Friday, June 24, 2011

FDA- On the Breast Implant Warpath Again

The FDA just released - who knows why - a report on implant safety. I guess they just want to beat an old horse. As a Board Certified Plastic Surgeon practicing in Fort Myers, FL, I feel compelled to comment on this report.

There is absolutely NOTHING to be concerned about in this latest released memo.

Of course the media tries to spin it in a way that is “alarming”. For example, the Boston Globe headline read, “FDA urges caution for silicone breast implant recipients.” The Wall Street Journal blogged, ” A.M. Vitals Silicone Breast implants carry risks but will stay on the Market.”

I am totally bewildered by this sudden press release/announcement, whatever you want to call it.

I have been doing implants for over 32 years and feel very strongly silicone implants are safe and represent a cosmetic surgery procedure that has one of the highest satisfaction rates.

This may have been prompted by a news release earlier in the year concerning a very rare from of lymphoma that may have a very slight increased risk with implants. This is ALCL or anaplatic large cell lymphoma. The risks are ever so slight.

One set of data cited by the FDA was the high rate of re-operation in the first 10 years after augmentation. A study done in 2006 showed a rate of 20-40%. First and foremost I tell all of my patients that their implants will NOT last forever. They are no different than a car or a lawn mower. They are devices that have a limited life time.

Secondly you have to look at the 20-40% re-operation rate and ask yourself WHY it is so high.

The casual, uninformed observers might think the complication rate is extremely high but you have to remember many of these re-operations are due to a patient's personal desire. For example, a patient who is a 32A comes in for a breast aug, has an aug that is now a nice C cup, but comes back in 4 to 5 years and wants to be fuller.

Another patient may have had an augmentation gets married, has two children and now her breasts are sagging and she needs fuller implants as well as a breast lift. Another patient may come back because after pregnancy, the ligaments that support her inframammary fold (this is where the breast meets the chest wall) may have weakened and caused the implant to be lowered (or we say it has bottomed out) so the fold may need to be re-enforced.

Many of these re-operations, i.e. 20-40%, are elective and requested by the patient and not necessarily due to a complication of the implants.

The FDA release also talks about capsular contracture. What is a capsule? First know that EVERYONE gets a capsule after the placement of an implant. This is a NORMAL body’s response to the presence of a foreign body. A capsule is nothing more than scar tissue that forms around the implant or foreign body. If you got a sliver from a piece of wood and did not remove it your body would form a capsule or scar tissue around it. This is perfectly normal.

The key thing following a breast augmentation is to keep the capsule soft-don’t let it get hard.

I instruct all of my patients post-op to do breast exercises at least twice a day forevermore. Patients who do this regularly have far fewer problems with hardness then women who do not.

I also think it is important to discuss the changing technology. Many of these studies reported by the FDA were including implant verities from 10-15 or 20 years ago. The newer implants have a cohesive gel that doesn’t migrate like the old gel implants of 20 years ago.

So, yes, implants don’t last forever and, yes, there are risks just as there are when we drive a car. But in the end analysis, they are safe and effective. It’s no wonder it is the number one cosmetic procedure. So we need to analyze this latest FDA release from a slightly different perspective.

Sleep tight all is well.


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June 26, 2011 at 7:36 PM  

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