Breast Augmentation Continued

Breast Augmentation Continued2018-02-02T00:06:58+00:00

Saline or Silicone…How Do I Choose?

Breast implants can serve one or more of a number of purposes; breast cancer victims can use breast implants for reconstructive purposes after mastectomy, or women with asymmetrical breasts may use a single breast implant to balance the difference in size.

Following pregnancy, many women opt for breast implant surgery to correct reductions in breast size, resulting from fluctuating hormones. And of course many breast implant candidates are simply interested in creating a more flattering contour.

Since 1992, silicone gel-filled implants have been available only to breast reconstruction patients and patients undergoing breast revision surgery. In order to receive silicone, women must be enrolled in clinical trials.

It is worth explaining the differences between a silicone gel-filled and a saline-filled breast implant, which is an alternative to the silicone gel implant. The outer shell of both silicone and saline implants is made of a solid silicone material. Solid silicone is widely used in implantable medical devices. In contrast, silicone gel implants are filled with silicone gel, which is a semi-solid. Saline-filled implants are filled with the same kind of salt water that is used in I.V. fluids.

Saline Implants

Offering an alternative to silicone, manufacturers chose saline as an implant filler. Saline implants also have a silicone outer shell (the same shell used in silicone gel-filled implants) and contain salt water.

Saline implants have a silicone rubber shell that is inflated to the desired size with sterile saline. Most implants have a valve that is sealable by the surgeon.

There are two types of saline-filled implants. One type is a fixed volume implant, which is filled with the entire volume of saline at implantation. Another type is an adjustable volume implant, which is filled intraoperatively and has the potential for further postoperative adjustment.

FDA Approval
On May 10, 2000, the FDA granted approval of saline-filled breast implants manufactured by Mentor Corporation and McGhan (Inamed) Medical. To date, all other manufacturers’ saline-filled breast implants are considered investigational.

Silicone Implants

Silicone implants have a silicone rubber shell that is filled with a fixed amount of silicone gel. Silicone implants come in smooth or textured shell surface and vary in shape, profile, volume, shell thickness, and number of shell lumens. Most silicone gel-filled implants are not adjustable which is one disadvantage compared to saline implants.

In the early 1990’s it was reported that silicone breast implants were possibly responsible for connective tissue diseases in some women. Since the controversy began over the potential risks of silicone breast implants, researchers have been conducting scientific studies to investigate the safety of silicone implants.

In 1999, a landmark report, undertaken by the Institute of Medicine (IOM) concluded that silicone implants do not cause major health problems such lupus or rheumatoid arthritis. In fact, there have been a number of major studies failing to find an association between implants and autoimmune diseases or cancer. And while no one can ignore the fact that silicone – and saline – breast implants may cause localized problems for some patients, numerous scientific studies over the years have shown that silicone gel-filled implants are both safe and effective for breast augmentation and reconstruction. However, silicone implants are still not available to the general public in the United States. They are still widely used in Europe and may be available again in the US.

Silicone gel-filled breast implants are available for select cases: women seeking breast reconstruction or revision of an existing breast implant, women who have had breast cancer surgery, a severe injury to the breast, a birth defect that affects the breast, or a medical condition causing a severe breast abnormality.

Silicone-Gel Survey of Plastic Surgeons

Following the advisory panel decision, the American Society for Aesthetic Plastic Surgery sent a survey to 100 of the leading aesthetic plastic surgeons in the United States, and asked them whether they believed the availability of silicone gel-filled breast implants would significantly increase the demand for breast augmentation; more than half (54 percent) of survey respondents said it would not have a significant impact. However, 88 percent of respondents said that being able to choose silicone gel implants would increase breast augmentation patientsatisfaction with the results of surgery.

Saline vs. Silicone: Advantages and Disadvantages

Saline implants, which were officially approved by the FDA in 2000, have some advantages and disadvantages over silicone:

All implants carry a risk of rupture. If a saline implant leaks or breaks inside a woman’s body, the salt water is simply absorbed into her tissue.

