ruptures can be expected. In addition, the silicone gel contained in the envelope is abnormally irritating: which should encourage patients to be followed closely if they do not perform preventive explantation. “
