BREAST IMPLANT OPTIONS
FDA APPROVAL OF SALINE-FILLED BREAST IMPLANTS
Silicone gel-filled breast implants were invented in 1963. Saline-filled breast implants were invented in 1969. At that time, the FDA was only responsible for regulating drugs, and the number of medical devices available was so limited that no one felt federal regulation of them was necessary. In 1976, Congress passed the Medical Device Amendments to the Food and Drug Act, expanding the FDA's authority and responsibility to include regulation of medical devices, such as breast implants, which were already on the market. Congress did not provide the FDA with any additional funding to support this new set of responsibilities, however. The agency therefore placed most devices (including breast implants) in class II, requiring general controls and performance standards, but no detailed studies. This situation continued until 1981, when a clever attorney in San Francisco successfully sued Dow Corning on behalf of a patient with rheumatoid arthritis. The attorney had read the part of the Medical Device Amendments that states that devices must be proved safe and effective before being released for use. This wording places the burden of proof entirely on the manufacturer, if a patient develops a problem and alleges that the device created that problem. Since no one knows what causes rheumatoid arthritis, the manufacturer couldn't prove that the breast implant DIDN'T cause it. The patient won the case--for 3 million dollars. The six men and women on that San Francisco civil federal jury didn't have any medical training, and didn't base their decision on any scientific studies. They just decided that, in this particular case, the manufacturer couldn't prove that the implants DIDN'T cause the woman's rheumatoid arthritis. Since this was the first case addressing the issue, however, it became the law of the land that breast implants cause rheumatoid arthritis. On January 19, 1982, the FDA responded by proposing to place breast implants in class III, requiring stringent testing. In 1988, after Dow Corning had lost several more lawsuits, the FDA finally did reclassify breast implants into class III. In 1992, the FDA placed silicone gel-filled implants under restriction, for research use only, and left saline-filled implants on the market in the same "not approved but also not restricted" status that had been the case ever since 1976. In 1994, the FDA met with manufacturers to set the ground rules for pre-market approval testing of saline-filled breast implants. In March 2000, the implant manufacturers completed their 5 year pre-market approval studies and submitted the data to the FDA. On May 10, 2000, the FDA approved saline-filled breast implants for general use.
FDA APPROVAL OF SILICONE GEL-FILLED BREAST IMPLANTS
In 1992, the FDA placed silicone gel-filled breast implants under restriction, for research use only. Research studies were initiated for women who had had a mastectomy for cancer, for women who already had silicone gel-filled implants from a previous procedure, for women who needed a breast lift, and for women who had previously had problems with saline-filled implants. In 1997, Congress approved funding for the Institute of Medicine of The National Academy of Sciences to conduct an independent, unbiased review of all past and ongoing scientific research regarding the safety of silicone breast implants. After reviewing literally every scientific study ever published regarding silicone gel-filled breast implants, the Institute identified 17 studies that were of sufficient quality that they could be trusted. These high quality studies had age-matched control groups of women without implants, so the occurrence of diseases in women with implants could be compared to the incidence of those same diseases in women their same age, who did not have implants. They had a large enough study population that a statistically valid conclusion could be drawn, and they had been conducted in a careful scientific manner. On June 15, 1999, the Institute of Medicine published their findings: "A review of 17 epidemiologic reports of connective tissue disease in women with breast implants was remarkable for the consistency in finding no elevated risks or odds ratio for an association of implants with disease." Although women with implants do sometimes develop connective tissue diseases, it has turned out that those diseases do not occur more frequently in women with implants than in women without implants. I am a clinical investigator for both McGhan and Mentor silicone gel-filled breast implants. Those studies are no longer enrolling new patients, but I continue to follow patients for their 3yr, 5yr and 10yr checkups. In November, 2006, the FDA eased the restrictions on silicone gel implants, and made them once again available for general use in breast augmentation, with conditions: the patient has to be at least 22 years old, and agree to participate in a post - approval study with followup exams at 1 year, 3 years, 5 years and 10 years. MRI examinations to check for silent rupture are recommended at three years, and every two years after that. The advantages of the silicone gel-filled implants are that they feel more natural to touch than saline-filled implants, and don't show visible rippling at the edge of the implants. This is particularly advantageous if the implants are placed above muscle, in the "sub glandular" position. The disadvantages of the silicone gel-filled implants are that they add $1000 to the cost of your procedure, and require you to participate in the post-approval study protocol for 10 years after the implants are placed.
IMPLANT MANUFACTURERS
In May 2000, the FDA approved two American companies, McGhan Medical and Mentor Corporation, to produce saline-filled breast implants for cosmetic breast enhancement. Both companies manufacture implants in several styles, offering round and contoured shapes, and smooth and textured surfaces. Following a series of corporate mergers, McGhan Medical is now part of Allergan.
IMPLANT MANUFACTURERS' GUARANTEE
ALLERGAN IMPLANT WARRANTY: Standard warranty (Included with all implants, no extra charges or paperwork) 1. Lifetime free replacement implant, if original implant fails. 2. The replacement implant can be any size or style. It can be different from the implant it is replacing, if you like. 3. If rupture occurs in the first ten years after the implant was placed, Allergan will pay up to $1200.00 to help cover the cost of the surgery to replace the implant. Extended warranty (Requires submission of a registration form and payment of $100 to Allergan within 1 month of breast augmentation surgery.) 1. Lifetime free replacement implant, if original implant fails. 2. The replacement implant can be any size or style. It can be different from the implant it is replacing, if you like. If you would like to replace both implants at the time one of them fails, Allergan will provide 2 free implants. If the style you select costs more than the style you are replacing, you will be liable for the difference in price between the two styles of implant 3. If rupture occurs in the first ten years after the implant was placed, Allergan will pay up to $2400.00 to help cover the cost of the surgery to replace the implant.
