Wednesday, March 14th, 2012
Today the Food and Drug Administration (FDA) approved Sientra Silimed brand silicone breast implants. Up til now, the only approved manufacturers of silicone gel breast implants available for use in the United States are Allergan and Mentor. Now, Sientra enters the market as the third such approved manufacturer.
Like Allergan and Mentor, Sientra was required to submit several years worth of data to the FDA before consideration could be given to the approval of their product. And like the other two manufacturers, Sientra will be required to continue to submit data to the FDA as part of ongoing study of these devices.
I believe that competition is a good thing here. It will ensure that all three manufacturers will strive for the best quality product and the most competitive price, and the consumer will benefit from this competition.
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!
Friday, September 23rd, 2011
Last month, the Food and Drug Administration (FDA) met to evaluate current information regarding the safety of silicone gel filled breast implants. William Maisel, MD MPH, chief scientist for the FDA center for devices stated that silicone gel implants were safe. In Nov, 2006, after 15 years of scientific study, the FDA approved silicone gel filled implants for use in this country. This was followed by a recommendation (not a requirement) that women undergo MRI exams three years after surgery and every two years thereafter to evaluate their breasts for silent rupture of the implants. MRI exams used for this purpose are expensive and it is believed by many that these MRI studies probably will not be paid for by most insurance carriers. It was not clear what scientific basis was used to create this recommendation. Many plastic surgeon, myself included, believed that this was excessive, expensive and not justified. Please see my previous blog: Silicone Breast Implants – Are routine MRI’s really necessary? (February 21, 2011). During the recent meeting, the FDA removed this recommendation. Current scientific evidence clearly supports the safety of silicone gel filled breast implants.
Certainly, if a woman has undergone breast augmentation with silicone gel implants and has a problem with their breasts such as breast pain, change in shape, appearance or feel of their breasts, or develops a mass in their breasts. They should see their physician. In these cases, an MRI may be necessary to evaluate the health of the breast. The current FDA withdrawal of the recommendation for routine breast surveillance with MRI’s applies to women with asymptomatic breasts.
The conclusion of multiple epidemiologic studies is that there is no connection between silicone gel breast implants and connective tissue diseases (i.e. rheumatoid arthritis, scleroderma, lupus) nor is there a connection between silicone gel implants and breast cancer.