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Breast Implant Questions and Answers
Table of Contents

What are breast implants?
What types are approved by FDA?

How are breast implants used?

Are there any age limits with respect to who can get breast implants?

Why is the age minimum different for augmentation for saline filled and silicone gel filled breast implants?

What are the risks of breast implants?

How long do breast implants last?

What causes breast implants to rupture?

How will I know if my breast implant has ruptured?

If my breast implant ruptures, should I have it removed?

General Information About Breast Implants

  What are breast implants?

Breast implants are medical devices that are implanted either under breast tissue or under the chest muscle for breast augmentation or reconstruction. There are two major types: saline filled and silicone gel filled. Saline filled breast implants are silicone shells that are either prefilled or filled with saline during surgery, and some of these allow for adjustments of the filler volume after surgery. Silicone gel filled breast implants are silicone shells prefilled with silicone gel. Breast implants vary in profile, size, and shell surface (smooth or textured).

What types are approved by FDA?

FDA has approved four breast implants for marketing in the U.S.:

In May 2000, Mentor and Allergan (formerly Inamed) received approval for saline filled breast implants. These implants were approved for breast augmentation in women 18 years or older and for breast reconstruction in women of any age.

In November 2006, Allergan and Mentor received approval for their silicone gel filled breast implants. These implants were approved for breast augmentation in women 22 years or older and for breast reconstruction in women of any age.

All breast implants other than these four approved devices are considered investigational devices, including the more-cohesive (“gummy bear”) implants. For a woman to receive an investigational breast implant in the U.S., she must enroll in a clinical study.

How are breast implants used?

Breast implants are used for:

primary augmentation (to increase breast size for cosmetic reasons)
revision-augmentation ( revision surgery to correct or improve the result of an original breast augmentation surgery)
primary reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality)
revision-reconstruction ( revision surgery to correct or improve the result of an original breast reconstruction surgery).

 Are there any age limits with respect to who can get breast implants?

Mentor and Allergan (formerly Inamed) saline filled breast implants are approved for:

(1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and

(2) augmentation (primary augmentation and revision-augmentation) in women 18 years or older.
Mentor and Allergan silicone gel filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and (2) augmentation (primary augmentation and revision-augmentation) in women 22 years or older.

FDA restricts the marketing of breast implants for augmentation to women of a minium age because young women’s breasts continue to develop through their late teens and early 20s and because there is a concern that young women may not be mature enough to make an informed decision about the potential risks. However, there is there is no age restriction on the marketing of these products for reconstruction, so as to allow young women to have access to breast implants to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality.

Why is the age minimum different for augmentation for saline filled and silicone gel filled breast implants?

FDA approved saline filled breast implants for augmentation in women ages 18 and older. FDA approved silicone gel filled implants for women ages 22 and older. The age restrictions are different because the risks are different for the two products.  For example, silicone gel filled implants will require frequent MRI monitoring to detect silent rupture (a rupture that can go undetected by you or your doctor).  There is no risk of silent rupture for saline filled implants. In addition, the health consequences of a ruptured saline filled breast implant are different from those of a ruptured silicone gel filled breast implant.

. What are the risks of breast implants?


Some of the risks of breast implants include:

reoperations (additional surgeries), with or without removal of the device capsular contracture (hardening of the area around the implant)breast painchanges in nipple and breast sensationrupture with deflation for saline filled implantsrupture with or without symptoms for silicone gel filled implantsmigration of silicone gel for silicone gel filled breast implants.

 

 How long do breast implants last?

Breast implants do not last forever. If you decide to get breast implants, you will likely need additional surgeries on your breasts over your lifetime due to rupture, other complications (for example, capsular contracture, breast pain), or unacceptable cosmetic outcomes (for example, asymmetry, unsatisfactory style/size, wrinkling/rippling).
 
10. What causes breast implants to rupture?

We do not know all of the causes of breast implant rupture. We do know that breast implants can rupture from:

damage during implantation or during other surgical procedures
folding or wrinkling of the implant shell
trauma or other excessive force to the chest
compression of the breast during mammography.

11. How will I know if my breast implant has ruptured?

If your saline filled breast implant ruptures, you or your doctor will be able to tell. When saline filled breast implants rupture, they deflate and the saline solution leaks into your body immediately or over a period of days. You will notice that your implant loses its original size or shape.
If your silicone gel filled breast implant ruptures, it is likely that neither you nor your doctor will know. This is known as a silent rupture. This is why MRI is recommended at three years after implantation and then every two years thereafter to screen for rupture. However, sometimes there are symptoms. These symptoms include hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening of the breast.

If my breast implant ruptures, should I have it removed?

The patient labeling for the Mentor and Allergan (formerly Inamed) silicone gel filled breast implants recommends removal of ruptured implants.

What are some of the important factors I should consider when deciding whether or not to get breast implants?

Some important factors to consider include:
Breast implants do not last forever. If you decide to get breast implants, you will likely need additional surgeries on your breasts over your lifetime due to complications or unsatisfactory cosmetic outcomes.

Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implants removed and not replaced, your breasts will not change back to the way they looked before your implant surgery. You may have permanent dimpling, puckering, wrinkling, or other cosmetic changes.

When you have your implants replaced (revision), your risk of complications increases compared to your first (primary) surgery.

Routine mammograms to screen for breast cancer will be more difficult with breast implants.
Breast implants may affect your ability to breast feed, either by reducing or eliminating milk production.

Factors to consider specifically about silicone gel filled breast implants include:
If your silicone gel filled breast implant ruptures, you may have no symptoms. This is called a silent rupture because, most of the time, neither you nor your doctor will know that your implant has ruptured.

The best way to determine whether or not your silicone gel filled implant has ruptured is with an MRI examination. You should have your first MRI three years after your implant surgery and every two years thereafter.

Over your lifetime, the cost of MRI screening may exceed the cost of your initial surgery. This cost may not be covered by medical insurance.

What are “gummy bear” gel breast implants?

The so-called “gummy bear” implants are more cohesive silicone gel filled breast implants made of a firmer silicone gel filler to help maintain the shape of the implant. At this time, these breast implants are available only through clinical studies being conducted by Mentor and Allergan (formerly Inamed).


How can I report problems with my breast implants?

If you have a problem related to your breast implants and you are part of a clinical study, then it is important that you report the problem to your doctor so he/she can treat you
.
 Who can get Mentor and Allergan silicone gel filled breast implants?

The Mentor and Allergan (formerly Inamed) implants were approved for:
Breast reconstruction in women of any age. Breast reconstruction includes:
primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly; and
revision-reconstruction to correct or improve the result of breast reconstruction surgery.
Breast augmentation in women 22 years or older. Breast augmentation includes:
primary augmentation to increase the breast size; and
revision-augmentation to correct or improve the result of breast augmentation surgery.

What were the most frequent complications seen in the Core Studies for the Allergan and Mentor silicone gel filled breast implants?

In the Mentor and Allergan (formerly Inamed) Core Studies, the most frequent complication was reoperation (additional surgery). Capsular contracture was another frequent complication. Other frequent complications included implant removal, breast pain, nipple sensation changes, and asymmetry.

 

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