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The MENTOR breast implants


  Since 1996 I use exclusively (with rare unique exceptions) the breast implants manufactured by the Mentor Company. At that time I took the decision based on my previous experiences, on the comparison of the documentation of different products and my studies about the international experiences and publications. I have supposed that a good quality implant, which is safe even on the long run, will help my work. Regarding only the aspects of implant quality, only two brands came into question, the products of Mentor and of McGhan-CUI, which were the leading and competing companies of the US market. By the summer of 2009 the production of the McGhan-CUI stopped, the Allergan company took over the product, the production of certain models discontinued, the manufacturing itself was placed to Costa Rica (but under the supervision of the FDA, government office of the USA), the guarantee and exchange of the previous implants became impossible. Their new Natrelle implants already have a lifetime exchange guarantee valid for implant shell rupture.

I had no confidence in implants made of unverifiable Brazilian materials either in Brazil or in Germany, unlicensed sometimes in their own country or in other European countries, and never had confidence in the debated French implants. I had no confidence in a promoter looking for market access for a new French implant, whom I asked for satisfying literature of professional experiences and he could only tell that I should simply “trust him”! It was also a standpoint for my choice, how good the support and information for patients was in comparison to others, and what the distributor service was like, meaning the provision of implant stocks for the plastic surgeon. In these times it was common (I never organized it that way) that the majority of plastic surgeons sent the patients to buy the planned implants, and only these two were available for the operation even when it turned out during the surgery, that the ideal size or type was something else. This system has also no guarantee for the rare incidents, if the implant can’t be used because it is defect, gets injured or will be simply dropped on the floor.

Earlier only the Hungarian representative of the MENTOR Company assured it for me with proper versatility and reliability that for each operation a surplus of any possible implant size and type was available all the time. Nowadays already other Hungarian implant distributors provide this service (Natrelle, Nagor, Polytech).

This requires an extensive stocking and a large investment from the distributor. The implants of the Mentor are the most expensive ones. I have never regretted their use, though temptations were plenty. Some years ago the merchant of a newly introduced French implant made the exclusive offer for me that I should pay only as much for an implant as I wanted to, even if it were 2 Forints, under the condition that I would use exclusively this implant. Obviously he wanted to take an advantage of my name to gain more confidence for the customers for the relatively new implant lacking the try out experiences. I didn’t take his offer. It is also a subjective aspect, that I would never buy a French car for myself, since I like reliability. It happened in the past years, that without informing the Hungarian distributor, a French manufacturer changed the sizing of the implants so, that identification number of the product in the catalogue wasn’t changed, and this became clear for me and for the distributor only in the course of an implant exchange of a patient, by the comparison of prior patient documentation and the new catalogue.
 
 

Different sizes of the textured, gel filled, top quality implants of the American MENTOR Company – used in our practice




Implant types NOT used by us. A so-called “smooth surface” implant in the foreground, with this one the risk of a capsular contracture is significantly higher, however the shell thickness is thinner. Left in the rear is a French implant with a low-quality surface. Right in the back an empty implant which can be filled with saline solution, the saline often leaks during the years, and if properly filled its’ touch is harder than of a good quality silicone gel implant.

 
In 2004 the Mentor had assured a lifetime exchange guarantee for their implants, extending it even with a 5 years retrospective range, meaning that they provide a free implant if it has to be exchanged due to the aging of the implant or any quality reclaim. (Certainly they don’t pay the operation cost itself.) Obviously this wasn’t valid for cases when someone got stabbed in the chest or suffered a head-on collision with high velocity and striked the dashboard of the car. Since that time the company has brought out several exchange guarantee versions with different contents, with altering restrictions in relation to time periods, and different conditions for Europe and the USA. Recently the conditions have changed on the 1st of June 2011, which we found on the homepage of the distributor like this in December 2011 (no English version available). The patient doesn’t have an easy job, if she has to find the guarantee conditions valid for her among the earlier and recent versions, according to the official Mentor website and the information of the national representatives.
Over and above, if the original implants were bought also from the Hungarian distributor of Mentor, he provided free implants in numerous cases of implant exchange where the indication was clearly aesthetical (e.g. bigger implants were more favorable in breasts which became smaller after pregnancies) – unfortunately he has progressively withdrawn this promotional offer. As stated before, there exist different exchange guarantee programs also inside the Mentor Company, with different conditions for implants placed in the USA and e.g. in Europe.

