Silicone Breast Implants: The Debate Continues

The safety of silicone gel-filled breast implants has been debated for years. On April 16, 1992, the Food and Drug Administration (FDA) banned the use of silicone gel-filled breast implants, except in very specialized cases. This ban happened after women with these implants reported many serious health problems. These are just some:

breast pain fatigue muscle pain joint pain hair loss problems with walking, balance, and seeing memory loss Fibromyalgia

chronic fatigue Hashimoto's thyroiditis Autoimmune-related thyroid disease chronic pain migraine headaches aches numbness and tingling in the calves, toes, and fingers facial paralysis

So for many years, silicone gel-filled breast implants were not available to the general public. On October 16, 2003, an FDA advisory panel recommended that the government approve the use of silicone gel-filled breast implants under certain conditions:

• Patients sign consent forms.
• Doctors give brochures about breast implants to patients.
• Patients get regular exams to check for leaks.
• Patients get a physical exam and MRI (a type of x-ray of the breast and the implant) at five, seven, and nine years after they get the implants.
• Inamed, the implant manufacturer, retrieves and studies failed implants and reports their findings to the FDA.
• Inamed sets up a toll-free phone number for women with implants.
• Inamed creates an education and certification program for surgeons.
• Inamed will track patients who have breast implants.

On January 7, 2004, the FDA rejected the advisory panel’s recommendation and Inamed’s bid to put silicone breast implants on the market at this time. The FDA is going to continue to review the safety of silicone gel-filled breast implants. Inamed plans to seek approval from the FDA again.

On April 12, 2005, the FDA advisory panel did not approve Inamed's application for approval of its silicone breast implants. However, on April 13, 2005, the FDA advisory panel did vote in favor of recommending to the FDA that Mentor's silicone breast implants be approved for the U.S. market, under these conditions:

• Patients will sign consent forms acknowledging they understand the risks of implants.
• Mentor can only sell the implants to board-certified plastic surgeons. The surgeons must complete a training on inserting the implants.
• Mentor must track how patients tolerate the implants. They must also conduct formal studies on implant rupture.
• Mentor must warn patients that because implant breaks don't cause immediate symptoms, they should get an MRI scan five years after implant insertion and every 2 years after that. Patients should also think about having broken implants removed.

Here's what interested parties have said about silicone gel-filled breast implants:

FDA Advisory Panel in favor of FDA approval of silicone gel-filled breast implants	There was enough evidence to show that silicone breast implants are safe and effective. Informed consent will be given. Patients should have all implant options available to consider. We will continue to look at the problems women have from these implants. There will be long-term follow-up of implant users.
FDA Advisory Panel against FDA approval of silicone gel-filled breast implants	There is not enough information about the long-term safety of silicone gel-filled breast implants. We don’t know the impact of silicone in the body if the implant ruptures.
Inamed Corporation (makers of silicone gel-filled breast implants)	Silicone implants break and cause other problems no more often than saline implants, which are implants filled with salt water. The implant now has a thicker shell. In most countries in the European Union, silicone gel-filled breast implants were never taken off the market, and have been available for 30 or more years in countries like Italy , Germany and the United Kingdom . There is no evidence that silicone gel-filled breast implants having any long-term adverse health consequences. Silicone breast implants have fewer complications than saline breast implants. Researchers have found no increased risk of breast cancer, no increased risk of rheumatic or autoimmune disease, and no negative effects of breast implants and breastfeeding on children's health.
Researchers	It has not been scientifically proven that silicone breast implants cause health problems related to the immune system and to the connective tissue of the body, like the muscles, tendons, and bones. At this time, studies have not been large enough to know if breast implants raise the risk for these health problems. FDA study reports a potential risk of developing fibromyalgia from rupture of breast implants. National Cancer Institute (NCI) found no convincing evidence that breast implants have an effect on the development of subsequent connective tissue disorders (CTDs). Studies report leaked silicone from implants can cause problems like pain, infection, disfigurement, and the potential for scarring at the site of the implant. Other studies found that women with silicone breast implants had a higher risk for suicide, brain cancer, respiratory cancers, pneumonia, and emphysema.
General support in favor of FDA approval of silicone gel-filled breast implants¯consumers, doctors, advocacy groups, and others	Silicone breast implants are better than saline implants for women undergoing breast reconstructive surgery. They are safe. Women have a right to choose which implants they want. Silicone implants look and feel better. Illnesses occur with the same frequency in women with breast implants and women without breast implants.
General opposition to FDA approval of silicone gel-filled breast implants¯consumers, doctors, advocacy groups, and others	If silicone breast implants break, silicone leaks slowly and there are no symptoms, allowing it to travel throughout the body. Leaking silicone from breast implants cause serious health problems and are dangerous to women. We don’t know why implants fail. We don’t know how implant failure will affect the children and the second generation of mothers who have been exposed. We don’t know the long-term health effects of implant rupture.

Updated April 2005

Publications

1.   Breast Implants
   This site provides information about breast implant studies, mentor information, breast implant complications, and other resources. It also includes the FDA breast implant consumer handbook.

2.   FDA Breast Implant Consumer Handbook - 2004
   This handbook contains the latest information about breast implants to assist you in making an informed decision about whether or not to have breast implants. It includes potential complications, issues to consider, and breast implant resource groups.

3.   Photos and Illustrations of Breast Implant Complications
   This publication explains common complications that may occur with silicone and saline breast implants. Photos of capsular contracture, rupture or deflation, and breast implant removal with out replacement are displayed.

Organizations

1.   Food and Drug Administration, HHS

2.   National Institute of Environmental Health Sciences, NIH, HHS

3. Mayo Foundation for Medical Education and Research

http://www.womenshealth.gov/BodyImage/implants.cfm