Suspended sales of Silimed implants 

Silimed implants are produced in Brazil and are exported around the globe. Artificial products for breasts, thighs, and buttocks are some of the representative products.





It is estimated that more than 20,000 people around the world have gotten a surgery with Silimed implants.

In Europe, there is a certification organization named CE and you need to get its certification to sell implants that are used in the bodies. Silimed has this certification in Europe and also has an approval from Ministry of Food and Drug Safety in Korea.
In US, Silimed has FDA approval to sell breast and buttocks implants.




In September this year, an information tip-off has led to UK MHRA to investigate on Silimed’s production facilities and found out that there are some type of fiber on the surface of the implants.

Such finding of fiber can lead to high possibility of contamination therefore the implants are currently under a test. Also there is a temporary hold on the sales of these implants in Europe.

There is no problem with the implant in US, and people use it as usually.
In Korea, MFDS sent a warning notice on the Silimed implants. Since then, the importing companies voluntarily decided not to sell the products until the test results come out in Europe.



Safety and contamination of the implants are directly related to the health and illness of the user therefore, the safety related departments in each countries have reacted quickly to this sensitive issue.

UK’s MHRA is yet to announce its results on the Silimed implants and there is no information is the patients who used this implant have any health problems or not.
A representative from MHRA, John Wilkenson stated “This could be a result of the manufacturing process. We are looking into whether this indeed is a contamination or not.”

“As of now, we did not provide any information on what health issues the users can face and we are testing to find out what kind of problems might arise.”



We still do not know if the fiber found was only on that particular implant or on all the implants sold. The result of this testing could take about 3 months or more.




There are no problems with the Korean patients who have used Silimed products since 2012 when the products were first imported.

However, we need to stay alert for the result of this testing.
Thank you for reading. Have a great day.

Let’s look into something that you do not want to think about, but cannot completely say for sure that you can avoid it, that is side effects of breast augmentation surgery.
Before we start, let’s see if the term “side effects” is an appropriate word to use or not.



Side effect is a term used when something unexpected happens to the body due to some medication. The term ‘Adverse effect’ is also used.
But medically, we do not use the terms ‘side effect’ or ‘adverse effect’ for something that happens after a surgery.
What if your hair starts to grow after you start taking medication for high blood pressure? This is not a bad thing for you. Actually, it’s something better. It’s a side effect that you can be thankful for.
People think positively about such side effect. However, this is still a side effect. This is the reason why the term is not appropriate.
The word “complication” is the medical term used for something that unexpectedly happens to you after a surgery.
The problem is that there isn’t an appropriate Korean word for ‘complication’. Complication, for example, is when you suffer from retinopathies and another problem is added to it. It is not used for situations where you get double eyelid correction surgery but your eyes end up in original form, i.e. not double eyelid.
So, I will just use the term, ‘problems after the surgery’ although this covers a broad range of things.



Complications or problems that may be caused after breast surgery are,

1) Contracture
2) Can feel the implant
3) Visible ridges / Rippling
4) Implant moving / rotating
5) Implant collapse
These are the common complication. Today, I would like to look into these complications.

1. Contracture

This is one of the representative problems caused after breast augmentation surgery. It is different from one person to another, but contracture is caused mostly within 1 year of the breast surgery.

This is why, I check on my breast augmentation patients after 6 months and a year.
If the patient is found to have 1~2 stage contracture, then I talk with her and find out how bad it can get. If I find that it can’t get better, the solution is to conduct a simple procedure from the inframammary fold opening up the epithelium and making is a little larger.

If the patient is in 3~4 stage, then the patient and I plan on the revision. The epithelium is removed, at times completely, or one can change the location of the implant.




2. Can feel the implant 

It is possible to know whether one can feel the implant or not before it actually happens. This happens to almost everyone who is thin or have small original breasts. If you are fat or have large breasts, it would be difficult to touch and feel the implant.
If this case is bad and you want an improvement on it, fat transplantation is conducted on the parts where you can feel the implant.
The revision would be done with a smaller sized implant or artificial skin tissue can be sued to cover up the area.




