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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% 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.)
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.
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.
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).
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 MIDWIFE OR HEALTH CARE PROVIDER IF...
You have questions or concerns about breast implants.
MoonDragon's Obgyn Information: Procedures - Breast Surgery Index
BREAST LINKS
Links about breast augmentation and implant safety. MoonDragon provides these links for informational use only.
Alt.Support.Breast-Implant
Breast Implant Disease Skeptic's Page - essays and links to information skeptical of claims that silicone breast implants contribute to disease in women. Breast Implant Hot Spot - call to action for thousands of women who have been negatively affected by silicone breast implants.
Breast Implants - information on health effects of breast implants and information concerning litigation.
Breast Implants on Trial - PBS Frontline special from 1997.
Coalition of Silicone Survivors
Operation Commitment and Hope for Silicone Implant Survivors
Silicone Gel Breast Implants - report of the Independent Review Group.
Status Report on Breast Implant Safety - from the FDA.
Usenet - alt.support.breast-implant
The Real World DANGERS of Surgical Implants - This page deals with Breast Implant surgery and Breast Cancers. The possible pressure on some Plastic Surgeons to do what best for their pocket books
--http://www.newwomyn.com/nw008.html
Breast lift and reduction preface - View surgery sketches Preface | the surgery | post-op | possible complications | Mastopexy (breast lift) and reduction mammoplasty (breast reduction) are somewhat similar. These operations are both aimed at remodeling the breast. The reduction does
--http://www.plasticsurgery.ca/breast liftreduc.htm
Breast - Survivors Back Breast Implant Study (12/06/1998) Survivors Back Breast Implant Study By Kaja Perina Associated Press Writer Thursday, June 11, 1998 WASHINGTON (AP) -- Convinced that silicone breast implants cause years of illness and follow-up..
--http://www.health.fgov.be/WHI3/krant/krantarch98/kranttek...
No Title - 1993.01.05 : Saline Breast Implants Contact: Susan Cruzan - (301) 443-3285 (Home) -- (301) 926-7081 January 5, 1993 The Food and Drug Administration today announced a proposal that manufacturers of saline breast implants be required to submit..
--http://keepinformd.com/HHS/PR/1993/01/930105.txt
Healthline Magazine - The Breast Implant Debate - Please visit our Sponsor Magazines Healthline Skin Care Today Allergy & Asthma Information Subscriptions About Healthline Contact Us Disclaimer Sponsorship Health Links Home WOMEN'S HEALTH From: Healthline, January 1995 The Breast Implant Debate..
--http://www.healthline.org/articles/oldfiles/hl950105.html
Breast Implants - Breast Implants Title:Risk of connective-tissue diseases and other disorders after breast implantation Authors:Gabriel, S.E.; Fallon, O.; Michael, W.; Kurland, L.T.; Beard, C.M.; et al Journal:New England Journal of Medicine 330(24); June 16, 1994.
--http://www.life-research.edu/breasts.html
Breast Implant Safety - Breast Implant Safety Article by Dr. Zoltan P. Rona MD MSc Since 1962, between one and two million women have had silicone breast implants to enhance their physical appearance. Also since that time, thousands of women in North America have..
--http://www.srvitamins.com/Articles/BreastImplantSafety.htm
Important Information we would like you to read - We suggest you start with the Plaintiffs Science Submission it is long but has more facts and studies to help you and maybe your doctors understand how and why silicone can be harmful. Due to the lack of room we were unable to provide all of the..
--http://womnhlth.home.mindspring.com/Things%20You%20Need%2...
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