Where are we today on Breast Implants?
Dr. Eric Plot - November 13th, 2015
As Doctors, we always feel that patients have a persistent anxiety about breast prostheses. This anxiety which appeared with the PIP scandal in November 2010 was recently sustained by the appearance of a new form of cancer that would be linked to certain breast prostheses. This concern is legitimate, so I come back here for the two big questions it raises: Are breast implants reliable and durable? Can they induce cancer risk?
CAN BREAST PROSTHESES INDUCE CANCER RISK?
Despite numerous developments, including my March 17 article on “Anaplastic Large Cell Lymphoma” and my March 31 article on the implied implant model, I have noted that there are still some concerns. Time has passed, what more do we know?
While all the attention of health organizations has been mobilized on this topic for several months, we now make two observations: the number of cases of anaplastic lymphoma reported worldwide has hardly progressed and only a specific type of implant – macro-textured prostheses – would be involved.
What is confirmed is that no other type of prosthesis is concerned, and that we are dealing with an extremely rare cancer among all cancers, a total of 173 cases of anaplastic lymphoma referenced, to report 1.7 million new cases of cancer identified each year.
RELIABILITY OF PROSTHETICS, WHY THE PIP SCANDAL HAS BEEN USEFUL The PIP scandal has done a great deal of damage to our profession. It should be known that before this case, surgeons relied on certification bodies recognized and approved by the public authorities responsible for certifying the conformity of prostheses. It would have not occurred to anyone to question such a certification body – in this case the internationally recognized German TÜV company which had certified PIP’s fraudulent breast prostheses. It was then that the trust of the patients and surgeons had been seriously abused.
This crisis made the surgeons aware that they themselves had to be involved in the control and that they must, in particular, carefully and organizationally check how the implants were made. The laboratories manufacturing the prostheses understood that the surgeons are fully part of the prosthesis validation process. So things have moved in the right direction ever since.
COLLABORATION AND TRACEABILITY TO BUILD CONFIDENCE
With my colleagues, we have set up in our societies an observatory on breast prostheses to detect any incident, so that no signal passes below the visibility threshold.
Plastic surgeons are now regularly invited by laboratories to meet their engineers and manufacturing managers. They show us all the stages of manufacture and give all the proofs of conformity of the prostheses:
- Origin and nature of the gel
- Manufacturing process
- Biomechanical studies of prosthesis resistance
- Method of sterilization of implants
In addition to the compliance check, you should know that each breast implant is now traceable. A unique referencing number ensures the traceability of each implant from its manufacture to its installation, thanks to the perfect knowledge of the manufacturer, the period and the batch of manufacture, the date of implantation, the identity of the surgeon who placed it and the patient who received it (anonymity is preserved but the patient remains identifiable in case of need).
I have personally visited a French prosthesis factory and I can testify that the manufacturers have been asking the surgeons’ opinions. A hundred plastic surgeons, including myself, were gathered by a major prosthesis producing laboratory in London recently in order to share our feedback. This partnership was well in place.
BREAST PROSTHESES ARE RELIABLE AND SUSTAINABLE
The breast prostheses that I use, whether covered with a polyurethane foam or with a micro-textured wall, are reliable. It is now established that the main cause of rupture of a prosthesis is the existence of folds on its surface which causes the attrition of the prosthesis by repeated micro-rubbing and finally its rupture. These recent progresses have solved the risk of wrinkles:
- The use of a new and very cohesive gel of stable form creating a very flexible implant which returns to its original shape whatever the stress undergone, so no fold is formed. This type of gel is also present in the micro-textured surface or polyurethane prostheses that I use.
- The use of a micro-textured envelope whose resistance to stretching or pressure is 30 times higher than most severe standards.
- The use of anatomical polyurethane prostheses that prevent the risk of secondary displacement and therefore stress on the implant.
These improvements allow manufacturers to guarantee prostheses “for life”. Today, it is no longer the attrition that can justify a change of prosthesis, it is the change of shape of the breast. When for example the loss of volume which is common during menopause makes the prosthesis unsuitable for its shape, its volume or its position to the new shape of the breast. To the reliability of the prostheses is added the safety of this intervention. There is a consensus that an implant carrier must be followed by his surgeon; I personally follow up with my patients every two years. An MRI is also performed, this powerful exam will remove any doubt about the condition of the prosthesis. Regarding breast prostheses, all the factors are there for the worry to give way to the newfound confidence. Surgeons and laboratories are working together in the service of this magnificent intervention, probably the most performed and one of the safest in the world: breast augmentation.