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.
Thursday, April 28th, 2011
Welcome to my dedicated breast augmentation web site www.breastimplantslongisland.com .
I have maintained a plastic surgery web site www.epsteinplasticsurgery.com since 1999. The purpose of my web sites is to provide information to the viewer about the plastic surgical procedures that I perform. In my opinion, a web site without worthwhile content, or information of benefit to the viewer is nothing more that a billboard to try to increase the flow of patients into a practice. I have always believed in patient education and involving the patient in the decision making process. In order to do that, there has to be a dedicated effort to make available useful educational material on the web site.
Breast augmentation is somewhat unique in plastic surgery. Unlike most procedures, the patient is electing to have two foreign bodies (the implants) placed permanently into her breasts. Round or teardrop, smooth or textured, saline or silicone, above the muscle or below the muscle, low-medium-high or extra high profile, incision below the breast or around the nipple or in the armpit or through the navel are just some of the choices to be made.
In my opinion, there are many good web sites out there with useful information, but I have yet to see one as comprehensive as I felt necessary to give the viewer one good resource to use in preparation for their upcoming consultations.
There are some really great advances in breast augmentation surgery. In 2001, John Tebbetts, MD described a method of breast augmentation that radically changed the surgeons approach to breast augmentation from one of “guesswork by experience (or lack thereof)” to a scientific method that is reproducible. The end result of this process was the ability for the surgeon to have such control over his results that revision rates which were typically 15 – 40% in several studies are now only a few percent or less. Patients are recovering with little discomfort – most of my patients describe the discomfort as “a sense of tightness” rather than pain. They recovery in just 24 hours or less. When I visited Dr. Tebbetts in 2004, I was, to say the least, flabbergasted by what I saw. I never dreamt that women could undergo such surgery and recover so easily. Armed with the knowledge I obtained from Dr. Tebbetts in Dallas, I set out to return to Long Island, NY and develop a center that could produce similar results as I saw in with Dr. Tebbetts.
Initially it was hard to convince women of the recovery after surgery. Typically, women who undergo breast augmentation had severe pain, required narcotic pain killers and required weeks to recovery. But this was no longer the case! Now, seven years later with hundreds of women who have undergone this technique of 24 hour rapid recovery successfully, no one doubts the recovery. The web site has far more on this topic.
In November, 2006, the Food and Drug Administration had cleared silicone gel filled implants once again for use in breast augmentation. Silicone gel implants are far more natural in feel and have less rippling and wrinkling than their saline counterparts. This was a major step in improving the quality of results in breast augmentation surgery.
In July 2009, I brought into my practice a fairly new technology. The Vectra 3D is a computer based three dimensional imaging system. It takes a three dimensional photograph called a “surface” of a woman’s chest, and then allows manipulation of the image. With a preprogrammed library of breast implants, the surgeon can then have the computer “simulate” the results of breast augmentation surgery. Are the images accurate? At this stage, I would say it varies, sometimes yes, and sometimes no, but the accuracy is improving. I tell my patients not to over scrutinize the details of the computer simulation, but rather to get a “gestalt” or a “rough idea” of how they look with larger breasts. It is not perfect, but it is by far the best way to see how you look with implants. The practice of placing implants into your bra to see how you look is both inaccurate and dangerous in that it can result in severely incorrect information as to what implant you should have. More on this in the web site.
Also in 2009, I developed new technology in surgical instrumentation for breast augmentation. The Epstein Breast Retractors are a set of instruments that in my opinion make the surgery easier for the surgeon and less traumatic for the patient’s tissues. I use them on every case; I don’t know how I lived without them!
My new web site, www.breastimplantslongisland.com is dedicated to topics that relate only to breast augmentation surgery. The core of the web site is a tutorial I call “Breast Implants 101” that uses not only descriptive text but also illustrations that I produced with Kathleen Gebhart, an extremely talented medical artist at the University Medical Center at Stony Brook, NY as well as pulling case material from my vast experience in breast augmentation. The flow of the tutorial would be that of a consultation, but rarely does one have enough time during a consultation to address all these topics in such detail. The beauty of this tutorial is that the patient can go back to it and review any areas they don’t understand or create a list of questions for their surgeon.
I am very proud of this web site and hope that it will be of value to all who visit.
Thursday, April 7th, 2011
Welcome to my blog! Within this regularly updated feature of my website, I will provide visitors with practice news and specials, as well as information regarding the most recent technological advances and new treatments in breast implants.
I believe that patient education and open communication with your doctor are the keys to achieving healthy, fully functional results and patient satisfaction, which is why I strive to provide the highest quality of breast implant care for my patients. This is done by combining technical skill and broad experience with cutting-edge technology for impeccable medical results.
I sincerely appreciate you taking the time to visit my new blog. Please check back often to learn about the latest news, updates and additions to the practice and within the field of breast implants, and feel free to post comments and/or suggestions on any posts that you find of interest.