The improvement in the feel of these implants, as well as the concurrent high failure rate of the saline implants, led to a renewed popularity of the silicone gel implant. These thinner shells, however, ultimately proved less durable than earlier models.
The late s also brought the innovation of subpectoral placement, which improved the CC rate and resulted in a more natural appearance.
By the late s and early s, many women with thinner-shelled, second-generation silicone gel implants were experiencing various complications, including implant failure, CC, and other local problems.
Because of the local complications and concerns about systemic health risk, the Food and Drug Administration FDA called for a brief moratorium on all silicone gel implants, followed by limitations on their cosmetic applications that lasted 14 years. While silicone gel implants were restricted in the US, their placement and development continued virtually unrestrained in most other countries.
By the late s, a third generation of silicone gel implants with stronger shells was introduced. The late s also brought the introduction of textured surface implants, which were developed in an effort to reduce CC rates.
The intent of the textured designs was to mimic the biomechanical effects of the polyurethane cover, without any of its potential negatives. Some refer to a fourth generation of de facto implants being developed coincident with the US FDA moratorium by virtue of refinements in the manufacturing process, which resulted in tighter specifications, lower tolerances for variability, and better quality control.
A fifth generation of implants followed, containing more cohesive or highly cross-linked silicone gel. These models were introduced in Europe in Table 1. 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 By this time, earlier versions of saline implants with high rupture rates had been withdrawn from the market or improved.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. B, D Five months after augmentation with contoured saline implants Allergan LF filled to cc and placed subpectorally. B, D One month after augmentation with round cc silicone implants Allergan style and placed subpectorally. B, D Six months after augmentation with form-stable gel implants Allergan style MM, g placed subpectorally.
B, D Two years after augmentation with smooth, round saline implants Allergan 68MP filled to cc and placed subpectorally from a transaxillary approach. B, D Two months after augmentation with contoured saline implants Allergan LF filled to cc and placed subpectorally. B, D Three months after augmentation with form-stable gel implants Allergan style MM, g placed subpectorally.
Form-stable implants require a larger incision for placement current recommendations are for an incision between 5 and 5. Gel fracture has been found to occur with excessive deformation of an implant resulting from an attempt to place it through a small incision, but it is a rare occurrence, and the effect of a fracture in the gel is largely unknown and likely of little consequence. The increased stability and cohesivity of silicone gel as compared to saline has led to the belief that silicone exerts a more minimal stretching and deforming force on overlying tissue.
As a patient moves, local forces governed by gravity and inertia are exerted on the implant. They found no evidence that breast implant illness existed but recognized that the symptoms of some women were alleviated after removal of their implants.
As a consequence, they required labeling on implants warning about the possibility of getting breast implant illness from breast augmentation. Finally, there is a significant difference in cost between silicone and saline implants.
As mentioned previously, there are different degrees of cohesivity thickness among silicone gel implants and unfortunately as the cohesivity goes up, so does the cost. Although they are saline, Ideal breast implant pricing is more in line with the standard cohesive gel silicone implants. There are many other factors to consider beyond silicone or saline, including the size, type and profile of implants, their position in the chest area on top of the pectoral muscle or partially under the pectoral muscle , and where the incision will be made.
Slack can help you make these decisions by assessing your body shape, lifestyle, and overall goals. Your first step is to schedule a private, cosmetic consultation with Dr. He will discuss your concerns and goals in detail. Patients find Dr. Slack to be the kind of surgeon whose wisdom and compassion make him easy to talk to about the sensitive topic of breast surgery. Contact Dr. Slack today. Our Allen, Texas office is conveniently located 30 minutes north of Dallas and easily accessible from surrounding cities such as Plano, McKinney, and Frisco, Texas.
Office Hours Monday — Thursday: a. Friday: a. This is not the same material as silicon, which is a natural element that has some of the characteristics of a metal and so is called a metalloid. Silicone is man-made. The silicone polymer is made of molecules of silicon, oxygen, carbon, and hydrogen.
It can be liquid, gel-like, or rubbery. Because it can tolerate high heat, silicone is used in kitchenware such as tongs and electrical and thermal insulation. It has a low toxicity and does not react readily with other chemicals, which makes it good for use in plastic surgery and other branches of medicine.
Manufacturers make an implant by dipping a shell or form into a vat of liquid silicone. This is done more than once to develop strong layers. The shell is then cured, stripped from the form, and tested to make sure it is leak-proof. Then, the shell is vulcanized to close it, and a channel in the shell is created to allow the silicone gel to be injected. The channel is then closed, and the implant is cured again.
After a final inspection, the implant is ready to be boxed up and sent to the medical facility. Saline implants are made in much the same way, but the manufacturer can leave the shell empty or pre-fill it. Breast implant shells can be smooth or textured. Because they are filled with liquid or semi-liquid, they are measured in cubic centimeters, or ccs.
Generally, they range from 80 to ccs, with a one to one and a half increase in cup size represented by to ccs. Some people may be nervous of silicone implants because they were withdrawn for being unsafe several years ago. But a new type of silicone implant, introduced in , is now on the market and deemed to be safe. Silicone implants are useful for women who want breast augmentation but do not have a lot of breast tissue. Silicone implants tend to make the resulting breasts look more natural.
They also give the breasts a more natural feel. The patient might not even know that her implant has ruptured unless she has pain or notices her breast looks different. Indeed, the only way to really find a rupture of a silicone breast implant is through imaging technology such as an MRI.
Saline implants are filled with sterilized salt water. One advantage that they have over silicone implants is that they can be placed while they are empty and filled later.
This lets the surgeon control the volume of saline solution until the breasts are symmetrical and the right size. Even if the opening is under the arm, around the nipple, or along the curve under the breast, the scarring left behind tends to be minimal.
Women who opt for a saline implant need to have a fair amount of breast tissue. If they do not have a sufficient amount of breast tissue, they may see rippling around the outer edge of the breast after the implant has been inserted.
If they do burst, which is unusual, the body simply absorbs the saline while the implant deflates.
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