The Mentor, Natrelle, Nagor, Polytech implants have no specified “exchange” time or expiry date, namely there is no prescription to exchange them in 5, 8 or even in 10 years. Checking the Mentor implants I have implanted 10 years ago or even before with MRI (magnetic resonance imaging), the so called aging signs haven’t been found in any of the cases; while this used to happen frequently to the 10 years old or older French implants requiring their exchange, and the operations always justified these radiological findings.
 
 

MRI pictures of intact Mentor implants (left) and aging signs of some French implants (right)


I consider the sizing of the different Mentor models as good and as the most practical compared to other brands for most of the patients, in case of the most frequent aesthetic expectations and anatomic conditions. There are other brands, where the lowest implant profile is even lower than of the Mentor, and there are brands with less practical sizing for the everyday routine, because they have too much difference in height measured between two sequent profiles. I also tried the transaxillary placement (which is the most demanding for the implant shell) with other implants according to the wish of the patient, and their shell seemed to be less resistant and durable, so I was a little worried – but no damage occurred.

 

Comparing the dimensions of identical volume MENTOR implants
 

 

Comparing textured, cohesive silicone gel-filled round MENTOR implants


 
 
The anatomic (“tear drop” shape), high cohesivity model line of the MENTOR implants (left), and their sizing chart (right)


A unique technical development of the Mentor company was the postoperatively adjustable size double chamber implant with a remote injection dome for its filling, the so called Becker expander implant, useful for reconstructive procedures (e.g. oncoplastic surgery or significant asymmetry). The inner chamber can be filled and adjusted with a saline solution, and the outer chamber contains the silicone gel, that ensures a softer touch and prevents the loss of the saline solution during the years. The Becker implant provides the natural touch of the silicone gel with the volume flexibility of a saline implant and the remote injection dome can be easily removed when the expansion is complete. Most of the other companies who manufacture similar implants have the gel in the inside and the outer lumen is filled with saline, that is certainly less demanding, but these implants have a harder touch and are not durable.


 

Postoperatively adjustable size MENTOR Becker implants for breast reconstructions and for the correction of significant asymmetries


 

MENTOR skin- and tissue expander models of different size and shape


For the last 13 years in my practice I haven’t seen any sub-standard quality Mentor implants, any complications due to the manufacturing; and I haven’t found defective ones even removing implants from other surgeons’ patients. I had only one single patient, whose Mentor implants were torn to pieces and had to be exchanged after her partner had stamped on her breasts with spiked shoes. I had to exchange the injured Mentor implants for one of my patients years after she had suffered a car accident with frontal collision hitting the breasts hard. I have visited the factory in the Netherlands where these implants are manufactured and investigated. I was surprised to see that alongside the mass-production every single implant was investigated by a trained professional, and the most important steps had also the safety control and guarantee of the human eye and brain. I have seen a testing machine punching the implants 14 Million times with a 100 kp force and they were not damaged. There was no need to any technical change in the manufacturing of the Mentor implants in the last 10 years, because they proved to be time-honored and reliable.

 
   Hardwearing quality tester device of the Mentor implants (left)
Demonstrating the endurance of the implant shell in my office – I step on the same demo implants with a smooth shoe over the years (right)

 
What man creates has a “lifetime”. Humans and implants both have it. There is no exact answer for the question how long the lifetime of such an implant under average conditions is, but I believe they don’t have to be exchanged in 15-20 years like the ones fabricated 20 years before, presuming that the patient comes to controls regularly. Who wouldn’t bring the car to the workshop just for a check-up at least every second year, even if it had no problems at all? Only the ones who live and drive with great risks. It is my experience that sometimes patients can get used to the changes around the implant and don’t notice what would be obvious if a professional had only touched and examined her. The best method to check the integrity of the implant shell is not the ultrasound, but the MRI (magnetic resonance imaging), but only if the professional has a great expertise with it.

The Mentor Company didn’t ask me to write this statement, nor did their Hungarian distributor. I haven’t asked or received any compensation for it.

This paper is not a paid advertisement. This is an opinion what I’d like to give for patients as information, to make my own work easier, to summarize my experiences and personal convictions, and to answer the everyday questions in my office. I believe, that only the plastic surgeon can sleep well every night and have a clear conscience, who can be sure, that the implants he placed will give the greatest possible safety for his patients even if he wouldn’t be practicing any more.


Dr. Tibor Balajthy
Kapcsolatfelvétel