The IDEAL IMPLANT is an improved saline implant that uses no new materials, fillers or manufacturing processes. It is made from only saline implant shells, valves and patches, with saline as the only filler material. And, it is manufactured entirely in the United States.
The IDEAL IMPLANT has a novel, yet simple design, consisting of a series of saline implant shells of increasing size nested together. There is an inner shell defining an inner saline compartment and an outer shell defining an outer saline compartment; between these shells are one to three unattached, perforated shells. This internal structure is designed in an effort to control movement of the saline filler. The goal is to reduce the bouncing associated with standard saline implants and to give the natural, breast tissue-like feel associated with silicone gel implants.
The engineered structure of the IDEAL IMPLANT appears to provide internal support, so when it is held upright, the upper portion of the implant does not collapse the way a standard saline implant does. In addition, the internal structure seems to provide support to the edge of the outer shell to minimize wrinkles and folds, even at the minimum fill volume. Since shell folds are thought to be a major cause of implant deflation, support of the edge to reduce folds, if found to occur in clinical use, may result in a lower deflation rate for the IDEAL IMPLANT than for the standard saline implant.
The shell geometry of the IDEAL IMPLANT is designed to be similar to the silicone gel implant. It conforms to a convex surface, such as the chest wall, so the implant edge lies low and close to the surface. This low position of the edge has the potential to minimize wrinkling on the sides, as is the case with the silicone gel implant.
The IDEAL IMPLANT requires a relatively small incision since it is inserted empty and then each lumen filled with saline through self-sealing valves. It was designed to allow for sub-muscular or sub-glandular position with standard surgical techniques. It is available in the fourteen most popular sizes.
If the IDEAL IMPLANT ruptures, detection will be obvious on physical examination since the implant deflates and the saline is absorbed by the body. In many cases, replacement may be possible under a local anesthetic, rather than the general anesthetic needed for replacement of a silicone gel implant.
The key feature of the standard silicone gel-filled implant is that it feels somewhat like breast tissue. It requires a somewhat larger incision because it is filled when manufactured and can be damaged if forced through a small incision.
Compared to a standard saline implant, it collapses less when held upright, shows less wrinkling on the sides and is slightly under-filled. It has shell geometry that conforms to a convex surface, such as the chest wall. The implant edge lies low and close to the convex surface.
Even with the recent FDA approval of the standard silicone gel implant, many women in the US regard it as a “tainted” product and remain concerned about safety issues such as difficulty detecting a rupture, requiring an MRI scan, diffusion of small silicone compounds into the tissues and the possible long-term effects of silicone.
The standard silicone gel implant did not receive a “clean bill of health” from FDA when approved in November 2006. A number of safety issues of concern are listed in the FDA mandated Patient Information Brochure that women must read and sign prior to receiving a silicone gel implant. Prominent is the explanation that ruptures of the implant are usually “silent” and undetectable by physical examination. Detection of implant rupture requires an MRI scan of the breasts at a cost of approximately $2000. The importance of monitoring a silicone gel implant for silent rupture, and removal if rupture is detected, usually under general anesthesia, is emphasized.
The FDA-mandated Brochure notes that at 2 years, 10% of women with a ruptured implant have silicone gel move from inside the scar capsule to the surrounding tissues. This is probably the basis for the FDA monitoring recommendation to women and surgeons that an MRI scan be done at 3 years post-operatively and then every 2 years for life. In addition, an MRI scan is indicated when there are signs of possible rupture such as pain, a lump and capsule contracture.
The Brochure states that there is “the possibility of risks, yet unknown, which in the future could be determined to be associated” with a silicone gel implant. Though connective tissue disease is unlikely associated with an intact implant, there is no valid study to rule out a possible association with a ruptured implant. Another issue is diffusion (bleed) of small silicone compounds into the tissues. While less than 1% of these compounds diffuse through an intact implant shell and are of no clinical significance, it is not known how much diffuses into the tissues through a ruptured implant shell and if this is of any clinical significance.
The standard saline-filled implant is just a water balloon that does not have the natural feel of breast tissue. It requires a relatively small incision since it is inserted empty and then filled with saline through a self-sealing valve. To keep it from sloshing and bouncing, it usually is placed under the chest muscles. Since it has no internal structure, the upper portion collapses when held upright.
The shell geometry of the standard saline-filled implant does not conform well to a convex surface, such as the chest wall. As a result, the implant edge is raised above the convex surface, a situation made worse by the common practice of over-filling with saline in an attempt to reduce wrinkling. This elevated implant edge, when pushed down by the overlying soft tissue, may result in the wrinkling on the sides often seen with a standard saline implant.
If a saline implant ruptures, the implant deflates and the saline is absorbed by the body over a few days. Detection of a rupture is obvious and replacement can be done under a local anesthetic in many cases.
The IDEAL IMPLANT is for investigational use only.