3. Visible ridges / Rippling 

This happens because of the same reasons in the second case. It happens a lot to those patients who do not have much fat. Rippling happens when the breast is not filled completely and the implant wrinkles making it visible. Fat transplantation, replacement, or artificial skin tissue cover can be used.



4. Implant moving / rotating

Implant can move up, down, left or right. Also, anatomical implant can rotate clock-wise or anti-clock-wise. Small movement can be fixed with the correction bra but if there is contracture and a severe case of implant movement, then revision is necessary along with opening up the epithelium on the opposite side of the movement, finding a new location. This applies the same for the rotation. It is important to match the size of the pocket with the size of the implant so that there is no movement.

5. Implant collapse 

All the imported implants in our country are manufactured by multinational companies therefore you can be sure that all the products have life time warranty. If the implant is collapsed or damaged, you can get a replacement surgery. (This is very rare for cohesive gel implant, especially, the anatomical type)



If something unexpected happens to your breast, you might get into a panic mode. Whatever happens is not visible therefore, you cannot know what kind you situation you are in, and how to solve the problem. If you do not take any actions, but contemplate on it with the doctor for too long, you might get into a conflict with the hospital.
The problems that you might face after the breast augmentation can be divided into three groups.

First is the error or accident caused by the hospital. Some examples are paralysis after spine disk surgery or lose of sight after LASIK eye surgery.

Second is the problem caused without the error from the hospital. Getting into an auto accident after the breast augmentation can lead to opening up of the wound. Stitching up your head due to an accident, and you do not get good score on the tests.
Third is when you are not sure if the hospital is at fault or not.
There is one principle that applies to all three cases. Who is responsible for the problem caused after the surgery?




If it is clear that the supplier (i.e hospital) is at fault, then the hospital takes care of the related costs.
If the supplier is not at fault (i.e the patient is at fault or changes mind or does not follow directions given) then the patient covers the cost.
If it is difficult to determine whether the supplier is at fault or not (about 90% of all cases fall into this category), the some part of the cost is covered by the hospital and the rest by the patient.

Cases such as illegal or wrongfully done medical activity by the doctor, doctor being unaware of the patient condition, miscommunication within the hospital, missing the after surgery care are all part of the fault done by the hospital.
Cases such as misunderstanding or lack of understanding by the patient, simple change of mind, carelessness, lack to attention to guideline provided, accidents caused after the surgery are some of the faults caused by the patients.
However, it is difficult to know such clear conditions in all the problems. There are many variables involved and therefore, the supplier and the customer need to come into a conclusion.

Today, we looked at the complications (problems) that may be caused after a surgery, especially a breast cosmetic surgery. This is all for today.

Thank you very much. Have a great day.

What do you think is the size of the implant that is mostly used here in our country(south Korea)?

I looked into the implant sales data of 2013 and 2014. The result is that for all types of implants such as anatomical, round smooth, textured, the size that sold the most was 280~320cc.

Breast augmentation Korea KIES-U

 
This is quite surprising. About 10 years ago, the mostly used size was 225cc~250cc.
Many things can chage in 10 years, however it is surprising to see that Korean patients are used implants that are about 30% larger than that of the past.

The measurement data that I have collected shows that patients in 20’s~40’s that want breast augmentation surgery have average breast diameter of 10.5~11cm.


Implant should not be bigger than the diameter of the breast therefore the implants with width of 10.5~11cm are about 250~270cc and so implant with this particular volume should be sold the most. However, the data shows that 300cc implants have the most order therefore, something must be going wrong.



