DESCRIPTION

Breast implants have been marketed since the early 1960's - long before the first medical device law was enacted in 1976 that gives regulation authority to the FDA (Food and Drug Administration). Every year, thousands of American women have had implant surgery for augmentation (to enlarge or reshape their breasts) or for reconstruction following a mastectomy (removal of the breast) to treat breast cancer. Most of the implants consisted of rubber silicone envelopes filled with silicone gel; about 10 percent were filled with saline (salt water). A growing number of adverse reaction reports raised safety concerns about the breast implants. The FDA ordered the silicon-filled implants off the market in April 1992. They remained available only to women in clinical studies, mostly women seeking breast reconstruction after breast cancer surgery. The saline-filled implants were allowed to stay on the market for both reconstruction and augmentation.

(Information in this page adapted in part from the FDA Consumer magazine.)

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MEDICAL STUDIES ON IMPLANTS

Numerous medical studies have been conducted and more are ongoing to assess the risks of the breast implants.

Some recent studies comparing the rate of immune-related diseases in women with implants do provide some reassurance to women with implants that they are not at a greatly increased risk of these disorders.

Several studies have indicated there is not increased risk of breast cancer in women with implants. However, many of the women are not yet in the age group that is more prone to cancer so future effects are unknown. Long-term studies to look at this are underway.

Other ongoing studies are intended to assess:

• Short-term safety data.


• Rates of capsular contracture.


• Rupture.


• Complications such as infection.


• Hematoma (collection of blood that may cause swelling, pain and bruising).


• Quality-of-life benefits.


• Extent of interference with mammography, and other safety concerns.

Though saline-filled implants are still available (they are considered less risky) studies are being conducted on them as well.

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KNOWN RISKS OF BREAST IMPLANTS

Surgical Risks:

• Possible complications of general anesthesia, as well as nausea, vomiting and fever.


• Infection.


• Hematoma.


• Hemorrhage (abnormal bleeding).


• Thrombosis (abnormal clotting).


• Skin necrosis (skin tissue death).

Implant Risks:

• Capsular contracture (hardening of the breast due to scar tissue.


• Leak or rupture (silicone implants may leak or rupture slowly, releasing silicone into surrounding tissue); saline implants may rupture suddenly and deflate (usually requires immediate removal or replacement).


• Temporary or permanent change or loss of sensation in the nipple or breast tissue.


• Formation of calcium deposits in surrounding tissue, possibly causing pain and hardening.


• Shifting from the original placement, giving the breast an unnatural look.


• Interference with mammography readings, possibly delaying breast cancer detection by "hiding" a suspicious lesion. Also, it may be difficult to distinguish calcium deposits formed in the scar tissue from a tumor when interpreting a mammogram. Advise and mammogram technician that you have implants.

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POSSIBLE RISKS OF BREAST IMPLANTS

Autoimmune or connective tissue disorders - signs include:

• Joint pain and swelling.


• Skin tightening.


• Redness or swelling.


• Swelling of hands or feet.


• Rash.


• Swollen glands or lymph nodes.


• Unusual fatigue.


• General aching.


• Greater chance of getting colds, viruses and flu.


• Unusual hair loss.


• Memory problems.


• Headaches.


• Muscle weakness or burning.


• Nausea or vomiting.


• Irritable bowel syndrome.

Recent studies have shown there is not a "large" increased risk.

Fibrositis/fibromyalgia-like disorders (pain, tenderness and stiffness of muscles, tendons and ligaments).

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CONSIDERATIONS

For cosmetic breast enlargement - saline-filled implants are the only type currently available. Prior to any surgery, information will be provided that details risks and benefits and a consent form will need to be signed.

For breast reconstruction following mastectomy - both silicone-filled and saline-filled implants are currently available. Prior to surgery, information will be provided that details risks and benefits of each and a consent form will need to be signed.

Women with existing implants - should see their health care provider if any symptoms listed as known risks or possible risks develop. Recognize that many of these symptoms can be caused by a number of disorders that have no association with breast implants.

For additional information about breast implant issues, request FDA's publication, "Breast Implants, An Information Update." by calling the agency's breast implant information line at (800) 532-4440.

NOTIFY YOUR HEALTH CARE PROVIDER IF...

You have questions or concerns about breast implants.

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RELATED BREAST SURGERY LINKS

MoonDragon's ObGyn Womens Health Information: Procedures - Breast Surgery Index

MoonDragon's ObGyn Womens Health Information: Procedures - Breast Augmentation & Safety

MoonDragon's ObGyn Womens Health Information: Procedures - Breast Reconstruction After Mastectomy

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BREAST IMPLANT LINKS

Links about breast augmentation and implant safety. MoonDragon provides these links for informational use only.

BreastImplantSafety.org: For Unbiased, Science-Based Information On Breast Implant Options

FDA: Medical Devices - Breast Implants

WebMD: Breast Implant Safety: Risks and Safety Information About Silicone & Saline Breast Implants

BreastImplants.org: Breast Augmentation, Breast Reconstruction, & Breast Implant Information

Wikipedia: Breast Implant

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