Statement of the American College of Surgeons
to the
General and Plastic Surgery Devices Panel
of the
Medical Devices Advisory Committee
Food and Drug Administration (FDA)
Presented by
Lorraine Tafra, MD, FACS
Director, The Breast Center
Annapolis, MD
Statement on
Pre-Market Approval Application for Silicone Gel-Filled Breast Prostheses
Monday, April 11, 2005
Members of the General and Plastic Surgery Devices Panel, my name is Lorraine Tafra, MD, FACS. I am a breast surgeon practicing in Annapolis, MD, and the director of the Anne Arundel Medical Center Breast Center in Annapolis and the past president of the American Society of Breast Surgeons. I am proud to represent the 66,000 Fellows of the American College of Surgeons and want to thank you for this opportunity to offer a breast surgeon's perspective on the issue of silicone gel-filled breast prostheses for patients who are considering breast reconstruction or augmentation procedures. I am a board certified general surgeon, and would like to state at this time that I have no financial relationship with silicone or implant medical device manufacturers.
Today, I would like to focus my comments on breast reconstruction and augmentation as procedures that improve quality of life for many patients. Reconstruction of a breast that has been removed due to cancer is one of the most rewarding surgical procedures performed by plastic surgeons. New medical techniques and devices have made it possible for surgeons to create a breast that can come close in form and appearance to matching a natural breast. Frequently, reconstruction is possible immediately following breast removal (mastectomy), so the patient wakes up with a breast already in place, having been spared the experience of seeing herself with no breast at all. The availability of breast reconstruction gives the woman an option over which she has some control during a very challenging time of her life.
As a surgeon, I spend a good portion of my time surgically removing breasts. I can tell you the psychological impact of losing an organ that is so visible to oneself and to others, and that is so closely linked to gender identity, is universally negative, no matter what the age. The medical and cosmetic issues of removing this organ are inextricably linked, and returning that organ to a normal appearing state can be crucial. But, no two patients are the same. My patients are old, young, large breasted, and small breasted. After mastectomy some have thick flaps (I'm referring to the thickness of the skin we leave behind) and some have thin flaps. Most patients are asymmetrical...sometimes the cancer side is the smaller size, sometimes it's the larger size. One patient may have as her highest priority, the new breast's appearance: another may only be concerned that it feels like a normal breast. There is no universal reconstruction that works for everyone and the more options we have, the better we can tailor our procedures.
Both breast reconstruction and augmentation provide enormous benefits to women, including an improved self-image and a sense of normalcy. But, as is true with any operation, patients must think carefully about their expectations and discuss them with their surgeon.
The American College of Surgeons has a longstanding commitment to improving the quality of surgical patient care and to enhancing patient safety. Consequently, we look forward to hearing more about the data collected by the manufacturer on the safety of silicone gel-filled breast implants. And, we welcome FDA's review of these new safety data. If these devices prove to be unsafe, we certainly would not support their use in patients. Patient safety is always and will always be the primary concern of the College.
But, we also feel strongly that decisions that effectively limit patient options must be made on the basis of solid scientific evidence. We are concerned that procedures with benefits that are life "enhancing," rather than life saving, are occasionally viewed by many as somehow less important. Breast implants should be regarded as any other medical device that is considered by this panel. Further, distinctions should not be made between their use for reconstruction or augmentation purposes. Why is this device deemed safe for reconstructive patients but not for those seeking augmentation? What message does this send to our breast cancer patients? And, following more than 10 years of clinical studies and trials, if conclusive data are not found showing that these devices pose a significant risk to patients, we believe the choice to use them should be made available to consenting patients.
The College also agrees that it is vital for any woman considering a breast implant procedure to be well informed of all possible risks associated with the procedure, as well as with the device being used. Women must be informed, for example, that breast implants do not last forever, that complications can occur, and that additional operations may be necessary. Consequently, we support this panel's continuing efforts to ensure that breast implant patients have access to comprehensive—and comprehensible—material that can be used in making truly informed decisions about these procedures.
To conclude, let me say again that all surgeons are obliged to be (and the vast majority are) scrupulous in providing their patients with the information they need to give truly informed consent for any operation. We are truly hopeful that the information collected by the manufacturer of these devices will contribute significantly to these efforts, and help to resolve the continuing uncertainty about their safety.
Thank you again for the opportunity to appear here today; I would be happy to answer any questions you have.
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The American College of Surgeons is a voluntary, educational and scientific organization devoted to the ethical and competent practice of surgery, and to enhancing the quality of care provided to surgical patients. For over 90 years, the College has disseminated medical and surgical information to the profession and to the general public, and it has been deeply involved in establishing standards of practice.
Online April 12, 2005
