FDA APPROVAL FOR SILICONE BREAST IMPLANTS

On November 17, 2006, the United States Food and Drug Administration (FDA) approved the use of silicone gel-filled implants. After years of extensive scientific research and sufficient evidence as to the benefits and risks, the FDA is allowing silicone breast implants back on the market. In its recent news release, the FDA states that silicone implants are approved "for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older." (FDA News Release, November 17, 2006)

The approved manufacturers of silicone gel-filled implants are Allergan, Inc. (formerly Inamed Corporation), located in Irvine, California and Mentor Corporation, located in Santa Barbara, California. For many years, Allergan and Mentor have conducted extensive clinical and scientific studies to support the safety of their products, INAMED® Silicone-Filled Breast Implants and MemoryGel™ Silicone Gel-Filled Breast Implants, respectively.

Allergan’s Core Clinical Study, an ongoing safety research program, has collected four years of data involving 715 women who have undergone breast augmentation, reconstruction or revisionary breast surgery. Allergan states, “Silicone gel-filled breast implants are among the most studied medical devices in existence, with thousands of peer-reviewed and published reports on studies, including robust epidemiological studies supporting their safe use.” (Allergan, Inc. Business Wire, November 17, 2006)

Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation says, "Over the past 14 years we have remained devoted to returning MemoryGel™ implants to the U.S. market, and we are pleased to be able to provide women seeking breast augmentation and reconstruction with important new options." (Mentor Corporation Business Wire, November 17, 2006)

The FDA states, its “decision to approve these implants was based on a thorough review of each company’s clinical (core) and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. In addition, FDA conducted inspections of each company’s manufacturing facilities to determine that they comply with FDA’s Good Manufacturing Practices.” (FDA News Release, November 17, 2006)

The two largest plastic surgery membership organizations, The American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS), applaud the FDA’s decision to approve silicone breast implants.

“This is a great day for American women and the plastic surgeons who care for them. Silicone breast implants have been scrutinized more than any medical device, and we applaud the FDA for making its well thought-out decision and allowing American women to make informed choices about their health care,” states the ASPS president, Roxanne Guy, MD. (ASPS Press Release, November 17, 2006)

ASAPS president, James Stuzin, MD, stated, “It is clear that the agency has carefully evaluated the data presented by the manufacturers, as well as the testimony of physicians, patients and advocacy groups and has made a thoughtful decision to give our patients the access to silicone gel breast implants that women in 60 countries around the world have.” (ASAPS News Release, November 17, 2006)

ASPS and ASAPS have joined forces continuing “to offer their assistance to the manufacturers for the conditions set forth by the FDA related to physician and patient education. One comprehensive example of this assistance is a joint web site, breastimplantsafety.org, which offers objective and science based information regarding saline and silicone breast implants.” (ASPS Press Release, November 17, 2006)

THE FDA’s POST-APPROVAL CONDITIONS

The FDA’s approval of silicone breast implants comes with a number of specific and in-depth conditions and requirements. The federal agency requires both implant manufacturers to continue its core study through ten years; conduct a post-approval study of 40,000 women for ten years; develop surgeon device training; research patient labeling and label distribution; continue laboratory studies of device failure; and implement a tracking device to notify patients and surgeons of updated silicone implant information.

The FDA “will continue to gather information about the safety and effectiveness of the implants. Information will be collected about rates of local complications, rates of connective tissue disease and its signs and symptoms, rates of neurological disease and its signs and symptoms, potential effects on offspring of women with breast implants, potential effects on reproduction and lactation, rates of cancer, rates of suicide, potential interference of breast implants with mammography, and MRI compliance and rupture rates.” (FDA News Release, November 17, 2006)

"Allergan welcomes the opportunity to address any outstanding patient concerns related to silicone gel-filled breast implants, and is fully engaged with the FDA to fulfill our commitment to further validate the existing long-term data and science that support the robust safety profile of our breast implant devices," said Patricia Walker, M.D., Executive Vice President, Regulatory Affairs, Research and Development, Allergan Medical, a division of Allergan. (Allergan, Inc. Business Wire, November 17, 2006)

BREAST IMPLANT PROCEDURE

Breast implant surgery enhances the size and shape of a woman’s breast by inserting an implant behind the breast tissue or under the pectoral muscle, pushing the breast tissue forward and making the breast appear fuller. Breast implant surgery has been successful in increasing the overall size of small breasts, balancing uneven breasts, correcting a reduction in breast size after pregnancy and as a reconstructive procedure following mastectomy and other breast surgeries.

The breast implant procedure is usually performed on an outpatient basis in a hospital or plastic surgery center and requires a local anesthetic with sedation or a general anesthetic. For some procedures, especially reconstructive surgeries, an overnight stay in the hospital is required.

The incision position and the implant placement will be determined by the surgeon based on the woman's anatomy, health, desired effects and the method that will produce the best aesthetic result and the least amount of side effects.

