Breast Implant Efficacy board

Question 1

discuss the breast implant safety?

Answer 1

Disclaimer: The controversy regarding breast implants, particularly silicone gel-filled implants, continues to be debated despite many large studies that have failed to show a significant systemic health risk in women who have these devices. This is partially due to small and poorly designed reports that made associations between breast implants and various systemic diseases. As such, the questions and answers in this chapter are based on large well-designed studies, pooled data, and consensus statements by established health organizations. It should be understood that in some cases, there may be contradictory opinions in the scientific literature. Unless otherwise noted, these questions apply to saline or silicone gel-filled breast implants available without restrictions in the United States in 2010.

Question 2

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

Answer 2

A silicone elastomer

Question 3

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

Answer 3

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

Question 4

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

Answer 4

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 non-reconstructive purposes in patients younger than 22 years

Question 5

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

Answer 5

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

Question 6

How do breast implants affect breast visualization by mammograms?

Answer 6

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.

Question 7

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

Answer 7

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◦ 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

Question 8

discuss safety of Silicone Breast Implants, in 1999

Answer 8

During the 1990s, there was concern about the safety of silicone gel-filled breast implants. Because of this, and in response to federal government legislation, the US Institute of Medicine conducted an exhaustive review of available data on breast implants and issued its report, Safety of Silicone Breast Implants, in 1999

Question 9

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

Answer 9

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

Question 10

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

Answer 10

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

Question 11

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

Answer 11

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

Question 12

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?

Answer 12

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

Question 13

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

Answer 13

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

Question 14

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

Answer 14

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

Question 15

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

Answer 15

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

Question 16

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

Answer 16

Women with implants were not at increased risk for most cancers including stomach, large intestine, cervix, uterus, ovary, bladder or thyroid, soft tissue sarcomas, lymphoma, and multiple myeloma. However, the cancer rates for brain and respiratory cancers were two to three times greater in the implant patients compared to other plastic surgery patients (but only the rates of respiratory cancers reached statistical significance). The significance of the increased risks is not clear and it is possible that the higher risks observed for respiratory and brain cancers are not related to exposure to silicone, but are due to either chance findings or factors common to women who choose to have implants.

Question 17

Based on the NCI Breast Implant Study, do women with breast implants have a difference in causes of death compared with women without implants

Answer 17

Women with implants were not at increased risk for most causes of death compared with the control group. The exceptions were deaths from suicide, and brain and respiratory cancers, but the significance of these increased risks is not clear.
Implant patients were three times more likely to die from respiratory tract cancer, 2 to 3 times more likely to die from brain cancer, and 4 to 5 times more likely to die from suicide than the comparison group; only the rates for respiratory cancers reached statistical significance. It is possible that these higher risks are not related to exposure to silicone, but are due to either chance findings or factors common to women who choose to have implants

Question 18

Based on the NCI Breast Implant Study, do women with breast implants have an increased risk of developing connective tissue diseases?

Answer 18

Women with breast implants were not at an increased risk for connective tissue disorders when their records were reviewed by two independent rheumatologists who did not know if the women had an implant or not

Question 19

What is the health significance of extracapsular silicone gel breast implant rupture?

Answer 19

One FDA report found an association between extracapsular silicone gel rupture and fibromyalgia. This was based on a study of 344 women who were asked if they had a diagnosis of rheumatologic or connective tissue disorder. These women subsequently had magnetic resonance imaging (MRI) to determine implant integrity and determination of silicone gel leakage outside the breast implant capsule.
Women with MRI-diagnosed breast implant rupture were no more likely than women with intact implants to report that they had either persistent symptoms or doctor-diagnosed illnesses that were listed. While women with MRI-diagnosed extracapsular silicone gel were 2.8 times more likely to report that they had the soft tissue syndrome, fibromyalgia. The limitations of this study include the following:
1. No distinction between women who developed fibromyalgia before and after breast implant surgery. 2. The women’s self-reported diagnosis of fibromyalgia was not confirmed by a medical examination.
This study does not show cause and effect, but a statistical association between extracapsular silicone and fibromyalgia

Question 20

What is the single best method to detect saline breast implant rupture?

Answer 20

Since saline breast implant rupture results in deflation of the implant and a loss of breast volume, a simple physical examination of the breast (or more likely a patient’s own observation of her breasts) will detect a rupture and subsequent deflation

Question 21

In discussion with a patient desiring breast augmentation with saline implants, what rate of implant rupture should be disclosed?

Answer 21

Since saline breast implant deflation is easy to identify (the breast losses volume over a few days), deflation rates are easier to calculate. The deflation rate is 3% to 5% of implants at 3 years and 7% to 10% of implants at 10 years

Question 22

What is the single best method to detect silicone breast implant rupture?

