PIP BREAST IMPLANTS: The patient's health first of all

Today there is a valid alternative to breast implants: autologous Adipose Tissue grafting

Considering the facts occured in France related to the use of silicon breast implants produced by Poly Implant Prothese (P.I.P.), as well as the stir and scandal spread in the last few days all over the country, creating in many cases unnecessary panic, we would like to reassure Dr. De Fazio's patients who have had a Breast Augmentation surgery.

In fact, Dr. De Fazio's professional and quality standard, together with his care for the patients, have led him to use only the best products available on the market, like breast implants certified and guaranteed, and bearing the CE Marking, thus with the manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation (D.Lgs 46/97).

In 2010, following an increase in reports on accidents with PIP implants, the French Healthcare Regulatory Agency, the "Agence Francaise de Sécurité des Produits de Santé" (AFSSAPS), carried out an in-depth investigation about the implants, which showed that the silicone gel used for the production of PIP Implants had a different content than stated in the technical data sheet. Hence, the silicone gel did not have the compositional characteristics for the intended clinical use, and, furthermore, the implant shell appeared to be very defective, with a high risk and incidence of rupture.

During the period following the investigation by AFSSAPS, PIP went bankrupt.

The malpractice carried out by PIP damaged both the patients and the plastic surgeons. In other words, they were both victims of it.

On 16th December, 2011, AFSSAPS published a report confirming 8 cases of breast cancer (malignant breast neoplasm) in patients with a PIP breast implant. (www.afssaps.fr)

The French Healthcare Regulatory Agency, however, has explained that no causal link has been determined between the diagnosis of the disease and the PIP implants.

In Italy, about 4.300 women have received these implants and the Italian Ministry of Health (Ministero della Sanità) has confirmed to take the costs to remove the breast implants for those cases with a specific medical-clinical indication. The Minister of Health, Mr. Balduzzi, has ordered to all Health Facilities in the country performing this kind of surgery to communicate a list of patients who underwent breast surgery with PIP implants.

Nevertheless, the Board of Health (Consiglio Superiore della Sanità) has stated that these implants can cause only rupture problems and, as a consequence, inflammations and, therefore, invites all women wearing PIP implants to get more information about the risks.

Protecting the patient's health and well-being, not only form an aesthetical point-of-view, has always had the highest priority for Dr. De Fazio, who will keep offering his co-operation and support to the patients who need to be reassured.

Furthermore, Dr. De Fazio has successfully performed for many years breast augmentation by lipofilling with autologous Adipose Tissue , a valid alternative to breast implants, for the patients who prefer a more natural result and a less invasive procedure.
It is also a very good alternative for the patients who would like to replace the PIP implants without getting a new implant.

Likewise, in order to avoid unnecessary alarm, we would like to remind that breast implants are medical devices getting great attention from the internatinal scientific community, with more than 3000 studies published per year. Within the international scientific context, breast implants are considered safe and have been used more and more frequently over the last 50 years.

To keep yourself updated on this issue, please visit the Italian Ministry of Health (Ministero della Sanità) website (www.salute.gov.it).



Alessandra Damaschino

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