What Makes Mentor CPG and Allergan 410 Implants Not Good Choices for Most?

I had a prophylactic bilateral mastectomy with immediate reconstruction in 2000. I am just unhappy with the way my implants look and feel. I have an appointment to see if I am eligible for the clinical trial now going on withMentor CPG and Allergan 410 breast implants. What makes these implants a poor choice for some people? Thank you for your time.

Doctor Answers 9

Those implants can be great for reconstruction!

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I've never met a reconstructive surgeon who has not preferred these implants for reconstruction for most patients after becoming familiar with them.

Their improved shape, resistance to folding, lower capsular contracture rates, longevity and decreased reoperation rates are among the reasons that they are so favored by reconstructive surgeons. And these are not just subjective observations: they have been demonstrated quantitatively in studies.

The problem is that they are not yet FDA approved. Yet their published 3 yr and 5 yr data surpasses that of the implants that are already approved in this country. So why are they not approved? That's anyone's guess, but the answer certainly doesn't have to do with anything scientific or demonstrable.

In answer to your question, there is one specific issue that may make them a poor choice for some people. That is the issue of rotation. These implants are thin at the top and thick at the bottom. So when the implant is properly oriented in the body, it looks more attractive and doesn't have an upper bulge/shelf/convexity. But if that implant rotates, the very characteristics that created a great shape can now create a particular deformity.

The chances of rotation in the clinical trials are very low. In fact, if you count up all types of implant malposition including rotation, such as too high, too low, etc., they are still lower with this implant than with round implants. But in order to reduce the chance of rotation, surgeons are careful to be sure that they do not put the implant in a loose envelope. That means that if you want a smaller implant than you now have, these implants may not be a good choice.

A surgeon experienced with these implants will be able to tell you if they think the risk of rotation is low enough in you to make a recommendation for this implant. These implants are certainly worth looking into.

“Gummy Bear” implants are ideal for reconstructive surgery.

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The highly cohesive form-stable implants you are describing are really ideal for reconstructive surgery. Unlike cosmetic breast augmentation, there is little to no natural cushion of breast tissue to cover the implant in breast reconstruction, so the implant itself becomes integral to the look and feel of your final results. The texture of the form-stable implants is very much like natural breast tissue, more so than either silicone gel or saline. The anatomical shape means a very realistic profile even after a mastectomy. The contours can be further refined with lipofilling, or the transfer of fat cells from your own body to the breast area to create smoother lines. Visit a board-certified plastic surgeon who offers these implants so you can feel the physical difference among implant textures and you're likely to see why so many surgeons love the gummy bear implants for reconstruction.

David N. Sayah, MD, FACS
Beverly Hills Plastic Surgeon

Shape implants for breast reconstructions

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Mentor CPG and Allergan 410 shaped implants are now approved by the FDA for breast reconstructions and augmentation since 2012. Sientra shaped implant is another available manufacturer. I prefer shaped implants over round silicone implants for breast reconstruction in my practice. In breast reconstruction, the overlying tissue coverage is very thin and thus a shaped form stable implants have less ripping deformity. Secondly, it gives a natural breast shape without a shelf or upper pole bulge deformity. And lastly, it has a lower rate of capsular contracture. I highly recommend that you seek reconstruction with a board certified plastic surgeon who has extensive experience with these implants.

Mytien Goldberg, MD, FACS
Los Angeles Plastic Surgeon

Form Stable Implants for breast reconstruction

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Just to update for new readers..........these implants are no longer on clinical trials and are available to be used for any woman. The beauty of them is there appearance and lower contracture rates. They can be an excellent choice especially in breast reconstruction. The most common down-side is that because they have an anatomic shape, there is a possibility of them rotating within the breast pocket causing them to look abnormal. This is not all that common however. When consulting a plastic surgeon about implants, inquire about the new form-stable anatomic shaped silicone implants.

Shaped cohesive gel devices for breast reconstruction are the best in my opinion!

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In an expander implant reconstruction I always use a shaped silicone device! This helps re-establish the normal contour of the breast more effectively than a round implant ever can.