The more I think about it, my conclusion is that the patients are using the implants that are relatively larger than that is necessary.
I have written about the problems that may arise if the implants are too big.
1) Implant goes into the body folded, therefore there can be rippling and visible ridges
2) Low durability of implants (high collapse rate)
3) Pressure on the implant causes it to shrink in volume (contraction)
4) Severe wound and more pain or loss of sense




But such reasons do not limit the importing of large sized implants because,
1) Patients have high expectation for large volume
2) Fashion trend of wearing clothes that expose your body more
3) Greed of the doctors in cosmetic surgery

In the past, there were many who though that the large breasts look silly but now there are patients who want the breasts to be as large as possible (especially those in 20’s).
If is important that the doctor shares complications that could arise due to the usage of the large volume implants. However, such a doctor can be worried about losing the patient to another hospital if the doctor does not do what is required from the patient and therefore does what is wanted by the patient.



Swimsuits and clothes that expose your body more and more, dresses that stick to your body to show off your body lines are in fad with women in their 20’s and these ladies are showing off these physical sexiness through SNS. Such trend has led to changes in breast augmentation also.

Breast augmentation has led to customers wanting larger and larger breasts and the hospitals are allowing for this to happen. This is the reality today.


The problem is that you can change your clothes any time you want, but you cannot change the result of a surgery.
Many women think that if the original breast is 200 and if you add 300 to it, the size in total becomes 200+300 = 500.

But, as stated earlier, there is this ‘contraction’ on the implant and your original breast can decrease to 100 after 2 to 4 years. The volume would end up not as 500 but as 400 or less. When such contraction happens, your breasts would not go back to the original status although you remove the implants.

Breast augmentation Korea KIES-U

In today’s world of vast information (including the wrong ones) the doctors should not be quite about the wrong information that the patients know. One should correct such wrong information and provide the correct ones and show what is right for the patient.
But there is tense competition between the hospitals so there aren’t that many that do the right thing. In reality, there is more suspicion and concern.

This is all for today. Thank you for reading. Have a good day.

[Breast augmentation Korea] Dual Plane breast augmentation

 


Today, I would like to share about the dual plane breast augmentation.
Questions such as what implant is used, how large is the implant, and where does the implant go in through are commonly asked.

1) What type of implant is used?
2) How large is the implant?
3) Where does the implant go in?

All these three decision making factors are important, but there is one that stands out the most. It is the question of “which plane does the implant go in?”


4) Which plane does the implant go in through? 

There are 4 planes of above the muscle, subfacial plane, below the muscle, and dual plane.
This refers to the depth of the implant put in. There are many of those who do not about these planes although they are highly interested in breast augmentation.
Let’s refer to the images for more explanation.

Above the muscle

click image to enlarge

The implant is located between the pectoral muscle and the breast parenchyma. The advantages are that the implant shapes the breast and the implant is not pushed by the pressure from the muscles.
But as time passes, the upper part and the inner part of the breast become thin ending up with less tissue covering the implant. Also, it is very vulnerable to capsular contracture. The implant also gets in the way of the breast cancer x-ray.

click image to enlarge

Below the muscle

click image to enlarge

If the implant is put in below the muscle, the implant cover thickens leading to unnatural shape, rippling, and high possibility of capsular contracture. The muscle contracts and relaxes repeatedly pressuring the skin tissue causing the implant to move to another location. There can be dual wrinkle in the sagging breast as well.

click image to enlarge

Dual plane

click image to enlarge

As you can see in the image, the upper part of the implant is placed below the muscle, and the lower part of the implant is placed above the muscle.
Dual plane can cover the both the advantages and disadvantages of above and below the muscle methods.

In this dual plane method,
The implant is covered completely therefore there is no concern about the natural feel. The edges of the implant do not pop up due to the thin skin tissue. There is low possibility of implant getting pressured by the muscle. Also the chances of capsular contracture are minimized. You can also prevent dual wrinkles as well. 




There is enough skin cover at the upper part of the breasts, therefore the skin will not become thin over time.
There is no pressure in the lower part of the breast, therefore the implant would not move to another position.

Has this post helped you understand dual plane? This is a method that is very safe, and provides secure results over a long period of time without any complications or side effects.

