Monday, December 26th, 2011
On March 30, 2010, France’s health regulators issued a recall of all pre-filled silicone breast implants manufactured by Poly Implant Prothese (PIP), a company based in southern France. The breast implant recall is said to affect an estimated 35,000 to 45,000 women worldwide.
AFSSAPS, the health regulatory agency of France, discovered an unauthorized type of silicone gel being used in the pre-filled implants. Following the recall, the French court ordered the company to shut down entirely for the manufacturing of fraudulent implants.
NOTE: THESE IMPLANTS WERE NOT USED IN THE UNITED STATES. WOMEN WHO HAD BREAST AUGMENTATION IN THE UNITED STATES DO NOT HAVE TO WORRY ABOUT HAVING THESE IMPLANTS. IMPLANTS USED IN THE U.S. ARE MANUFACTURED BY EITHER ALLERGAN OR MENTOR AND ARE HELD TO THE HIGHEST OF MANUFACTURING STANDARDS. IT IS MY UNDERSTANDING THAT THE SILICONE GEL USED BY PIP WAS NOT MEDICAL GRADE SILICONE.
The following is from the American Society of Plastic Surgeons (ASPS):
ASPS, French society working together to monitor developments on PIP silicone gel breast implants
The American Society of Plastic Surgeons has been monitoring the developing situation in France regarding suspected defective silicone breast implants manufactured by Poly Implant Prothèse, a company known as PIP, that was required to halt production of the implants in 2010.
Thanks to our colleagues at the Société Française de Chirurgie Plastique Reconstructrice et Esthétique (French Society of Plastic Reconstructive and Aesthetic Surgery) with whom ASPS signed a Memorandum of Understanding in 2010, we have been receiving real-time information from plastic surgeon leaders in France.
At this time, we would like to inform all U.S. domestic ASPS members that, to the best of our knowledge, PIP silicone gel-filled implants were never approved for use in the U.S. An American woman would need to have been implanted outside the U.S. in order to have received the implants that are now the subject of concern in France.
For our international members, we believe that while the current focus of attention is in France, approximately 80 percent of PIP implants were exported to other countries including the U.K., Spain, Brazil, Argentina, Chile, Colombia and Venezuela. There are also reports that implants under the brand name “M” distributed by a Dutch company in Germany and possibly elsewhere in Europe may also be PIP implants that were rebranded as M implants.
An official decision by the French Ministry of Health as to whether an estimated 30,000 French women with PIP silicone implants will be advised to have their implants explanted is expected on Friday, December 23rd. Other European health ministries appear to be awaiting the French decision before deciding on their own courses of action.
ASPS will continue to monitor the situation and keep its members informed.
Sunday, December 18th, 2011
In 2002, my good friend, colleague and mentor, Dr. John Tebbetts described an entirely new approach to breast augmentation. His procedure, which yielded a recovery from breast augmentation in 24 hours, is radically different than current breast augmentation techniques. What he created is a system for breast augmentation that is based upon the measurement of breast tissue parameters and a minimally traumatic surgical technique with almost no blood loss whatsoever, minimal discomfort after surgery and a negligible re-operation rate. This facilitates the patient to be able to typically recover in just one day! This system is reproducible among other surgeons who have learned his technique. In other words, those who use his techniques achieve virtually the same results with their patients as the creator of the technique. It is based upon science, not guesswork.
Features of this technique include the following: Narcotic pain medication (i.e. Tylenol #3 or #4 with codeine, Percocet) is not necessary. Only Advil (ibuprofen), an anti-inflammatory is required. Patients often go out to dinner, shopping, and visit friends the same day as their surgery. The next day, they are driving and doing other normal activities of daily living (except strenuous exercise). On the day of surgery, if so inclined sexual activity is permitted and you may lift up to 25 pounds. There is no dressing other than a small piece of surgical tape or steri-strip on the wound. No special bras, wraps or other garments. No pain pumps. No need for infusion of local anesthesia into the breast tissues (long acting local anesthesia only lasts about 4 – 12 hours max). Immediately after surgery (and I mean while still on the recovery room stretcher!) you can raise your arms high above your head. Discomfort is usually nothing more than a sense of “tightness” (that is what my patients call it), rather than pain.
In June, 2004, Dr. Tebbetts personally taught me this technique. Since then I saw an immediate shift in my patient’s recovery from one of pain, narcotics and slow recovery to the quick and easy recovery as described above.
There are other benefits to recovering in one day that most people do not think about when considering breast augmentation. Occasionally, a second surgical procedure called a “revision” is required to fix some issue arising from the first surgery. This might be an adjustment of the breast pocket that the implant lies within, treatment of a capsule contracture (scar tissue thickening around the implant), changing implant size or some other issue. Re-operation includes revisions as well as all other reasons for re-operation such as bleeding or infection after surgery. The pre-market approval (PMA) studies submitted to the FDA for clearance of silicone breast implants demonstrated a 15% and higher re-operation rate at 3 years. This is simply unacceptable! Dr. Tebbetts published a study indicating his experience, achieving a 0% re-operation rate in 50 consecutive patients with his technique.
