Q. Should Breast implants be replaced every 10 years? 

A.



Before the FDA approval of cohesive gel in 2006, there was a time when we only used saline solution bag. The various rumors at that time are still on-line today.
What I am surprised at is that there are many surgeons who do not have sufficient knowledge about the breast implants but communicate some common sense knowledge to the patients.

Although many of these surgeons received license from the country, the surgeons, especially those who conduct breast surgery, should have updated knowledge at all times and study the respective field.

The statement that cohesive gel breast implant needs to be changed every 5 or 10 years is not true but there are those patients who ask this question saying that such statement would not have come out if it was completely false.

Rumors without any evidence tend to capture more attentions. The person who tries to communicate the accurate message may be judged falsely by the others. Today, I would like to share the FDA announcement.





In June 2011, FDA announced “FDA update on the safety of silicone gel filled breast implants”. Here are the details. (Source;http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf)



[VII. Summary of Key Findings]

1. Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use.

2. The longer a woman has breast implants, the more likely she is to experience local complications or adverse outcomes. Women with breast implants will need to monitor their breasts for local complications for the rest of their lives.


3. The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other frequent complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others. These observations are consistent with the local complications and adverse outcomes that were known at the time of approval.

4. Women with breast implants may have a very small but  increased likelihood of being diagnosed with anaplastic large cell lymphoma.

5. In the post-approval Core studies, between 20 ~ 40 percent of augmentation patients and 40 to 70 percent of reconstruction patients had reoperations during the first 8 to 10 years after they received  their implants. Although  routine replacement is not necessary, many women will  need additional surgery to modify, remove, or replace their implants.

6. There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. Associations that are very rare or that take many years to manifest may not be detected using currently available data.

7. MRI continues to be the most effective method of detecting silent (asymptomatic) rupture of silicone gel-filled breast implants.

8. Interpretation of the data from  the silicone gel-filled  breast implant post-approval studies may be limited  by low  follow-up rates.




As you can read in the 5th statement, there is no recommendation about changing the cohesive gel implant regularly


The rumor that one need to change the implant every 5 to 10 years comes from the time when the clinics used to use the saline solution bag implants and is still lasting today.

Also, this rumor is used as a marketing means in the clinics that recommend filler or fat transplantation for breast surgeries.




A scientific and accurate information is not “the information that I want” or “the information that I want to hear”. An objective information with numerical data that can be accepted by anyone would be the information that I need.

Thank you for reading the post. Have a great day.

Spreading breast when lying down (natural breast) 

Do the breasts spread apart after textured correction when you lie down? (Natural breasts / unnatural breasts)

 

The question above is about the natural look after the breast augmentation surgery
Natural breasts tend to spread apart when lying down, but the breasts with implants do not spread naturally but stay stiff- therefore, there are many who are concerned about this unnatural effect.

To share the conclusion first, the textured implant closely sticks to the breast tissue and moves together therefore, it does not spread too much outwards but it looks quite natural.

In order to give you an explanation on this, we need to share the academic trend of breast augmentation surgery.
Before, the pocket for the implant was made so that there is much space so that the implant moves about freely. So a lot of the surgeons used smooth type implant so that the implant could move in all four directions.




That is why there were advertisements that the breasts look natural because the implants spread out. There were many massages in order to maintain this space.
Many thought that such correction would lead to smooth breasts, that move about easily, and also feels good because there is much space, and also minimized the risk of having epithelium.

But, the implants moving about freely means that, if you touch the breasts then you would know that there is something artificial inside.
The implants spreading outwards when lying down are different from how the tissue inside your body spreads out. Therefore, if you only focus on having breasts that spread outwards resulting in excess spread, there is no method to fix such problem.

 


Also large pockets led to bleeding, pain, and various other side-effects. Also massaging has become one of the inconveniences caused due to the correction.

The trend today is to have just enough pocket size fitting for the implant. This is to prevent any side effects that may be caused by limiting the size of the pocket. (The term “24 hour recovery system” came out from this aspect)

Textured breast implant is most appropriate for minimized pocket size. Also, you would not need any massaging after this
 



There are some internet advertisements that say that you do not need massaging because of the textured breast implant. This may lead to some misunderstanding.
Minimized pocket space for the correction leads to avoiding the massages. It is not because of the textured implant.
Also the textured implant sticks to the skin and moves together with the skin so one must avoid massaging. (Massaging is to separate the implant from the skin).

