ANSM just put online the latest reports of medical device on PIP implants. ( here )
Nothing new ... The explants continue
and adverse events:
A total of 17,135 women underwent explantation of their (s) prosthesis (s) silicone gel PIP between 2001 and the end of September 2013 (s ilo 709 women older than the end of May 2013).
Is 29,577 explants (1301 explants is higher than the end of May 2013).
The faulty PIP implants rate to date is 25.4% (7 540/29 577).
The rate of adverse events with PIP implants found to date was 16.3% (4 816/29 577).
A total of 5675 women met at least one of their dysfunction (s) implant (s) and 3047 at least one adverse effect. These numbers may not add up, even a woman can earn malfunction of the implant and adverse effects.
At the end of September 2013, 4,507 women (204 women more than the end of May 2013) underwent explantation of call sign.
Between April 2010 and September 2013, the Agency recorded 12,599 reports explantations preventive (ie 444 women older than the end of May 2013) with 11,670 with explantation dates indicated by the declarant.
In 20% of cases when preventive explantation (2525 women or women over 91 to end of May 2013), there has been discovered a malfunction of the prosthesis (broken, oozing ...) and / or an adverse effect not detected by the tests before the procedure.
A total of 74 cases of breast adenocarcinoma (4 cases is higher than the end of May 2013) has been reported to the Agency at the end of September 2013 women with silicone gel implants PIP. These tumor lesions are observed regardless of the context of the implementation (design or reconstruction).
Nothing spectacular ... Routine unfortunately!
Indeed, still no information on the exact number of implantations and women concerned ... It is interesting to note that 57% of women have made explant nearly four years after the announcement of this fraud ... We did not get an answer to this question during the last monitoring committee. ( here )
Still no epidemiological investigation ...
Still no change in the regulation of the marketing of medical devices ...
Still not delete excess fees ...
Still no compensation fund ...
Still no appointment with the Minister of Health ...
In short, the figures are published every four months and everything is fine!
But we must remain united and vigilant ... It should not be forgotten us.
Article written by Victim PIP prosthesis.
Nothing new ... The explants continue
and adverse events:
A total of 17,135 women underwent explantation of their (s) prosthesis (s) silicone gel PIP between 2001 and the end of September 2013 (s ilo 709 women older than the end of May 2013).
Is 29,577 explants (1301 explants is higher than the end of May 2013).
The faulty PIP implants rate to date is 25.4% (7 540/29 577).
The rate of adverse events with PIP implants found to date was 16.3% (4 816/29 577).
A total of 5675 women met at least one of their dysfunction (s) implant (s) and 3047 at least one adverse effect. These numbers may not add up, even a woman can earn malfunction of the implant and adverse effects.
At the end of September 2013, 4,507 women (204 women more than the end of May 2013) underwent explantation of call sign.
Between April 2010 and September 2013, the Agency recorded 12,599 reports explantations preventive (ie 444 women older than the end of May 2013) with 11,670 with explantation dates indicated by the declarant.
In 20% of cases when preventive explantation (2525 women or women over 91 to end of May 2013), there has been discovered a malfunction of the prosthesis (broken, oozing ...) and / or an adverse effect not detected by the tests before the procedure.
A total of 74 cases of breast adenocarcinoma (4 cases is higher than the end of May 2013) has been reported to the Agency at the end of September 2013 women with silicone gel implants PIP. These tumor lesions are observed regardless of the context of the implementation (design or reconstruction).
Nothing spectacular ... Routine unfortunately!
Indeed, still no information on the exact number of implantations and women concerned ... It is interesting to note that 57% of women have made explant nearly four years after the announcement of this fraud ... We did not get an answer to this question during the last monitoring committee. ( here )
Still no epidemiological investigation ...
Still no change in the regulation of the marketing of medical devices ...
Still not delete excess fees ...
Still no compensation fund ...
Still no appointment with the Minister of Health ...
In short, the figures are published every four months and everything is fine!
But we must remain united and vigilant ... It should not be forgotten us.
Article written by Victim PIP prosthesis.
FRI, OCTOBER 11TH, 2013
