Breast Implant Efficacy and Safety

What is the shell of currently available breast implants made from?

A silicone elastomer.

What is the material on the inside of currently available breast implants?

1. Saline breast implants are filled at the time of surgery with sterile saline, ideally through a closed filling system.

2. Silicone gel-filled implants come prefilled with a silicone polymer.

What are the advantages and disadvantages of silicone gel-filled breast implants compared to saline breast implants?

Silicone implants are considered to look and feel more natural than saline implants, particularly in women with less breast tissue or in women undergoing breast reconstruction. Because of this, silicone implants can be used in a subglandular position in most patients. However, silicone implants are more expensive and require a larger incision for placement. Owing to current government regulation, silicone implants cannot be used for nonreconstructive purposes in patients younger than 22 years.

What are the advantages and disadvantages of implants with a textured shell?

The textured shell may decrease the rate of capsular contracture but may cause more rippling, have greater palpability, and may be more likely to deflate or rupture.

How do breast implants affect breast visualization by mammograms?

Although breast implants obscure some breast tissue when being visualized by mammograms, particularly implants that are subglandular as opposed to submuscular, the overall rate of breast cancer detection is not affected.

What kind of modification of standard mammography should be done for women with breast implants?

Women with breast implants should have mammograms with Eklund displacement views to visualize the breast tissue adequately.

Eklund views add to the standard craniocaudal (CC) and mediolateral oblique (MLO) views by performing two additional CC and MLO views, and an optional fifth 90-degree lateral view, in which the implant is pushed back against the chest wall and the breast tissue pulled forward. However, the additional views result in more radiation exposure and may increase the risk of implant rupture due to the additional compression.

What are the conclusions of the Institute of Medicine’s report with regard to the toxicology of breast implant material?

On the basis of toxicology studies of silicones and other substances in breast implants, there is no evidence for health concerns.

What are the conclusions of the Institute of Medicine’s report with regard to the surgical complications associated with silicone breast implants?

The reoperations and local and perioperative complications are frequent enough to be a cause for concern and to justify the conclusion that they are the primary safety issue with silicone breast implants. Complications may have risks themselves, such as pain, disfigurement, and serious infection, and they may lead to medical and surgical interventions, such as reoperations, that have risks. An explanation of the risks is an essential element of adequate informed consent for women undergoing breast implantation.

What are the conclusions of the Institute of Medicine’s report with regard to connective tissue diseases associated with silicone breast implants?

On the basis of epidemiological evidence, connective tissue diseases or conditions, neurological diseases or other systemic complaints or conditions are no more common in women with breast implants than in women without implants.

What are the conclusions of the Institute of Medicine’s report regarding the effects of breast implants on breast milk and health effects in children related to maternal breast implants?

There is no evidence of elevated silicone in breast milk or any other substance that would be deleterious to infants. All mothers with implants should attempt breast-feeding.

Based on the conclusions of the Institute of Medicine’s report, what is the evidence for a syndrome or disease associated with silicone implants?

There is no evidence suggesting a new syndrome or disease in women with breast implants.

What is the significance of the National Cancer Institute (NCI) Breast Implant Study?

The NCI study is one of the longest and largest studies on the health effects of silicone gel-filled breast implants and involves 13,500 women with an average follow-up time of 13 years. Unlike other studies that used only the general population as a comparison group, the NCI study compared the health risks of the implant patients to both the general population and the other plastic surgery patients.

Based on the NCI Breast Implant Study, what is the relationship between breast implants and development of breast cancer?

The NCI study found no link between breast cancer risk and any particular type of breast implant. However, there was a shift toward somewhat later detection of breast cancers among the implant patients compared to the controls. Even though the differences were not statistically significant, there were consistently smaller percentages of in situ (early stage) cancers among the implant patients. However, there was no significant difference in breast cancer mortality between implant and comparison patients. This finding has been confirmed by other large epidemiological studies.

Based on the NCI Breast Implant Study, what is the relationship between breast implants and development of nonbreast cancers?