SAFETY OF THE BREAST IMPLANT – dentrocasa magazine, April 2012

A breast implant is a body implant consisting of a silicone casing and a silicone gel content in most cases. This device can have different shapes and volumes to accommodate as much as possible the wishes of the patient according to her anatomical characteristics.
In Europe, there are many manufacturers of prostheses regularly recognised and authorised by the competent authorities, but it is well known that a couple of these, through history and scientific research, produce high quality implants, unlike the competition that arises in a slightly lower range. All prostheses are marked with a batch number and a serial number and each patient has documentation of their implant. Although the highest quality ones are guaranteed for life, it is advisable to remember that no body implant lasts forever regardless of the manufacturing company, but it is equally true that it is more difficult to find problems with high-end products; it is also useful to underline that the choice of implants in cosmetic surgery depends exclusively on the surgeon and that each medical device is authorised by the health ministry which should establish its suitability.
In relation to the recent news regarding the prostheses of the French company Poly Implant Prothese (PIP) we believe it is correct, even though we have never used this product, to specify that this company has produced implants for over 20 years which historically have not created statistically significant problems compared to industrial competitors. Recently, observing that the number of problems related to the PIP plants has significantly increased, the French health ministry blocked their sale from 31 March 2010 and the Italian health ministry adopted the same indication from 1 April 2010. Indeed, the French company responsible for medical devices then verified that, starting in 2001, PIP used an unauthorised molecular variant of silicone. This data is not necessarily indicative of the fact that they are toxic or carcinogenic because not only have studies not been carried out on the matter, but the statistical data does not show any correlation between PIP implants and breast cancer. Even the British medical device monitoring has verified that the silicone is not compliant but it has not shown any correlation with cancer.
As often happens, the mass media are not very faithful to reality and the certifying bodies are not very reliable.
The Italian health ministry has adapted to the position of its European colleagues and performed a census of all the PIP implants performed in our country at the end of 2011.
Possible suggestions for a patient with breast implants are to ascertain the type of implant they have if they are not already aware of it, and to undergo routine checks to check the health of the breast. At the same time, the radiologist will also give indications on the prostheses suggesting an MRI for a more specific evaluation when it is deemed necessary. These rules are always valid and are even more so for patients with implantations from smaller companies.