All breast implants currently in use in the United States, and reviewed by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health and approved by the U.S. FDA, have an outer shell made of medical-grade, biocompatible, solid silicone rubber. These implants are either filled with a sterile saline solution, or those approved strictly for reconstructive purposes may be silicone filled or a combination of silicone-filled with a saline core for tissue expansion. In addition, silicone filled implants are currently in clinical trials and are pending U.S. FDA approval for use in augmentation. Implants vary not only in their composition, but also by size, shape, and other factors. Breast implants are also characterized by:
• The size of the implant, typically measured by the volume of the substance filling the implant
• The projection or profile of the implant, in variations from low to high
• The dimensions of the implant measured by base diameter and projection
• The shell of the implant: smooth or textured, and always of silicone rubber
Silicone-filled implants are always pre-filled. Salinefilled implants may be pre-filled, or filled at the time of placement into a woman’s body. Silicone and saline implants are additionally characterized by the shape of the implants. Some are round and others are contoured with varying degrees in profile. The differences among implants result in more than just an enhancement of breast size. The type of implant used can:
• Enhance overall breast size (width) and projection
• Enhance the projection of a well-rounded, yet flat breast
• Enhance the overall size and width of a small breast with good projection
• Create cleavage
• Reconstruct a proportionate breast to a woman’s body, with a very natural shape and slope
Women’s bodies vary greatly, as do their goals for how breast implants will improve one’s body image. Therefore, it is essential that prior to any breast implant being recommended in your case, your cosmetic surgeon or his or her nurse examine you, take photographs, and possibly take measurements of your current breast profile. In addition, you should be clear on your goals, and define exactly how you wish to see yourself following the placement of breast implants.
If you are considering breast implants and have concerns about latex allergies, you can be confident that the implant shells in use today are latex-free. Inamed offers information specific to latex concerns on their consumer Web site, www.inamed.com. In 1996, the Trilucent implant, filled with purified soybean oil was introduced. In the United States about 200 women received this implant in a U.S. FDAapproved, controlled research study. The study was ended in 1997, due to complications associated with the implant. In June 2000, the Medical Devices Agency (MDA) in the United Kingdom issued a warning entitled Trilucent Breast Implants: Recommendation to Remove, advising women with Trilucent Breast Implants worldwide to have them removed even if they are not experiencing complications. Although not manufactured or marketed by Inamed Corp. or McGahn, Inamed does have information specific to the Trilucent implant on their Web site. Silicone- and saline-filled implants are not the only implants you may hear or read about. Manufacturers and cosmetic surgeons all over the world are testing all sorts of new breast implant fillers. In early 2004, the same researchers who had introduced and tested Trilucent breast implants in 1996 had patented a breast implant filled with polyethelene glycol and saline, and applied to the U.S. FDA to begin using it in clinical trials. In addition, hyaluronic acid-filled implants are in research and development. It is likely that other combinations of substances are under study throughout the world, or currently are being developed.
In most cases, the decision to use an implant that is filled at the time of placement into a woman’s body is based on:
• Surgical method and incision pattern used to place the implant
• A need to adjust implant size to achieve a more uniform result in disproportionate breasts
• Your cosmetic surgeon’s preference
Remember that only saline-filled implants can be filled at the time of surgery to place them. But just as pre-filled implants have a defined size, implants filled at the time of surgery do have a defined range of saline based on the implant size. Implants that are underfilled may result in wrinkling or drooping, and implants that are overfilled may have a distinctly unnatural fullness, be easily palpable (felt by touching with hands) under the breast tissue, and feel much firmer than natural breast tissue. Therefore, it is imperative that you ask your surgeon specifically what type of breast implants he or she will use in your case, about his or her experience with those implants, and the reasons for recommending them to you. Do not confuse an implant filled at time of placement with one that is initially used as a tissue expander. In cases where ample tissue does not exist at the breast mound to cover a breast implant (most commonly in the case of breast reconstruction), a saline-filled breast implant may first serve as a tissue expander. The process of tissue expansion requires the implant to be slowly filled with sterile saline over many weeks and multiple visits to your cosmetic surgeon’s office. Many of these implants have self-sealing valves and, therefore, are left in place once the desired size is reached, or they may be replaced with another type of implant after the tissue expansion process is completed.
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