As of this writing (April 2011), my three year re-operation rate is less than 2%, one tenth of the rate in the national PMA studies. One of the more common reasons for breast augmentation is capsular scar tissue contracture. To date, I have not had one such complication on my silicone augmentations; the last one I saw in my saline augmentations was in 2006.
On rare occasions, a patient may still require a narcotic pain prescription. I collect information regarding recovery from all my breast augmentation patients. Over the past two years (2009 and 2010), 97.5% of my patients did NOT require any such medication. In some cases, the few who did require narcotic pain medication did so because they selected an implant larger than I recommended based on my analysis of their tissues, and naturally, it is anticipated that more postoperative pain will result. Despite this, 100% of my patients during this two year time period achieved a 24 hour recovery as defined above.
If you are looking to have breast augmentation and wish to have the best possible technique is the way to go. Dr. Tebbetts and his wife and patient coordinator, Terrye Tebbetts, wrote a wonderful book that every woman considering breast augmentation should read called The Best Breast 2 (it’s the second edition) and can be obtained from Amazon.com.
Now, how do you know if your surgeon performs breast augmentation so that you can recover in one day? There are many surgeons around the country who perform breast augmentation procedures espousing quick recoveries. Just ask the surgeon if the following is true for his patients:
-Narcotic pain relievers, sedatives and muscle relaxers are NOT needed nor prescribed
-Local anesthetics are not required
-No pain pumps, nerve blocks, drains, binders, special bras are used
- No limitation of normal activities from the evening of surgery (aerobic activities excluded)
-Patients can routinely place their hands high above their heads right after surgery
-Breast implant size will be determined by precise measurements of your breasts coupled with detailed assessment of your breast tissues
- The surgeon will provide you with several patients that you can speak to who underwent the procedure
Many patients ask what it is that I do differently than other surgeons. The answer is that it is not just the surgical technique using specialized surgical instruments of my own design Epstein Breast Retractors), but also the entire process of decision making and instructions from patient consultation through recovery
There are many surgeons using a multitude of names for their surgical procedures, but there is only one way to achieve a recovery within such a short time period. I use the term “One Day Recovery Breast Augmentation.” If the surgeon cannot assure you of the above, then you will not most likely not attain a recovery from breast augmentation surgery within 24 hours.
Sunday, December 18th, 2011
Occasionally, during consultations, my patients have particular ideas about which implant profile they would like. For those of you who are not sure about what I am referring to, implant profile describes the way the volume within an implant is distributed in terms of its base width and the height (forward projection). A low profile implant is widest with the least amount of forward projection, and an extra high profile has the narrowest base width and the greatest forward projection. The base width is important also, because this is what gives you the desired “lateral projection” where the outer breast contour protrudes to the side of the chest to balance the width of the hips and give you the feminine. hourglass shape that women so desire.
So it would seem that many women would desire the extra high profile so that their breasts protrude forward the most. I tell my patients that on a computer screen during simulation, I can make their breasts protrude as far forward or as wide as desired. The reality is that this is nor practical nor desirable. Let’s look at the anatomy. The breast consists of the skin envelope which contains the mixture of glandular and fat tissue within the breast, also known as the “parenchyma” of the breast. All this sits above the pectoralis major muscle (see the diagrams in the “Implant Fundamentals” tutorial http://www.breastimplantslongisland.com/breast-implants-101.php ). So, if you place an implant under the muscle, the implant has to contend with the muscle, the breast parenchyma and the skin, all of which have to give way and move forward under the implant which is pushing them forward. The resultant breast size and shape is due to the sum total of the implant placed below and the existing breast tissue (and pectoralis major muscle) above.
Now, let’s look at the physiology of the interaction of the tissue and the implant. With all implants, I think it is safe to assume that there is going to be some atrophy (loss of parenchyma) of the breast. The more pressure from underneath, the more atrophy. If there is little pressure, then there is little atrophy. If there is a great deal of pressure, then there is going to be more atrophy.
Let’s talk about the high and extra high profiles first. I will lump them together for the purpose of this discussion, as my feelings about them are similar, but more strongly in the case of the extra high profile. These implants exert a fair amount of pressure to the underside of the breast. The atrophy can be substantial. So look at it like this, the more you think you are gaining with the higher profile, the more you are losing from your own tissues. So the gain is not as much as you might think. Besides the atrophy from the higher profile implant with resultant thinning out of the overlying breast tissue, there can actually be anatomical changes in the underlying chest wall – the rib cage. These changes can actually result in a depression of the rib cage, which, aside from being unnatural in appearance, also serve to reduce the net forward projection of the breast. This is an uncorrectable deformity.
In my extensive experience, I find that the medium profile implants work well in most cases…an excellent balance between width and projection. This results in beautiful, natural, aesthetically pleasing results.
What about low profile implants? When do I recommend them? Sometimes, the breast tissues are very tight and do not move forward as well as desired. This is common in some women with tight breast skin, little breast parenchyma – typically an “A” or an “AA: cup size who have never been pregnant, and even in some who have borne children. In these cases, sometimes even a medium profile implant might result in more pressure on the breast tissues then desirable. This is a great indication for a low profile implant. One might think that this will result in a breast that is disappointingly small or lacking projection, but in reality, the results are quite nice and aesthetically pleasing.