Therefore, minimized pocket size, textured breast implant and no massage have become a trend. In such case, you would have breasts that spread out as much as those on the picture below.




Also, the advantage is that if you touch the breast, the implant moves along with the breast so you will not be able to feel that you have the implant.

The extent to how much your breasts spread with textured would be definitely less that the smooth implants.

But, if you are concerned about
How long will the natural shape last?
Will the volume of the breast remain the same although I get old?
Is there no problem of defect?

Then, you would not have to worry as much. These are the contents that are more important. The cohesive gel product of Anatomic shaped textured implant is the one product most fitting.

Thank you for reading.

Power ptosis correction - Korea

Many patients ask how KIES-U Korea’s power ptosis correction is. The explanation can be provided with images below.

A normal person’s eye looks as below.






[Location and the structure of the muscle that opens the eye]




Power ptosis(eyelid) correction is an advancement on the muscle (2 layers) that opens the eyelid (Levator palpebrae superiosis muscle on the upper side and Muller muscle on the lower side)

[Power ptosis correction: Pulls and fixes the 2 layer muscle that opens the eye] 

Power Ptosis(eyelid) correction

As you can see in the image, the muscle that pulls up the eyelid moves towards the inner part of the eye making it shorter. Although the strength required to open the eye is stable, the eyelid moves more upwards if you open the eye. The side vies of this activity can be seen in the image below.

KIES-U Korea - Power Ptosis correction

Usually the ptosis correction only involves changing the levator palpebrae superioris muscle but there would be no changes before and after the correction and you may need to have a second correction.

The most effective way would be to pull the Muller muscle and levator palpebrae superioris muscle together and fixing the position so that the eye becomes bigger.

Kies-U’s power ptosis correction is fixing the location of the double layered muscle so that the eye would remain bigger for a longer period.

Thank you for reading.

Breast augmentation massage 

Massaging is to maintain the large space around the breast implant

Many surgeons believed that in order to reduce the capsular contracture, the pocket needs to be larger than the necessary size so that the massaging would be able to maintain the large space of the pocket in order to move the breast implant.

This would prevent the breast implant being adhesive, minimizing the risk of epithelium tightening.
Also, when the patients lies down, the surgeon think that it is good if the breast implant spreads outwards so that it looks natural on the person and the patient would like this.

However, having this large space leads to much problems.
1) The range of the surgery becomes larger causing that much more wounds, pain, inconvenience, and other complications while recovering.
2) At times, when a patient lies down, the implant spreads more that it is supposed to.
3) It looks better if the two breasts come together closely when standing up, but large space might lead to wider separation of the breasts.
4) Also there is no clinical data that massage leads to less capsular contracture. (It means that massaging has no effect)
5) The most important fact is that one cannot control the implant to be at the most appropriate position. The large space makes it difficult for the implant to be located properly leading to deformation of the breasts.





In other words, if the pocket space is large, then the correction must be done on the larger space than anticipated, leading to higher possibility of side effects, and lower accuracy in estimation of where the implant would be located after the correction.

It is not always the case that the breast implant has to be placed in a large pocket in order to look natural and feel good. Although the space is not large enough, the implant can feel more natural just by the movement in the area where epithelium and the tissue meet.

The large space does not minimize capsular contracture and does not lead to greater satisfaction of the patients.

Clinical results from the implant positioned exactly in the appropriate space (diameter)
 

Type of Implant	Duration	Possibility of Capsular Contracture
Natrelle textured water-drop type saline solution bag implant	7 years	0.7%
Natrelle textured water-drop type silicone gel implant	3 years	0%
Round smooth saline solution bag implant	5 years	Similar to large dissection

There is no difference in the possibility of capsular contracture between small pocket size that leads to less bleeding, and more accurate correction compared to that of large space.

Also, the small space leads to accurate firm positioning of the implant avoiding any movement of the implant and reducing the recovery period.




Today, many clinical results show that whatever type of implant is used, it is important to do the necessary and accurate amount of dissection, and not massage unless it is needed. This applies to both textured and smooth types.

Thank you for reading, have a good day.