The American Association of Aesthetic Medicine & Surgery (AAAMS) wants to communicate to patients carrying the PIP prosthesis, surgeons who have implanted responsible health authorities and associations affected their position on this issue that affects us all.
The US Association of Aesthetic Surgery – scientific organization formed by plastic surgeons members of the American Society of Plastic, Reconstructive and Aesthetic SECPRE whose main activity is the Cosmetic Surgery – wants to send a message of reassurance to women with breast implants PIP brand.
After the evaluation and study of all the data available at this time we report that NO has been established a cause-effect relationship between PIP implants and cancer cases found.Moreover, according to the expert group of French National Cancer Institute (INCA) the number of breast cancers reported among the PIP implants are less than the rate observed in the population.
However, following the criteria of the French Ministry of Health, societies in which AECEP out: ISAPS (International Society of Aesthetic Plastic Surgery) and EASAPS (European Association of Societies of Aesthetic Plastic Surgery), and Ministry of Health in other countries, the AECEP advised, as a preventive and non-emergency, removal of all implants of this brand, both showing signs of breaking as the upright.
We believe this measure should be taken and monitoring the evolution of these prostheses to remove only those that show signs of breakage, because the preventive withdrawal greatly facilitates the process of explantation significantly reduces cost and, especially, if they withdraw the prosthesis before the break, avoid contact of gel with the body, especially when it is known irritant capacity of the silicone gel inadequate.
The AECEP, moreover, is clearly positioned beside the patient and surgeon, both elements homeless in this process.
The patients, who have encountered a problem that no one expected: premature failure, inflammatory reactions and, above all, a health concern heightened by the media.
Plastic surgeons, because we suffer directly the anguish of our patients and, without any blame, we are immersed in a conflict of significant economic impact for the mere fact of having used some implants that meet all legal requirements and with the clearance from health authorities:
- The French Health Security Agency of the drug and health products (AFSSAPS)
- The approval of the European Community by TÜV Rheinland certification by Cologne quality watchdog Europe, issued on 13/12/2007 and expires on 7/12/2012
- U.S. Department of Health and Human Services through the American Agency of medicamneto and health products (Competent Authority).
However, to the relief of both women who have had PIP implants and those who are still with these valves, we must make clear that all studies to date have not demonstrated that there is an increased cancer risk associated with these prostheses .
In this sense, the results obtained by the U.S. Department of Health through the American agency of medicine and health products (Competent Authority), the April 14, 2011 reported that both in vitro and in vivo genotoxicity showed negative results that lead to the conclusion of absence of genotoxic effects on cells or their DNA, ie not alter genes and, therefore, not produce cancer.
Similarly, the Committee of Experts of the AFSSAPS (French Agency of Health Security) met on 22 December by the National Cancer Institute (INCA) has confirmed these findings and confirmed the power-irritating gel and a fivefold increased risk of rupture. Earlier, on September 28, 2010, the US agency of medicine and health products (Competent Authority), after conducting preliminary studies on samples obtained from the manufacturer, reported that the gel-filled breast implants PIP does not correspond with that described in the design dossier of the manufacturer and does not reach the quality level required for a silicone gel for use in breast implants (physico). Furthermore, the mechanical tests showed the fragility of the prosthesis that justifies the findings of a higher failure rate than average.
Regards testing of biocompatibility with biological tissues refers that the gel breast implants PIP presents no acute toxic effects in tissues (cytotoxicity) although if shows an irritating behavior when placed in contact with the tissues due to breakage of the membrane, which can lead to inflammatory reactions in some patients. It also shows a significant heterogeneity of the products so that all implants do not present the same level of quality.
PROTOCOL FOR ACTION
- The women with breast implants should check through your surgeon, card implantation, clinical report or facility which performed the surgery if your dentures are brand PIP.
- If they recommend the withdrawal PIP prosthesis, as a preventive and without urgency, of all implants of this brand, both showing signs of breaking as the upright.
- Contact any of the platforms affected by PIP prostheses.
- Before the withdrawal, both the broken prosthesis as the integrity, must go to the plastic surgeon who operated it prompted the preoperative clinical examination and appropriate radiological (breast ultrasound and axillary control and, if necessary, magnetic resonance ( RM). We must be advised to avoid mammograms because the pressure could break the prosthesis still intact.
- If not broken the treatment is simple, remove the PIP prosthesis and replaced by others of a different brand.
- If broken or is suspected rupture or extravasation treatment, of course, consist of the removal of the prosthesis, but the action will depend on your surgeon and must agree with him.
- In case you do not want the removal of the prosthesis is advised breast and axillary ultrasound monitoring every 6 months.