The take home message here is that in order to obtain the best breast which I define as the best shape and size, the greatest longevity of that shape, the least amount of tissue overstretching, the least degree of atrophy, the least damage to the nerves with loss of sensation of the breast, and the best chance of a 24 hour recovery, one must match the implant to the breast tissues. Neither you, nor your surgeon can force the breast tissues into a shape and size that they are not designed to accommodate. This means that in some cases, the patient may not be able to be the exact size they have in mind, but she will be rewarded with a beautiful, aesthetically pleasing result with longevity and recovery from surgery in 24 hours!
Thursday, December 8th, 2011
I have been asked by many patients about the length of the incision for a breast augmentation. Recently, one plastic surgeon has been advertising on the radio about his new “Stealth” incision technique. What is the story??
The bottom line is that all patients want as inconspicuous a scar as possible. This makes sense. What determines this? Certainly, incision length is a factor, but not as much a factor as you might think. The importance of these factors varies between individuals, so I can’t rank them specifically. However, I would list the factors that go into the visibility of a scar as follows:
1. Quality of the scar (flat, raised, or keloid) – this is determined by the biologic makeup of the individual patient and cannot be altered.
2. Location of the scar – different places on the body show dramatic variation in the tendency for the scar to be visible.
3. Orientation of the scar – If the scar follows the natural lines of tension, the scars tend to be better. Scars located in creases (such as the lower breast crease) tend to heal very well and be much more inconspicuous.
4. Tension of the scar as it heals – If there are mechanical forces acting on the scar as it is healing, the scar tends to widen, thicken and become more conspicuous.
5. How the tissue was handled during surgery – lay people and believe it or not, most surgeons do not appreciate this factor. If the wound edges are traumatized during surgery by excessive force (such as when trying to do a procedure through an incision that significantly reduces the surgeons ability to visualize what he is doing, the tissue may not heal as well as desired.
6. Length of the scar – A longer scar is more visible than a shorter scar, but a longer scar of better quality will be less conspicuous than a shorter scar of poorer quality.
7. Method of closure – how many layers of closure, what sutures are used, type of suturing, how delicately the tissue is handled.
All of this said, how do I plan my incisions for breast augmentation? I will restrict this discussion to silicone implants as they require a larger incision than saline implants as they are pre-filled by the factory and saline implants are inserted deflated, rolled up like a cigar and inflated once inside the breast.
Allergan, one of two manufacturers of mammary (breast) implants states in their product literature that the incision should be of sufficient length to place the implant inside the breast without risking damage to the implant. When inserting a silicone gel filled implant into the breast, the implant is deformed to enter the breast through an incision smaller than the base diameter of the implant. But how much smaller? The answer to that depends on the size of the implant. A larger implant requires a larger incision. If you force a silicone gel implant through an incision too small, the implant will either burst on the spot (I once witnessed a colleague do this) or more likely it will weaken the shell (the bag) of the implant and potentially shorten its lifespan. In my practice, I make my selection for implant size prior to the day of surgery, so I know based upon experience how long an incision to make so as to comfortably insert the implant and not have to worry about shell damage. For implants 200 – 300 cc, I usually use an incision size around 4.6 – 5 cm, for implants 300 – 400 cc I use an incision size approximately 5 – 5.5 cm, and in the rare case that I need to place an implant larger than 400 cc, a larger incision may be required.
That said, there is more to planning an augmentation to achieve a minimally visible scar than the length of the incision. I already stated that if the scar is in the lower breast crease it will be less conspicuous. So all the surgeon has to do is place the incision in the lower breast crease and he is guaranteed a less conspicuous scar, right? WRONG!!! Remember, we are enlarging the breast which means the diameter of the breast will increase. Depending upon the tissue characteristics of the breast (that’s a whole other discussion); I may elect to actually make the incision lower than the lower breast crease. Why? If you make the incision in the lower breast crease, and then place an implant such that the lower breast crease must now be lowered so as to position the implant properly behind the breast, then the initial breast crease incision will now be riding up on the lower portion of the breast, well above the crease, in plain sight and with more tension on the wound edges during healing. All this is a setup for a visible scar. So what do I do that is different? Taking into account the tissue dynamics of the breast, precise measurements of the breast are made. Knowing the size of the implant to be used prior to the start of surgery I can now plan where the desired, new lower breast crease will need to be and place the incision in that position so that the scar will lie within the new breast crease after surgery. This is a much more significant step in reducing scar visibility that merely trying to struggle through an incision too small to work through and insert an implant comfortably.
As far as closure is concerned, I use a three layer technique with all dissolvable sutures. The outer layer is a very fine suture and no removal of suture material is necessary.
The conclusion is that planning an incision to lie within the new lower breast crease using an incision that is just long enough to permit adequate visibility to the surgeon and prevent implant shell damage makes much more sense that struggling through an inadequate, shorter incision and risking damage to the implant.