Please find an experienced Board Certified Plastic Surgeon and member of the Aesthetic Society using the Smart Beauty Guide. These Plastic Surgeons can guide you on all aspects of facial surgery, breast augmentation and body procedures including tummy tucks or mommy makeovers!

Gummy bear implants for breast reconstruction

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I also agree that the use of these anatomically-shaped, textured silicone gel implants are excellent choices for reconstruction of the breast with implants.  While these two particular implants, at the time of writing this, are not approved by the FDA as of yet, there is also another company, Sientra, who also make a similar prosthetic implant.  

These three companies are the main 3 in the U.S.  Prior to Sientra, in order to have access to these implants, your surgeon had to be involved in a trial in order to offer them to you.  Therefore, many surgeons may not be comfortable with the use of them, as they have not been exposed to them during their training or while in practice.  The advantages of these include improved shape, decreased capsular contracture, decreased reoperation rate, increased longevity, and arguably, improved aesthetic outcome.  

I would recommend an evaluation by a board certified plastic surgeon experienced with breast reconstruction and these implants (if that is what you desire) to assist you in determining which procedure(s) or implant type would be right for you.  

Highly cohesive gel implants are an excellent choice in reconstruction

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We have participated in the Allergan clinical trials beginning with the dimensional 153 implant, and have continued with the Allergan 410 trial. Highly cohesive dimensional implants do have a distinct advantage in reconstruction after removal of all breast tissue. Simply put in breast augmentation a round implants works well because we are enhancing the natural breast shape and volume. The normal overlying breast imparts the pleasing natural shape to the breast augmentation. With reconstruction the breast tissue has been removed, and while the skin remains, the cover is thin, and the implant very likely to 'show through'. The personality of the breast is lost and not easily replicated with a round implant. The dimensional implant such as the Allergan 410 helps put the characteristic personality back that has been lost to mastectomy. The implant does not shift like a liquid gel, resists rippling and folding and imparts a pleasant breast shape that resists distortion by capsule formation as well. These shaped implants are the best choice for most who choose an implant after mastectomy.
Presently these implants are a poor choice for those who will not accept a silicone implant, or are unwilling to participate in the clinical study, however the effort is well worth it.
Best of luck,

Those implants may be a great option for you

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You will want to make sure the opinion you receive is from a surgeon experienced in the use of the Allergan 410 and Mentor CPG. You can get a list of surgeons participating in the FDA trials from Allergan and Mentor.

As you allude to in your question there is a bit of "mis-information" out there regarding these devices. The large majority of patients with a history such as yours may get a great result from these shaped, more form stable devices.

As some of the other answers indicate there are potential issues/concerns with all breast implants.... those issues including capsular contracture, wrinkling, rippling, malposition(too high, too low, too far apart or close together). if you look at the occurrence of these problems it is less in these devices than in the traditional silicone gel or saline devices.

Another upside to the devices is their natural shape, they are actually shaped like a breast with more fullness in the lower portion and a natural taper or contour up top. The Allergan 410 devices are available in 3 different heights and 4 different projections(the dimension from front to back of the implant). This may allow for a more "custom fit" of the implant to the particular dimensions of your breast and chest. Along with that benefit comes the potential issue with rotation of the device. Your surgeon during your exam will assess your soft tissues and discuss with you.

If you currently have smooth surfaced implants she/he may review with you creating a new pocket or space above or below. This will minimize the risk of rotation

It sounds like from your question investigating these devices will be well worth your time.

John E. Gross, MD
Los Angeles Plastic Surgeon

Gummy bear implants for reconstruction

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There are important differences between what makes an implant ideal for augmentation and what works best for reconstruction. Since a reconsstructed breast typically needs to match the dimensions of the opposite breast, the options available in terms of shape with the 410's and CPG are very helpful, so I agree with Dr. Teitlelbaum's assesment in this regard.

For augmentation, the feel and natural motion of the implant are more of a concern, along with concealing the scar. The round implants available now have advantages here since they can be placed through a smaller incision and are softer.

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.