The size of saline implants can be altered, depending on the aesthetic or physical needs of an implant recipient. This allows women to increase the size of their implants over time, after her skin has expanded. Or if a woman decides that her implanted breasts are bigger than she wanted, she can minimize their size. Saline implants feature small valves in which a doctor can insert a needle and either add or subtract the liquid. The size of silicone implants cannot be changed without actually changing the implant with an operation.

Some patients may find that saline implants do not offer a natural look and feel and that silicone mimics this more effectively.

However, saline implants carry many of the same risks as silicone gel-filled implants, including capsular contracture, infection, pain, and nerve damage. Implants, whether filled with saline or silicone, are not a lifetime device and may need to be replaced.

Advantages of Silicone Implants
Many surgeons and patients with breast implants have the opinion that silicone implants have a more natural look and feel than saline implants due to the fact that silicone gel has a texture similar to breast tissue.

Advantages of Saline Implants
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 usually 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.

The U.S. Department of Health and Human Services states:

“For some years controversy has existed over silicone implants used for breast augmentation or replacement after mastectomy. Adverse effects from their use have been widely reported in the popular press, with conflicting information often appearing in the medical literature. This controversy and the attendant publicity led the Food and Drug Administration (FDA) first to ban any use of these implants and then to permit limited use, mainly as replacement after mastectomy.

“Silicone is used not only in breast implants but also in implants located literally throughout every part of the body. It has been used: to construct heart valves and other cardiovascular prostheses; to fashion catheters which are used for purposes ranging from drug delivery to cardiac monitoring; in dentistry; in the gastrointestinal tract; as a facilitator for nerve regeneration; in ophthalmology; in the ear, nose, throat, and respiratory tract; as a prosthesis or ingredient in prostheses for many parts of the skeletal system; as a tissue expander; as a cosmetic agent for treatment of scars and wrinkles; in the urogenital tract, including penile prostheses; and in many other applications.”

To access the Breast Implants Patients Surveys 2003: http://www.surgery.org/download/implantsurvey.pdf

Breast Implants: Now

Currently, almost all women in the U.S. undergoing breast augmentation receive saline-filled implants. Approximately 10% of women undergoing breast procedures receivesilicone gel-filled implants, but this is permitted only for breast reconstruction, implant replacement, and severe breast ptosis (sagging). In October 2003, the FDA reviewed new data on silicone gel-filled implants that was derived from ongoing clinical studies and was submitted by implant manufacturers with the hope of winning FDA approval for reintroduction of silicone gel-filled breast implants for general use in breast reconstruction and augmentation. The FDA’s advisory panel recommended reintroduction of silicone gel implants for general use with conditions. The FDA usually follows the recommendations of its advisory panels, but has not yet ruled on the safety and efficacy of silicone gel.

Silicone gel remains a potentially popular implant choice primarily because it produces a natural-feeling breast and is particularly effective for women with minimal breast tissue. Recently, a new formulation of silicone gel, which is thicker than previous gels and retains its shape even in the event of a tear or rupture of the implant shell, has been developed and is undergoing clinical trials. Called “cohesive silicone gel,” this new filler innovation has already been used extensively outside the United States, and eventual FDA approval is anticipated.

The use of sustained mechanical force to induce tissue growth in the breasts has been touted as a method to achieve modest enlargement of the breasts. While some physicians have reported promising results with this technique, others claim widespread failure to achieve satisfactory results with consequent patient disappointment.

What Does the Future Hold?

Some researchers say that new tissue engineering technology using stem cells derived from liposuctioned fat may someday be used to “grow” breast tissue. Or breast enlargement may be achieved through manipulation of hormones or other chemical or biological substances.

These and other innovations are likely to provide increased options for breast augmentation in the 21st Century. In the meantime, women seeking breast enlargement have a variety of choices, and most breast augmentation patients will achieve a high level of satisfaction with the current methods and devices. Surveys consistently show that the overwhelming majority of women who undergo breast augmentation say they would make the same decision again.

The information provided is for general education about breast augmentation, saline and silicone breast implants cosmetic surgery procedures.

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