MENTOR IMPLANT WARRANTY: Standard warranty (Included with all implants, no extra charges or paperwork) 1. Lifetime free replacement implant, if original implant fails. 2. The replacement implant will be the same or similar type as the original implant. 3. If rupture occurs in the first five years after the implant was placed, Mentor will pay up to $1200.00 to help cover the cost of the surgery to replace the implant. This warranty covers implant deflation due to crease fold failure, patient trauma, or unknown cause. It specifically does NOT cover removal of intact implants due to capsular contracture, wrinkling or rippling. It further does NOT cover implant damage during reoperative procedures, open capsulotomy, or closed compression capsulotomy. Extended warranty (Requires submission of a registration form and payment of $125 to Mentor within 1 month of breast augmentation surgery.) 1. Lifetime free replacement implant, if original implant fails. 2. The replacement implant will be the same or similar type as the original implant. 3. If rupture occurs in the first ten years after the implant was placed, Mentor will pay up to $1200.00 to help cover the cost of hospital and anesthesia charges, and up to $1000 to help cover surgeon's fees for the surgery to replace the implant. This warranty covers implant deflation due to valve failure, crease fold failure, patient trauma, or unknown cause. It specifically does NOT cover removal of intact implants due to capsular contracture, wrinkling or rippling. It further does NOT cover implant damage during reoperative procedures, open capsulotomy, or closed compression capsulotomy.
IMPLANT FILLING MATERIAL
Normal saline solution is distilled water with 0.9% salt added, to exactly match the salt concentration of your natural body fluids. Everyone's natural body composition is 71% normal saline. If a saline-filled implant should wear out someday and begin to leak, the normal saline solution that leaks out will be immediately absorbed into the circulation and cleared by the kidneys, with no harm to your body.
Silicone is a polymer made by hooking together several individual silicone molecules to form a chain. The physical characteristics of the polymer change, depending on the length of the chain. Short-chain silicone polymers are oils, slightly longer chain silicone polymers are gels, still longer chain silicone polymers are rubbery in consistency, and longest chain silicone polymers are solid plastics. Silicone, the core atom in the silicone molecule, has many chemical characteristics similar to carbon, which is the core atom for all biological molecules. This chemical similarity is believed to be the reason for silicone's biological compatibility. Silicone is the benchmark substance for biologic nonreactivity in the US Pharmacopeia. Stainless steel, polyethylene, polycarbonate and all the other substances used in implantable devices (heart valves, artificial joints, etc.) are all rated in comparison to silicone.
IMPLANT SHELL
The implant filling material is contained within an envelope, or "shell," made of silicone rubber. Another word for silicone rubber is "elastomer." The room-temperature vulcanizing process for creating a smooth-surface, silicone-rubber elastomer for saline-filled implants was developed in 1969. In 1979, the manufacturer changed the design of the filling valve to its present form. In 1986, surface texturing became an available option. The theory behind surface texturing was that the textured surface would prevent capsule contracture. This has proven to be partly true if implants are placed in the subglandular position, but has been shown to not make any difference if implants are placed in the submuscular position. The two advantages smooth implants have over textured implants are that they are thinner-walled and more flexible (therefore less likely to be detectable by touch,) and they cost less. The elastomer shell of the Mentor implants is somewhat thinner and more flexible than the elastomer shell of the McGhan implants. At 3 years follow-up, 79% of patients with each kind of implant had good cosmetic results, natural in both appearance and feel. Among the 21% for whom the implants had a cosmetic imperfection, Mentor implants had a higher incidence of visible wrinkling, and Allergan implants had a higher incidence of being detectable by touch. (This is for saline implants. Gel implants are much less likely to cause visible rippling or feel abnormal to touch.)
IMPLANT SHAPE: ROUND VS CONTOURED
Contoured implants are wider than they are tall, and project forward in front of the chest wall farther than similar-sized round implants. Since they are not round, they look strange if they get tilted or rotated. To help keep them fixed in place, they have textured surfaces. Since they don't move, we don't do softness exercises on them. I use them frequently for breast reconstruction after a mastectomy, and occasionally for above-muscle breast augmentation in female body builders. I use round implants for most breast augmentation. I almost always use smooth-surfaced implants for augmentation, because they feel more natural to touch than textured-surface implants.
IMPLANT SIZE
Information is available from several sources to help you select your implant size. Photos: Internet photos from breast augmentation websites can be helpful, especially if information is included about the ribcage size of the person in the photo. (Try www.implantinfo.com). Photos from men's magazines can be helpful as a demonstration of a desired postoperative look, but selecting the implant that will take you from your starting ribcage size and starting breast shape to the postoperative appearance of the model in the photo requires long experience, good judgment and a certain amount of luck on the part of your surgeon. Trying on bras and implants: If you will wear a knit top to your office consultation, we can fit you with a bra in your desired postoperative size, then try different sizes of implants to see which size fills out the bra. You can then put your knit top on to see how you look in the mirror with that size bra and implants.
ANESTHESIA
Local anesthetic is always injected into the operative site before the operation. It helps separate the tissue, making the surgery easier to perform. It also causes the constriction of blood vessels, which reduces the amount of bleeding during surgery. To minimize your awareness of the surgery, your local anesthetic will be supplemented, either with sedative medications given through your IV, or general anesthesia.