Answer 22

Currently, MRI is the best method to assess silicone implant integrity and diagnosis of intra- or extracapsular implant rupture. In some cases, implant rupture may be detected by mammography, breast ultrasound, or CT imaging but these modalities are less accurate

Question 23

What is the sensitivity of MRI compared to physical examination in detecting silicone breast implant rupture?

Answer 23

MRI has a sensitivity of approximately 89% in detecting implant rupture, compared to approximately 30% for a physical examination by an experienced plastic surgeon

Question 24

What is silent implant rupture?

Answer 24

Rupture of a silicone gel-filled breast implant without symptoms (silent). This is more common than a rupture with
symptoms

Question 25

What are the current government recommendations to detect silent implant rupture?

Answer 25

The recommendations are for an MRI to be done 3 years after initial implant placement surgery and thereafter every 2 years. The cost of MRI screenings may or may not be covered by insurance and should be considered by patients in making a decision regarding breast implants

Question 26

What are the signs and symptoms of possible silicone implant rupture?

Answer 26

A silicone implant rupture may be suspected by the presence of a new lump, swelling, hardening, pain or discomfort in the breast, or change in implant shape. If rupture is suspected, an MRI should be obtained

Question 27

In discussion with a patient desiring breast augmentation with silicone implants, what rate of implant rupture should be disclosed?

Answer 27

1. The two manufacturers of silicone gel implants sold in the United States each conducted a Core Study of their products.
2. Based on Allergan’s Core Study using MRI to detect silent rupture, for primary augmentation patients the implant rupture was 5.1% at 7 years. However, since each patient has two implants, the rate of patients having implant rupture was 8.6% at 7 years. Therefore, approximately 9 out of 100 women will have a rupture within 7 years of primary augmentation.
3. For Allergan’s NATRELLE silicone breast implants with an average implant age of 11 years, silent rupture was approximately 8% of the implants and 15% of patients.
4. Based on Mentor’s Core Study using MRI in primary augmentation, the silent rupture rate was 0.5% through 3 years and for revision-augmentation the rate was 7.7% through 3 years. In cases with a rupture, half were intracapsular and the other half were extracapsular

Question 28

What is capsular contracture?

Answer 28

Capsular contracture is abnormal scar tissue that forms in the normal tissue capsule around the implant and causes
tightness, compression, firmness, or pain

Question 29

What is the rate of capsular contracture in primary augmentation?

Answer 29

Based on Allergan Core Study and Mentor Core Study, the contracture rates (Baker II or IV) for primary breast
augmentation are as follows: 1. Allergan: 16% at 7 years 2. Mentor: 8% at 3 years

Question 30

How is capsular contracture classified?

Answer 30

Capsular contracture is graded into four levels based on its severity.
Baker grade I: the breast is normally soft and looks natural
Baker grade II: the breast is a little firm but looks normal
Baker grade III: the breast is firm and looks abnormal
Baker grade IV: the breast is hard, painful, and looks abnormal
Grades III and IV are considered severe and often require corrective surgery (capsulectomy)

Question 31

What is the reoperation rate for women having a primary breast augmentation with silicone gel implants?

Answer 31

Based on Allergan Core Study and Mentor Core Study, the reoperation rates (for any reason) for primary breast
augmentation are as follows: 1. Allergan: 30% at 7 years 2. Mentor: 15% at 3 years.

Question 32

What is the most common reason for reoperation in women having a primary breast augmentation with
silicone gel implants?

Answer 32

Based on Allergan Core Study and Mentor Core Study, the reasons for reoperation in women with primary breast augmentation are as follows:
1. Allergan: capsular contracture was the most common reason for reoperation followed by implant malposition and then breast ptosis.
2. Mentor: capsular contracture was the most common reason for reoperation followed by patient request for change in implant size or style and then hematoma or seroma

Question 33

What is the difference between closed capsulotomy and open capsulotomy/capsulectomy?

Answer 33

A closed capsulotomy is a method to break apart the capsular contracture by direct manual pressure on the breast by the surgeon. An open capsulotomy is a surgical procedure where the abnormal capsule is incised to “release” the scar tissue while a capsulectomy involves surgical excision of the abnormal scar tissue

Question 34

When should closed capsulotomy be performed?

Answer 34

Direct manual pressure to break the scar tissue causing capsular contracture is not recommended as this may not only rupture a silicone implant but also cause an extracapsular rupture. If the implant is already ruptured, the gel may be forced in to the breast tissue

Question 35

If an intracapsular silicone breast implant rupture is diagnosed by MRI in an otherwise asymptomatic woman, what advise should she be given?

Answer 35

A silicone implant with MRI-diagnosed rupture is considered a failed medical device and should be removed. However, the only study that followed women with ruptured implants suggests that in this case, implant removal is not mandatory. The patient needs to consider the costs and risks of removal or replacement of a ruptured implant in the absence of any symptoms. If the implant is not removed, the patient should be followed clinically for any signs or symptoms related to the implant rupture