Breast Implants: Know the Facts

Breast implants are bags of silicone gel or saline that cosmetic surgeons implant behind existing breast tissue or above the breast muscle in order to enhance or enlarge a woman's breasts. There are three basic types of breast implant surgery: augmentation, revision, and reconstruction and the reasons for the surgery are as myriad as the individual. Some women choose augmentation because they are unsatisfied with their breast size or shape and simply want to look better in their clothing. Some believe that it will help their self-esteem, making them feel better about themselves.

Breast augmentation is a cosmetic procedure, while breast reconstruction is a medical issue procedure, rebuilding breasts after cancer, illness, or injury. Breast revision adjusts existing implants from either augmentation or reconstructive surgery. 

Implants have been subject to most of the controversy surrounding cosmetic and breast reconstructive surgery as well as the center of numerous lawsuits--particularly if the implant broke or illness resulted from the breakage. Although many cosmetic surgeons regard silicone gel implants as safe, the Food and Drug Administration (FDA) deems the implants suitable only in certain reconstructive conditions and by informed consent.

Breast Implant Basics

The FDA has found that most breast implants last around a decade before needing revision or before rupturing. Around 85 percent of all augmentation is done using saline implants, costing the consumer about half the price of silicone gel implants. However, saline doesn't feel as natural and slight wrinkling is the norm.

Silicone gel implants are made up of a shell several layers thick of silicone rubber. They are prepackaged and not filled during surgery as saline implants are and cannot be micro adjusted. Silicone implants come in sizing from the smallest 25 cc to largest 400 cc, have a natural, soft feel, and wrinkle less than saline. 

• Consumer Guide to Implants Articles about breast implants, their makeup, and safety. Reviewed by doctors.

• Breast Augmentation Surgery Are you a good candidate? What to expect during a consultation and the surgery.

• Breast Reconstruction Surgery After a mastectomy, with photos.

Statistics (American Society of Plastic Surgeons, 2008)

Breast augmentation surgeries have taken a hit with the economy and are down 12 percent from 2007; yet despite the economic downturn, 39 percent of plastic surgery is breast reconstruction. Breast implant removal for augmentation patients was down 22 percent and breast lifts were down 11 percent. Women made up 100 percent of these patients in 2008. The average cost of breast of breast augmentation is $3348 while breast implant removal runs $2435.

Breast reduction in men costs an average of $3282 and is down 16 percent. This was the number four cosmetic procedure for men. Males between the ages of 13 and 19 make up 79 percent of the patients.

Breast implant removal for reconstructive patients is up 37 percent and breast reduction is down 16 percent.

• 2009 Report on 2008 Plastic Surgery Statistics A comprehensive statistical report breaking down surgery by type, cost, gender, trends, and location.

Controversies

The first silicone gel breast implants in the United States were sold in the 1960s and were unregulated. By the 1990s, over a million women had breast implants and the number was growing although concerns about the implants were becoming known to the medical world.

Congress gave the FDA the authority by law to review the enormous amount of implant devices on the market in the 1970s. In 1978, concerned scientists and doctors expressed their concerns at an advisory meeting, women who had negative experiences with silicone gel testified in the 1980s, and by the 1990s, the FDA mandated that silicone gel implants could only be used in clinical trials, reconstructive surgery or for broken gel replacement.

Silicone gel breast implants were approved by the FDA in 2006 for women age 22 and over. Manufacturers are required to conduct a 10-year study among 80,000 women due to safety concerns.

Saline implants weren't reviewed until 2000. They have a silicone outer shell and are filled with saline, which is salt water. Saline had a high complication rate of around 75 percent, yet the FDA approved the implants and made risk information available more readily to consumers.

• Implants on Trial Public Broadcasting's Frontline examines "The Clash of Medical Evidence and the Law in the Breast Implant Case."

• Tort Law: Breast Implant Lawsuits Discusses class action lawsuits and possible punitive damages resulting from breast implant cases. Good chance to see from a law point of view.

• FDA Breast Implant Timeline Regulatory history of the FDA and silicone gel breast implant controversy.

 Risks

In order for consumers to make an informed decision to consent to breast implant surgery, the FDA has disseminated information regarding past complications and potential risks such as breast pain, hardness and nipple numbness, which are common; and, toxic shock syndrome and gangrene as less common complications. After implant surgery with either silicone or saline, most patients have at least one serious complication within three years.

Other risks and considerations include:

• Many augmentation patients need revision surgery within five years, most within a decade. Augmentation surgery can affect breastfeeding and there are serious concerns whether implant leaks can harm nursing babies.
• Forty percent of reconstruction patients needed additional surgery within three years.
• Some implants break within days or weeks of surgery.
• Consider that implants age and experience a natural breakdown of material or rupture. Mammograms can cause implant rupture if performed by inexperienced technicians.
• Closed capsulotomy is a dangerous procedure, no longer recommended, where the doctor attempts to break a scar tissue capsule (capsular contracture) with his hands by squeezing the breast very hard. Capsular contracture is when the scar tissue contracts and squeezes the soft implant creating breast hardness of the skin.

• Breast Implants The FDA site on consumer information with links to MEDWATCH to report any problems with your implants and for resource groups.

• What You Need to Know From the National Research Center for Women & Families regarding information about breast implants. Written by nurses.

• The Implant Information Project Objective information regarding breast augmentation, reconstruction, and safety. Personal stories and news included.

All breast implant cosmetic surgeons should be board-certified plastic surgeons. Consider the psychological aspects of implant surgery, possible disfigurement, and permanent neurological loss of feeling before undergoing any breast implant surgery. Breast implant surgery is a quality of life issue. Make an informed decision that is right for you.

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