"More women are getting breast implants than ever before. In 2000, a total of 203,310 women underwent breast implant surgery for augmentation, and 82,975 women underwent breast implant surgery for reconstruction after mastectomy in 1999 (the most recent statistics available). The number of women and teenage girls who chose implants to augment their breast size more than doubled between 1997 and 2000."

These statistics are from a commentary written by Diana Zuckerman, president of the National Center for Policy Research for Women & Families and a longtime critic of the breast implant industry.

The Food and Drug Administration has strictly limited use of the most popular type of implant -- the kind filled with silicone gel -- after reports that it might cause debilitating illnesses.

Who manufactures implants in the US?

Two main implant manufacturers in the United States:

• Inamed Aesthetics: Officials at Inamed Corp., have said they are finishing clinical studies of silicone gel implants and hope to apply for an FDA review later this year. The United States is the only major country where silicone gel implants are limited.

• Mentor Corp, Inc.: Mentor Corp. of Santa Barbara, Calif. is going through a criminal investigation focused on Mentor's research procedures and allegations of document destruction and faulty manufacturing. The company has also been criticized for the limited contact the FDA has been able to create with women in a follow-up study. Mentor also just announced that it will build a large silicone implant facility in the Netherlands.

What are the known risks of implants?

These are known risks, as maintained by the FDA:

Surgical Risks:

• Possible complications of general anesthesia, as well as nausea, vomiting and fever
• Infection
• Hematoma (collection of blood that may cause swelling, pain and bruising, perhaps requiring surgical draining)
• Hemorrhage (abnormal bleeding)
• Thrombosis (abnormal clotting)
• Skin necrosis -- skin tissue death resulting from insufficient blood flow to the skin.
  The chance of skin necrosis may be increased by radiation treatments, cortisone-like drugs, an implant too large for the available space, or smoking.

Implant Risks:

• Autoimmune diseases
• Capsular contracture (hardening of the breast due to scar tissue)
• Leak or rupture -- silicone implants may leak or rupture slowly, releasing silicone gel into surrounding tissue; saline implants may rupture suddenly and deflate, usually requiring 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."

Are women choosing saline-filled or silicone implants?

Many American women have turned to the saltwater-filled alternative implants with the current restriction on saline implants. Public health advocates and physicians remain alarmed about implants of all types. The research confirms that planting a device in a woman's breast can cause serious, predictable and often costly complications. The same public health advocates maintain that the FDA is not providing American women the information and protection they need.

What is the most common breast implant problem?

Pain and hardening from the scar tissue around the implants are common, but the biggest medical issues involve implant deflations, as saltwater leakage can contribute to infections. The health risks from leaking silicone implants remain controversial. Research by the FDA and National Institutes of Health has recently found increased fibromyalgia (a disease of generalized pain and tenderness) in women with silicone implants, as well as an increase in brain cancer.

Why is fueling this breast implant phenomenon?

Recent research shows that the willingness of many women to undergo breast augmentation is closely linked to their body image. The research shows that women are getting implants in their twenties through their forties. More than 5,000 procedures in the past two years are for women under 18 years of age. Research has postulated that many American women desire cosmetic surgery due to the highly idealized body image presented by the Western media.

What does this mean for the modern woman?

The implications of this trend are serious, not only for a woman's health, but also for her financial security or overall well-being. The money that a woman spends on breast augmentation doesn't go into her 401(k), investments, vacations or down payments on a home.

Plast Reconstr Surg 2002 Jan;109(1):363-9; discussion 370-1

Plast Surg Nurs 2002 Summer;22(2):66-71.