Thanks a lot.

Breast augmentation – Inframammary fold (Incision and scar)

Anatomical implants are mostly used in breast augmentation today.



Whether you do anatomical augmentation or not, you would choose the type (round cohesive gel or anatomical cohesive gel) and the size of the implant before the breast augmentation. Next you would need to choose on the part for the incision. This is one area that you would think about a lot. I would like to share on this point to help you out.

I would like to refer to very prestigious contents. The two references below are authored by world renowned Dr. Spear and Dr. Tebbetts.



There are two competing goals in breast augmentation; providing comfortable access to the breast, while placing the incision in the most inconspicuous location possible and less exposure of scar. For many surgeons, it is the inframammary fold approach that provides the best balance between these two aspects of incision location. (Surgery of the breast, Scott L. Spear. 2006 Lippincott Williams & Wilkins)




The inframammary approach for breast augmentation is the most widely used incision location for breast augmentation. …. Reasons for popularity of the inframammary approach include direct vision for optimal control, minimal tissue trauma, and minimal bleeding. … Each of these reasons directly impacts patient outcome short and long term. (Augmentation Mammaplasty, John B. Tebbetts, 2010, Elsevier Inc.)

As you can read in the contents above, most surgeons around the world are already aware that the inframammary fold incision for breast augmentation leads to least complication and other problems providing best results. Inframammary fold approach is the most popular one in US, EU, South America.
Also, inframammary fold approach has been getting a lot of attention after the certification and sales of anatomical implants.
It is ideal that inframammary incision is done for the anatomical implants.

However, this approach is not comfortable by many surgeons in Korea. This is because many young patients preferred the axillary crease approach. I have had interest in inframammary fold and have applied it for a long time. I would like to post on some of the strong points of inframammary fold incision.

Below is the summary of different incision methods.






1) Axillary crease



Incision on the axillary crease means that the incision is done far away from the breasts therefore, it is recommended to those who are sensitive about having a scar on their breasts. However, there is no visual so we need to use the endoscope (long surgery time) and the distance from the input to the breast is long, meaning that there is that much more change of damaging the tissue of the entrance path. There can be pain after the surgery due to this cause. There are many nerve and vessel stimulants in the armpit therefore there can be some related symptoms caused. Also, it is not easy to put in form stable anatomical implant through the axillary crease and we need to study more on the possibility of implant rotation.



2) Areola



One thing that worry the patients about the areola incision is that the breast feeding may be disabled because of the areola incision. There is no such problem if an experienced surgeon performs the procedure.
Areola incision is a very good method for most breast augmentation including sagging breast and combination of 2 or more surgical methods.
However, there is a concerning point in which the incision on the breast may lead to tissue penetration causing trauma.

Also, as the implant is put in, the implant can come in touch with skin tissue cell that might lead to infection, inflammation, and even capsular contracture.
If the diameter of the areola is big enough, there would not be much problem with using the anatomical implant for areola incision method.



3) Inframammary fold 



The reason that inframammary fold incision does not cause pain is because it can be desquamated quickly. Also, it has a clear vision therefore the procedure is quick. Pain and complications are caused when there is not much visual and if one needs to damage the skin tissue.
Inframammary fold has best visual compared to any other methods and so it is the safest method as well. There is less trauma and less invasiveness.
Also, desquamation is easy and one can stop bleeding near to 100%. It is the easiest method when using the anatomical implant.
The scar can be covered by the breast skin therefore the scar is not easily visible.



4) Belly button



Belly button method leads to least pain and least visible scar that is far away from the breast. However, it is impossible to use cohesive gel silicone implant for this case. Only the saline bag type can be used. Of course, anatomically shaped cohesive gel implant cannot be used also.

 
Today, we looked at globally used breast augmentation incision method of inframammary fold.

I think that this method will be applied more and more with the usage of anatomical implant.
Also, many doctors believe that it is the safest incision method that can be applied.

Thank you. Have a great day.