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What you need to know about breast implants

Breast implants are indicated for breast augmentation and reconstruction, but neither the manufacturers and the recipients of the medical devices might never thought of another possible application: identification of the recipients.

News media reported that a 28-year-old former model named Jasmine Fiore was murdered in California and her fingers and teeth were removed leaving police in Orange County city clueless about the identity of the dead body packed in a case dumped in a park until a serial number on the breast implants was found.

Authorities now suspect that a man known as Ryan Alexander Jenkins murdered Fiore.  Ryan Alexander was married to Fiore in March 2009 and Fiore's mother was cited as saying the marriage ended a couple of months later. But no court documents confirmed the claim, The AP reported.

News media reported that now Mr. Jenkins fled back to Canada.  Authorities have offered a reward of $25,000 for any information that leads to Mr. Jenkins' arrest.

Below are the general information a woman may be interested in knowing regarding breast implants.  The content slightly edited is cited from the FDA.  All opinions belong to the agency. (david liu)

What you need to know about breast implants

1. 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.


2. What types are approved by FDA?
Two major types of breast implants, saline-filled and silicone gel-filled, have gained FDA approval.

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).

As of today, 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.

Other types of breast implants are considered investigational devices, including the more-cohesive (“gummy bear”) implants. Women who would like gummy bear have to be enrolled in clinical trials.


3. 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).

4. Are there any age limits with respect to who can get breast implants?
Saline-filled breast implants are approved for: (1) reconstruction in women of any age and (2) augmentation in women 18 years or older.

Silicone gel-filled breast implants are approved for: (1) reconstruction in women of any age and (2) augmentation in women 22 years or older.

One reason that FDA restricts the marketing of breast implants for augmentation to women of a minimum age is 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.

There is no age restriction when breast implants are used for reconstruction.

5. 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 pain
changes in nipple and breast sensation
rupture with deflation for saline-filled implants
rupture with or without symptoms for silicone gel-filled implants
migration of silicone gel for silicone gel-filled breast implants.
For a more complete description of the possible risks and complications of breast implants, see Breast Implant Consumer Handbook: Local Complications and Reoperations.


6. How long do breast implants last?
Breast implants will not work for you for your lifetime.  When you decide to get breast important, keep in mind that you will likely need additional surgeries on your breasts due to a number of reasons including rupture, other complications (for example, capsular contracture, breast pain), or unacceptable cosmetic outcomes (for example, asymmetry, unsatisfactory style/size, wrinkling/rippling).


7. What causes breast implants to rupture?
No one knows for sure what causes breast implant rupture. But some possible reasons include:

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.

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

Silicone gel-filled breast implant ruptures are more complicated and neither you nor your doctor will know. Because of this, MRI is recommended at three years after implantation and then every two years thereafter to screen for rupture.

However, sometimes there are symptoms including 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.

9. 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.

10. Will the platinum in silicone breast implants harm me?
Based on the existing literature, FDA believes that the platinum contained in the implant shell and gel is in the zero oxidation state, which poses the lowest health risk. This is further supported by the available biocompatibility testing, gel bleed testing, and clinical data on these implants.


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

a) 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.

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

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

d) Routine mammograms to screen for breast cancer will be more difficult with breast implants.

e) 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.

For additional factors to consider, see the Labeling for Approved Breast Implants.


12. How can I report problems with my breast implants?
You should report the problem to your doctor and ask your doctor to report the problem to FDA. You can also report your problem to FDA yourself through FDA’s MedWatch system or by calling 1-800-332-1088.


13. What were the most frequent complications associated with silicone gel-filled breast implants?
The most frequent complications include reoperation (additional surgery), capsular contracture. Other frequent complications included implant removal, breast pain, nipple sensation changes, and asymmetry.