Saline Implants Saline implants have a silicone rubber shell that is inflated to the desired size with sterile saline. The implants are placed under the pectoralis muscle deflated and therefore, the incision used for this type of implant is minimal. These implants can be overfilled to achieve a more rounded appearance. The FDA has approved the saline breast implants for breast augmentation / breast reconstruction surgery for all patients: Approval On May 10, 2000, the FDA granted approval of saline-filled breast implants manufactured by Mentor Corporation and McGhan Medical. To date, all other manufacturers’ saline-filled breast implants are considered investigational. Saline implants have some advantages over silicone implants. Silicone implant ruptures are harder to detect. When saline implants rupture, they deflate and the results are seen almost immediately. When silicone implants rupture, the breast often looks and feels the same because the silicone gel may leak into surrounding areas of the breast without a visible difference. Patients may need an MRI to diagnose a silicone gel rupture. Saline implants are also less expensive than the silicone gel implants. Silicone Implants Silicone implants have a silicone rubber shell that is filled with a fixed amount of silicone gel. Most silicone gel-filled implants are not adjustable and therefore, the incision used to place the silicone gel implant is larger than the incision needed for saline implants. The silicone gel implant cannot be overfilled – it comes in an exact size that cannot be manipulated. Silicone implants vary in shell surface (smooth/textured), shape, profile, volume, shell thickness, and number of shell lumens. Some surgeons feel that silicone implants have a more natural look and feel than saline implants because silicone gel has a texture that is similar to breast tissue. Each patient differs in the amount of breast tissue that they have. If a patient has enough breast tissue to cover the implant, the final result will be similar when comparing saline implants versus silicone gel implants. If a patient has very low body fat and/or very little breast tissue, the silicone gel implants may provide a more natural result. As of 2006, the FDA has approved the use of silicone gel implants manufactured by the Mentor Corporation and Allergan (formerly McGhan) for breast augmentation surgery for patients over the age of 22. Plastic Surgery Societies Applaud the FDA’s Decision to Approve Silicone Breast Implants For Immediate Release: November 17, 2006 Arlington Heights, Ill. (November 17, 2006) – The American Society for Aesthetic Plastic Surgery and The American Society of Plastic Surgeons, the two largest plastic surgery membership organizations, applaud the FDA’s decision today to approve (manufacturer’s) silicone breast implants and return these devices to the U.S. market. This decision comes 14 years after the FDA restricted access to the silicone implants because of safety concerns. “This is a great day for American women and the plastic surgeons who care for them,” said Roxanne Guy, MD, ASPS president. “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.” Today’s FDA decision follows a lengthy process in which the agency sent “approvable with conditions” letters to the two silicone breast implant manufacturers in the second half of 2005. The approvable letter stipulated a number of conditions that the manufacturers needed to satisfy in order to receive FDA final approval to market and sell silicone breast implants in the United States. These letters came after an FDA advisory panel hearing in April 2005, in which the panel heard more than 20 hours of data presentations from the manufacturers and public comment. Approximately 300,000 women chose breast augmentation in 2005, according to ASAPS and ASPS statistics. Nearly 58,000 women had breast reconstruction in 2005, according to ASPS. Both breast augmentation and reconstruction have been proven in numerous studies to have psychological and physical benefits for women who choose these procedures. The ASPS and ASAPS will continue 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. The American Society for Aesthetic Plastic Surgery (ASAPS) is the leading organization of board-certified plastic surgeons specializing in cosmetic plastic surgery. ASAPS active-member plastic surgeons are certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada. www.surgery.org . The American Society of Plastic Surgeons is the largest organization of board-certified plastic surgeons in the world. With more than 6,000 members, the Society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. ASPS comprises more than 90 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the Society represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada. Pros and Cons of Each Both saline and silicone breast implant fillers have pros and cons that must be weighed when making your decision. An advantage of saline breast implants is that, if ruptured, the saline (salt solution) is absorbed by the body. In contrast, silicone gel may stay inside the implant shell or leak outside of the shell if it ruptures. If a saline breast implant ruptures it is noticeable, because the implant deflates. This is not necessarily the case with silicone breast implants. Sometimes there are no obvious symptoms when a silicone-gel implant ruptures. This problem, referred to as “silent rupture”, was one of the concerns expressed by the FDA. As a result, the FDA recommends that women with silicone-gel filled implants must undergo magnetic resonance imaging (MRI) three years postoperatively, then every two years to check for ruptures. These imaging exams should start three years after your breast implant surgery. Silicone implants must be removed if they rupture. Other differences involve how the breast implants are filled. Saline implants are filled after they’re implanted, so saline implants require a smaller incision than prefilled silicone breast implants. Also, many saline implants can be adjusted after surgery. The doctor can use a syringe to put in more liquid or take it out. The size of standard pre-filled silicone implants cannot be changed. Today’s silicone gel-filled implants can be placed in any of the various implant placement positions:
- subglandular (over the muscle)
- partial submuscular (the top 2/3 is covered by the muscle)
- complete submuscular (under the muscle)
Saline implants, due to their greater tendency for rippling and wrinkling, most frequently are placed in the submuscular position.