Silicone or saline which is better 2010

Silicone gel and saline breast implants were already in use in the US when Congress empowered the FDA to regulate medical devices in In , the FDA required that all currently-marketed saline implants be formally evaluated and approved. By this time, earlier versions of saline implants with high rupture rates had been withdrawn from the market or improved.

The manufacture of the silicone elastomer shell had evolved several times, including improving the fill valves and switching from a platinum-cured formulation to the current, more durable room-temperature vulcanized RTV model.

Both Inamed now Allergan and Mentor saline implants were formally approved in Saline implants were never under a cloud of controversy to the same degree as silicone gel implants, but they also have not yielded the same innovations.

In terms of changes and improvements, several shaped saline implants were introduced around the same time as the shaped gel implants in , and they remain useful options for patients choosing a saline implant. The choice of an implant for breast augmentation has implications for both the patient and surgeon. To better analyze the multiple factors that influence implant choice, we examine the issue from a various points of view, including the perspective of both patient and surgeon.

Some considerations that enter into the decision process are the look and feel of the implant, the expense both initial and maintenance , and the safety and complication rates associated with the implant. As an analogy to the saline versus silicone choice, we often compare the implants to cars.

The saline implant is like a Volvo, a car developed and marketed as the gold standard of safety, whereas the silicone gel implant is like a BMW, a car designed and marketed as the gold standard of performance. They are both excellent cars, just as saline and silicone gel are both excellent implant choices. Both implants are safe and both perform well, but there are differences.

Although silicone gel offers some aspects of better performance namely a look and feel that more closely mimics natural breast tissue , saline implants sidestep all concerns over rupture and gel exposure. With this in mind, patients seem better able to grasp both the safety and performance differences between the two choices and make an informed decision based on which elements are most important to them.

Patients seeking breast augmentation are almost always concerned about costs. The retail cost of silicone gel breast implants is roughly twice that of saline implants. Depending on which aspects of the implant are most important to the individual patient, this cost may prove significant. Further costs associated with implant surveillance are also higher for silicone, as routine office visits and possibly diagnostic testing are required to evaluate implant integrity in the long term.

In its approval of silicone implants, the FDA required the manufacturer, in its labeling literature, to recommend follow-up magnetic resonance imaging MRI at three years postoperatively and then every two years thereafter.

Each patient is also required to sign an informed consent for silicone gel implants, acknowledging this recommendation. Many patients seem to feel that this represents an excessive burden, especially as insurance will likely not cover the cost of these tests. These recommendations represent an increased time and financial investment in the long term.

Furthermore, even if patients are not required to pay out of pocket for follow-up physician visits, those visits have the practical effect of costing physicians revenue-earning time.

We will explore this potential cost to physicians in a later section. Although saline implants have fewer surveillance needs because their failure is obvious , they appear to have a slightly higher rupture rate and may represent an increased likelihood of early replacement in a small percentage of patients Tables 2 and 3.

Data are for Soft Touch, a registered trademark of Allergan, Inc. Soft Touch implants are not yet available in the US. Although numerous studies have shown no increase in connective tissue disease associated with silicone gel implant rupture, some women are still fearful of silicone gel implants.

There are some realistic risks to silicone gel rupture—namely, that silicone gel will leak outside the breast capsule and enter the local tissue. In microscopic amounts, this silicone is believed to be innocuous.

In larger amounts, the silicone can potentially result in a palpable mass. In either case, this finding has been exceedingly rare recently and only isolated cases have been reported.

These findings can be disconcerting but have not been shown to cause any systemic symptoms or diseases. Saline implants remain the gold standard of safety, as they eliminate any silicone gel exposure concerns. Their rupture is completely harmless and this represents peace of mind for some women.

Because of the harmless and obvious nature of device rupture in these cases, saline implants require a much less rigorous consent process. Both silicone gel and saline breast implant patients have been studied to determine whether implants present a risk for breast or other cancers, difficulty in breastfeeding, exposure to platinum, and adverse effects in offspring. None of these risks has been shown to be increased in women with either type of breast implant.