Incision Position

Peri-Areolar: A small incision is made where the darker skin of the areola meets the lighter skin of the breast, allowing the scar to blend well with the natural change of the skin color. The surgeon has the greatest degree of precision due to the close proximity to the treatment site. This method can reduce the size of the areola and reposition the nipple. With the peri-areolar method, there is a greater risk of breastfeeding interference and affecting breast and nipple sensation.

Inframammary: The inframammary position is the most common and the least invasive of the three incision positions. The surgeon makes an incision in the crease under the breast, allowing easy access to the breast implant pocket. In some cases, following surgery the fold will drop due to the weight of the new implants and the scar may end up above the breast fold. Healing time with this method is quick and side effects are minimal.

Transaxillary: A popular choice for many patients, the incision is made under the arm. Incisions, generally two to three inches in length, heal well and usually without complications. There is an increased risk of implant damage or misplacement with this method. Shaving and applying deodorant must be avoided for several weeks following surgery.

Implant Placement

Subglandular: In subglandular placement, the implant is inserted over the muscle. For women with a B cup or larger, this is the preferred placement to achieve natural looking breasts. Surgery may be shorter, recovery time is much quicker and swelling is less than with the subpectoral placement method. Also, reoperation is usually more accessible than with subpectoral placement. One drawback to subglandular placement is, in some women, it is easier to see the edges of the implants.

Subpectoral: In subpectoral placement, implants are inserted under the muscle. In many cases, especially very thin women, this results in a more natural breast curve. Subpectoral placement usually results in easier mammogram imaging and less capsular contracture than with subglandular placement. However, subpectoral placement does result in swelling that takes longer to subside and the pain level can be higher than subglandular placement.

According to the American Society of Plastic Surgeons (ASPS), more than 330,000 women underwent breast augmentation surgery in 2005. Approximately 32,000 women requested surgery to repair or replace lost breast mass after mastectomy or lumpectomy surgery. (www.plasticsurgery.org)

SILICONE BREAST IMPLANT OPTIONS

There are many silicone breast implant options: styles, textures, sizes, shapes and profiles.

Silicone breast implants are made from a round or shaped silicone, rubber-like shell and filled with an FDA-approved silicone gel. There are three lumen implant options: 1) a single lumen implant filled with a fixed amount of soft cohesive silicone gel; 2) a double lumen implant with an inner lumen filled with a fixed amount of silicone gel and an outer lumen filled with a fixed amount of saline during surgery; and 3) a double lumen implant with an outer lumen filled with a fixed amount of silicone gel and an inner lumen filled with a variable amount of saline, allowing for adjustments during and after surgery. Implants may have a smooth or textured surface; the latter was designed to reduce the occurrence of capsular contracture.

The size of the implant is determined by the surgeon’s evaluation of the patient’s chest structure, existing breast and skin tissue and personal preference. The larger the desired increase in cup size, the larger the implant, which is measured in cubic centimeters (cc’s). If the existing tissue can not accommodate the size of the implants, the risk of surgical complications may increase, the implants may excessively stretch the skin and be more easily seen or felt through the skin after the surgery and may increase the need for additional surgeries. The shape of the implant is determined by the patient’s preference. Some women prefer a rounded breast appearance, while others prefer a more natural, tear drop contour.

The implant profile, the forward projection from the chest in relationship to the base width of the implant, ranges from low to high projection. The surgeon will determine the implant profile based on the patient’s preference and individual body frame.

SILICONE BREAST IMPLANT CONSIDERATIONS

Ideal Candidate for Silicone Breast Implant Surgery

To be eligible for silicone breast implant surgery, the FDA requires that women are at least 22 years old for breast augmentation or revisionary procedures or any age for breast reconstruction procedures. (FDA News Release, November 17, 2006)

The ideal candidate is in good physical condition, is psychologically stable and has realistic expectations of what can be achieved with silicone breast implant surgery. Women who would like to increase the overall size of small breasts, balance uneven breasts, correct breast size after pregnancy or reconstruct a breast following mastectomy or other breast surgeries can experience excellent results with silicone breast implant surgery.

To ensure the most positive outcome, the ideal candidate takes an active role to:

• Research breast implant and surgery options
• Consider the factors associated with the breast implants and surgery, including the potential risks and complications
• Explore the reasons for breast surgery, making sure the surgery is for her own personal reasons
• Have realistic expectations of breast surgery
• Discuss honestly her personal goals with her surgeon.

Other Considerations for Silicone Breast Implant Surgery

Other considerations regarding silicone breast implant surgery are the health, age and recuperation ability of the patient. Breast implant surgery should not be performed in women with active infection anywhere in their body; women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions; women who are currently pregnant or nursing. (www.mentor4me.com)

At the initial consultation, your surgeon will measure your breasts, assess your breast tissue and skin, review implant options, discuss risks and limitations of procedure options and make recommendations based on your anatomy, medical history and desired results. The surgeon will review your pre-surgery preparation instructions, the procedure process including anesthesia and the expected results as well as post-surgery instructions for maximum recovery. Make sure you discuss all of your questions and specific health issues, especially previous breast surgeries, bleeding tendencies, infections, smoking, alcohol and medications, with your plastic surgeon. Asking questions and communicating your desires with your surgeon are the greatest steps in ensuring optimal results.

