The New Silicone Breast Implant News

By Elise Brooks, Nip Tuck News Staff Writer
November 27, 2006

After the moratorium in 1992 only patients who met the FDA’s criteria were candidates for Silicone Breast Implants. Some of these patients included women with chest or breast deformities, women undergoing breast lifts, women who already had silicone or saline implants and were having a problem and women who were undergoing reconstructive surgery after breast cancer.

Breast implants are the most studied medical device in the history of medicine. On April 14, 2005, Mentor Corporation, a leading supplier of medical products in the United States and internationally, announced that an advisory panel to the U.S. Food and Drug Administration (FDA) determined that the Company's silicone gel-filled breast implants are safe and effective for use in breast reconstruction and breast augmentation patients. This 7-2 recommendation for approval, with a series of conditions stipulated by the FDA's General and Plastic Surgery Advisory Panel, represented a significant step towards the current FDA’s approval of Mentor's silicone gel-filled breast implants in the United States. Silicone implants are preferred and used regularly in other countries but were under major scrutiny in the USA.

Limited right to choose
On November 17, 2006 the FDA agency announced that Silicone Breast Implants are once again available for cosmetic use in women over the age of 22 in the USA. After years of studies including information from doctors and patients using Silicone breast implants submitted to the IRB (Institutional Review Board) some women now have the right to chose what type of breast implant they feel comfortable putting in their bodies.

However not everyone will have the right to choose between silicone or saline. The FDA still does not allow patients less than 22 years of age to get silicone breast implants for cosmetic enhancement only. The same women are old enough to vote, drive cars, drink alcohol or smoke cigarettes that are proven to cause cancer, but they cannot chose between a saline or silicone breast implants.

Silicone
Saline Breast Implants are encased in a silicone shell. Almost all forms of implants or prosthesis are made of silicone and approved by the FDA. For example, cheek implants, chin implants, calf implants, nasal implants, knee prosthesis, hip prosthesis and testicular implants are all made of Silicone.

Why did it take the FDA 14 years to lift the moratorium on silicone breast implants? When men’s silicone testicular implants went up for the FDA’s OK they were approved in approximately 6 months with no age or physical restrictions qualifying patients.

Men now qualify for silicone breast implants
In the past men could use silicone testicular implants, but they did not meet the FDA’s approval list for silicone breast implants. After November 17th if a patient is a male/transgender patient who is seeking breast enhancement they now can qualify for silicone breast implants. Under the current FDA’s guidelines men now have the option for silicone breast implants if they are over the age of 22.

Some Grey Areas?
There still seems to be some grey areas in the category of who does and who doesn’t qualify under the FDA’s guidelines for silicone breast implants. What if a surgeon has a patient under the age of 22 who has a breast deformity with only one breast and wants both breasts enhanced? Is the surgeon only supposed to put the silicone implant in on the deformed side and a saline implant on the normal side? The rules are not always black or white.

Even surgeons with years of experience are calling the FDA and implant manufactures to ask about the guidelines in some gray areas of who qualifies for silicone breast implants and who does not.

Known for his expertise in breast surgery, Dr. Corbin’s practice also runs the full gamut of plastic and reconstructive surgery, and is not limited to cosmetic surgery. Regarding breast implant procedures, Dr. Corbin does approximately 450 implants per year, of which approximately only 20% involve the use of Silicone Gel implants. The latter category of implants was in the past reserved for patients who met the Adjunct Study Protocol established in l992, which included patients with reconstructive needs, included, without limitation, drooping breasts (ptosis), asymmetry, and patients that require replacement or revision and for whom saline implants were unsuitable (e.g., skin too thin, etc.).

Corbin says if he is in doubt he has called the implant manufacturers experts to advise him if a patient qualifies for silicone or not.

The right to choose
A Stage III invasive Breast cancer patient Lisa, chose silicone breast implants for her breast reconstruction with Dr. Corbin recently. She had the option of silicone or saline implants because she was a reconstructive patient. “I had a mastectomy on my left breast and went through 3 months of Chemotherapy. My hair was gone. My sense of self was forever altered. I was bald. My breast was gone. The loss of a breast is an extremely difficult experience for a woman to go through. Mind, body and spirit do not go unscathed. ” Lisa finds it interesting that a cancer patient whose immune system may be compromised or weaken by cancer can put silicone in her body and a healthy young woman may not qualify for silicone breast implants. “If silicone implants are safe for breast cancer patients why don’t all women have the right to choose them? I absolutely love mine. The new breast Dr. Corbin created for me looks and feels totally natural. I am so glad I had the choice to choose the silicone breast implants.’’

Ruptures
In its Nov. 17 announcement, the FDA recommends that women using silicone implants have their breasts checked by MRI (magnetic resonance imaging) three years after breast augmentation surgery and every two years thereafter for the course of their lifetime. The MRI is recommended to check for any ruptures of the implants. If a leak or break is detected in the prosthesis "the implant should be removed and replaced, if needed," according to the FDA.

With Saline implants ruptures may be more easily detected. Usually if a saline implant has a rupture it goes flat immediately like a tire would if it had a leak. In some cases however, a saline implant can have a slow leak and a deflation can occur over time.

The newer Silicone breast implants are manufactured differently today than they were in 1992. According to Fred Corbin M.D. he along with other experts toured the Mentor manufacturing plant in Texas recently. He saw first hand the care and precision it takes to make a silicone breast implant. According to Dr. Corbin, “The outer case of the silicone breast implants is thicker and provides a protective barrier also the gel substance inside the breast implants is “cohesive”. The new gel is like one solid unit unlike some of the older silicone gel breast implants where the silicone was more like a liquid. If you cut a new silicone breast implant in half it would not drip out of its case. The breast implant would remain as a cohesive unit. Some experts compare to the new silicone gel’s consistency to Jelly candy like a gummy bear. If you cut a gummy bear in half you have 2 separate cohesive pieces like the new silicone breast implants. If a silicone breast implant or saline breast implant ruptures there is no medical science that concludes a ruptured breast implant a danger to a woman’s health.

Safety
The prosthetic devices were pulled from the general marketplace in 1992 because of some concerns that they could rupture and endanger patients and possibly contribute to autoimmune diseases. After 14 years and many studies, no link to health problems was ever proven. According to Carla Peppler a Research Nurse with the Cross Cancer Institute in Canada she was apart of a clinical trial who researched the causes and treatments for breast cancer for over 20 years.” In the data we obtained and studied from my patients and NSABP there was no correlation between breast cancer and silicone breast implants.” In fact, when my daughter came to me before she had a breast augmentation with silicone implants and asked me if I thought they were a health risk I told her not based on any medical evidence I’ve ever seen.”

Beverly Hills plastic surgeon Dr. Corbin says,” I would feel totally comfortable putting silicone breast implants in my wife or daughters. In fact my wife has the new cohesive silicone implants” True to the Hippocratic Oath he took when he became a doctor, Corbin, also states , “I feel silicone breast implants are safe or I would never perform a single surgery using them on any patient knowing that it could harm them.”

Corbin educates his patients on all the risks and the benefits of breast surgery and according to him,” It doesn’t matter to me one way or the other if a patient who is a candidate for silicone chooses saline over silicone. I get beautiful surgery results with both types of breast implants. I inform my patients as much as I can and the ultimate decision I believe should be theirs.”
After the breast implant surgery is over it’s the patient who has to be happy with the implants they chose to live with and enhance their breasts with and not the plastic surgeons, politicians, lawyers, implant manufacturers or the FDA. Women rights have come a long way and all women and men should have the right to choose saline or silicone. The FDA’s recent ruling on silicone breast implants is a step in the right direction.