Gel implants, when compared to saline products by the same manufacturer, have been shown in core studies to have lower rates of rupture, malposition, and asymmetry than their saline counterparts. CC rates were found to be nearly equal at three years, as were reoperation rates in both the silicone gel and saline groups. CC at more than five years seems to be slightly more common with the silicone gel implant Tables 2 and 3. Data collected on form-stable implants in limited use in the US but in wide use worldwide suggest that they outperform round implants in every category Table 4.

US data collected by Allergan and Canadian usage data collected by Mentor seem to indicate that both the Allergan Style and the Mentor Contour Profile Gel CPG implants have superior performance and safety data as compared to the current round silicone gel and saline implants. As implant-based breast reconstruction and augmentation have grown in popularity, the choices available to the plastic surgeon have also increased.

Beginning with saline implants, there is a choice of seven different types. These include moderate-, moderate plus-, or high-profile round implants moderate profile implants with smooth or textured surfaces are available from both Mentor and Allergan , as well as anatomic implants in moderate height, full height, and full height with full projection Mentor Contour Moderate and High Profile or Allergan styles , , and This is in contrast to the much larger and more varied array of silicone gel implants.

Even in the US, where silicone implant availability is restricted as compared to Europe, the implant choices are still more diverse. Allergan offers five options for round implants in low, medium, medium-high, high, and extra projection with some available in both smooth and textured surface.

Mentor offers a similar lineup, with three options in terms of projection also with some in either smooth or textured surface. Add to this the many options not yet available in the US, and the possibilities grow even further. In addition, several implant manufacturers offer varieties of adjustable implants that allow expansion with an inner saline reservoir while maintaining the feel and shape of a silicone gel implant with an outer gel layer.

Style highly cohesive silicone breast implant core study results at 3 years. Plast Reconstr Surg ; 7 SS. Soft Touch is a registered trademark of Allergan, Inc. Style cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation.

Plast Reconstr Surg ; Although silicone gel breast implants have been controversial at times, the advantages of their natural weight and feel, as well as their ability to be molded and shaped, have outweighed concerns over past problems and kept them at the top of the implant market.

Round silicone gel implants have always had a more breast-like consistency than saline and have better resisted visible or palpable rippling in patients with a thin tissue envelope. With form-stable implants, surgeons will have a much more powerful tool to help patients with small breasts and thinner skin envelopes achieve a natural result. Note the rounded look of both the round saline and silicone gel implants compared to the more natural look of the contoured saline and the form-stable silicone gel implants.

For patients who desire a less round look, the form-stable implant is an option. A, C A year-old woman who presented for breast augmentation. B, D Three months after augmentation with smooth, round saline implants Allergan 68MP filled to cc and placed subpectorally from a transaxillary approach. Currently, saline breast implants are FDA-approved for patients 18 and up. Silicone gel implants come pre-filled to the correct volume with a cohesive gel material. This is less likely to lose its shape and have the silicone migrate outside the implant, but the implants cannot have their size adjusted.

Silicone gel implants feel the most similar to natural breast tissue of all options, and help to create a nice, full breast. Silicone is a synthetic polymer known for its stability, durability, and versatility. Silicone can be formed into consistencies ranging from a thin liquid found in machine lubricants to a very hard plastic such as that used in heat-resistant cookware.

The consistency of silicone is achieved through a process called cross-linking. Silicone with lower cross-linking will be softer, while higher cross-linking creates more bonds between the silicone particles, resulting in a firmer consistency. This silicone consistency can best be compared to that of Jell-O. Newer highly cohesive silicone gel implants have enhanced cross-linking in their structure, resulting in a firmer gel consistency that is a little firmer and better suited for use in contoured implants.

While technically both used silicone gel, the highly-cohesive shaped options are different enough in look and feel that we tend to talk about them as a separate implant type altogether. Make an Educated Decision Before deciding on the details of your breast implant treatment, speak with a knowledgeable doctor who can help you achieve the results you want. Popular Tags. All Posts by Month. Stephen P. Hardy, M. Locations We have 2 locations in MT.

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Cordeiro and Andrea L. Patient satisfaction with postmastectomy breast reconstruction A comparison of saline and silicone implants. ScienceDaily, 8 November Breast cancer patients prefer silicone over saline implants after mastectomy.

Retrieved November 9, from www. The way women generally approach big decisions, combined A random phone survey of 1, Print Email Share.