Silicone breast implants are not designed to last a lifetime; most patients will need additional surgery to replace or revise their implants and this may occur every ten to twenty years. Many implant surgery changes are irreversible; most patients who choose to remove their implants experience dimpling and other unacceptable permanent cosmetic changes. Implant rupture may occur; regular diagnostic screenings, preferably MRI examinations, are recommended three years after initial surgery and every two years thereafter.

Silicone breast implant surgery may affect milk production and the ability to breastfeed. Mammogram examinations increase risk of rupture due to procedural squeezing and require additional x-ray views, resulting in additional exposure to radiation. It is best to request diagnostic mammography and a radiologist who is experienced with the evaluation of women with breast implants. At-home self-examinations should be performed monthly to check for any irregularities. Health insurance may be affected due to breast implant surgery, therefore it is important to discuss your plans with your insurance company prior to surgery.

SILICONE BREAST IMPLANT PROS AND CONS

Pros
• Patients benefit from enhanced physical contour and fuller appearance
• Improved evenness and symmetry in breast size and positioning
• Restoration of breasts after mastectomy and other breast surgeries
• Silicone breast implants look and feel more natural than other options
• Many silicone implant recipients report increased self-esteem and quality of life

Cons
• Pain, loss of feeling or sensitivity in the nipples or breast tissue; which usually subsides with time
• Implant leakage is hard to detect; regular diagnostic screenings are recommended
• In some cases, capsular contracture may occur when scar tissue around the implant hardens and begins to apply pressure on the implant; additional surgery will be needed to correct
• Implant changes over time; may require additional surgery to replace or revise implants
• Many silicone implant changes are irreversible; candidates should have realistic expectations of surgery

FREQUENTLY ASKED QUESTIONS ABOUT SILICONE BREAST IMPLANTS AND SURGERY

What is the advantage of silicone implants over saline implants?

The decision of whether a patient receives silicone or saline implants is made based upon the patient’s preferences and the surgeon’s evaluation and determination. Recipients of silicone breast implants report more often that their breasts look and feel natural than recipients with saline breast implants.

What is silicone?

Silicone is derived from silicon, a semi-metallic or metal-like element that in nature combines with oxygen to form silicon dioxide, or silica. Beach sand, crystals, and quartz are silica; in fact, silica is the most common substance on earth. Heating silica with carbon at a high temperature can produce silicon. Further processing can convert the silicon into a long chemical chain, or polymer, called silicone – which can be a liquid, gel, or rubbery substance. Various silicones are used in lubricants and oils, as well as in silicone rubber. Silicone can be found in many common household items, such as polishes, suntan and hand lotion, anti-perspirants, soaps, processed foods, waterproof coatings, and chewing gum. The FDA has approved many medical devices made of silicone, including replacement heart valves. (www.breastimplantsafety.org)

Are silicone breast implants safe?

Silicone breast implants are one of the most researched medical devices on the market today. After years of extensive clinical and scientific research, the FDA has approved the use of silicone implants, stating that there was sufficient evidence as to the benefits and risks of the implants. The FDA wants to ensure that a woman’s breasts are fully developed and has set a condition that women must be 22 years of age or older prior to breast augmentation.

What are the major concerns with silicone breast implants?

Silicone breast implants are considered safe for most patients, but there are some concerns that all candidates should research. Rupture is the most common concern for silicone implants and regular screening tests should be performed to detect rupture. If a silent or symptomatic rupture is detected, the implant should be replaced. Although there has been controversial conversations regarding connective tissue diseases associated with silicone breast implants, The Institute of Medicine recently concluded that "Evidence suggests diseases or conditions such as connective tissue diseases, cancer, neurological diseases or other systemic complaints or conditions are no more common in women with breast implants than in women without implants." (www.breastimplantstoday.com)

How do I find a plastic surgeon that specializes in silicone breast implant surgery and is right for me?

Choosing a plastic surgeon is the most important step in the success of your cosmetic or reconstructive surgery. You want a board certified plastic surgeon that has the best skills and silicone breast implant training to help enhance your appearance and achieve your desired results. For a complete picture of silicone breast implant surgery, read the information on this and other sites and make a list of questions. Then find the surgeons in your area and review each surgeon’s qualifications and specialties, education, practice philosophy, articles, before and after photos AND patient testimonials. This information can assist you in making an educated decision in choosing the silicone breast implant surgery option and specialist right for you.

To locate a plastic surgeon in your area, visit www.breastimplants411.com/s_finder.htm.