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The November 17th 2006 Food and Drug Administration’s (FDA) approval of the use of Mentor and Allergan (Inamed Corporation) silicone breast implants in the United States has raised many questions among women in Southern California, especially those in Los Angeles and Beverly Hills.
Prospective Los Angeles breast augmentation patients want to know if they can now receive silicone gel-filled breast implants, and if so, what types of silicone breast implants are available? And what are the potential adverse effects or concerns?
Candidates for Silicone Breast Implants
• Only women of 22 years of age and older can have silicone breast implants for breast augmentation or enlargement.
• Women of all ages can now qualify to have silicone implants for breast reconstruction.
Contraindications for Use of Silicone Breast Implants
Breast implant surgery should not be performed on:
• 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
You should also know that silicone gel-filled breast implants have not been clinically tested on women with:
• Autoimmune diseases such as lupus or scleroderma
• Conditions that could interfere with wound healing and blood clotting
• A weakened immune system (such as women receiving immunosuppressive therapy)
• Reduced blood supply to the breast tissue
• Radiation to the breast following implantation
• Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders (Please discuss any history of mental health disorders prior to surgery) Differences in the Use of Saline & Silicone Breast Implants
Unlike saline breast implants, which are filled with saline after insertion in the body, the silicone breast implants are pre-filled with silicone. Therefore, silicone breast implants, especially the cohesive gel, memory gel, “Gummy Bear,” and the contour profile gel implants, require a larger incision for the insertion of the implant. In fact, the FDA does not allow the use of the periumbilical approach (TUBA) for the insertion of silicone implants, because excessive squeezing or manipulation during insertion can damage the silicone gel-filled breast implants.
What are some of the important factors you should consider when deciding whether or not to get silicone gel-filled breast implants?
• Breast implants do not last forever. If you decide to get breast implants, you will likely need additional surgeries on your breasts over your lifetime due to complications or unsatisfactory cosmetic outcomes.
• Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implants removed and not replaced; your breasts will not change back to the way they looked before your implant surgery. You may have permanent dimpling, puckering, wrinkling, or other cosmetic changes.
• When you have your implants replaced (a revision), your risk of complications increases compared to your primary (first) surgery.
• Routine mammograms to screen for breast cancer will be more difficult with breast implants.
• Breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.
• If your silicone gel-filled breast implant ruptures, it is likely that neither you nor your doctor will know. This is known as a silent rupture. This is why an MRI is recommended at three years after implantation and then every two years thereafter to screen for rupture. However, sometimes there are symptoms. These include hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, and pain, tingling, swelling, numbness, burning, or hardening of the breast.
• Over your lifetime, the cost of MRI screening may exceed the cost of your initial surgery. The MRI screening cost may not be covered by medical insurance.
• All silicone breast implants “bleed” or leak a very minute amount of silicone. However, worldwide studies have not linked silicone bleed to any illness.
What are the different types of silicone breast implants available?
Both Mentor and Allergan manufacture a variety of silicone breast implants. Mentor produces silicone implants of different firmness depending on the degree of silicone cohesiveness. The so-called “gummy bear” implants are the more cohesive silicone gel-filled breast implants made of firmer silicone gel filler to help maintain the shape of the implant.
Potential Complications of Silicone Gel-filled Breast Implants
In the Mentor and Allergan core studies, the most frequent complication was re-operation (additional surgery) – 25-35 percent. Capsular contracture or hardening of the breast implants (13-17 percent) was another frequent complication. Additional common complications include implant removal (7-10 percent), breast pain (7-8 percent), nipple sensation changes (1.5 percent), rupture (2.7- 4 percent), and asymmetry (3-5 percent). The complication rates were typically higher for revision surgery than for primary (first-time) implants.
Decision to Have Silicone Breast Implants
As a plastic surgeon, I often get asked if I would recommend silicone breast implants to my wife. Frankly, many national studies have established the safety of silicone breast implants and have found no link to the development of autoimmune disease, cancer, etc. Nevertheless, there are still unanswered questions about the long-term results (per FDA). Those who choose to have silicone implants enroll in the 10-year, post-approval study so that more light can be shed on the long-term effects of these medical devices.