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FDA Opens Breast Implant Review

April 11, 2005

Breast Implants • FDA's Breast Implant Decision Shows 'Double Standard,' Critics Charge • Safety of Silicone Gel Breast Implants Questioned • FDA Gets Conflicting Recommendations on Silicone Breast Implants • FDA Opens Breast Implant Review

The Food and Drug Administration's advisory panel on General and Plastic Surgery Devices meets this week to review data on the safety of silicone breast implants. The panel will vote Tuesday on Inamed Corporation's application for approval, and on Wednesday on Mentor Corporation's application.

"This is the third time both companies have applied for FDA approval" said Dr. Diana Zuckerman, president of the National Research Center for Women & Families. "The first unsuccessful effort was in 1991, so the companies have had more than enough time to study these products? Why have they provided no long-term safety data?"

Both companies applied for FDA approval again in 2002-3, but Mentor withdrew its application when Inamed's implants were not approved in January 2004.

When the FDA refused to lift restrictions on the sale of silicone gel-filled breast implants at that time, the FDA explained their decision was based on concerns about rupture, unknown complication rates, and the long-term safety of silicone in the body.

Last week, the FDA publicly released its scientific review of the companies' applications. The group says the reviews indicate that FDA scientists found that the industry data are insufficient to answer many of their concerns. In addition, it points to data it says reveal significant problems with the devices.

Rupture

The FDA's probability analysis, provides several estimates based on industry data. Assuming that implants, like other products, are more likely to break as they get older, the most realistic estimate indicates that three-quarters of implanted women will have at least one ruptured implant within a decade of receiving the devices.

Specifically, these data estimate that 93% of breast cancer reconstruction patients should expect at least one broken implant, 38% of augmentation patients, and 66% of women who replace previous breast implants with new ones.

Leakage

Approximately one in four women have silicone leaking outside their scar tissue capsules, and silicone seepage increases over time.

When that happens, women are more likely to report breast hardness, fatigue and other auto-immune symptoms, and, perhaps, auto-immune diseases.

Other problems include painful hardening of the breast, changes in nipple sensation, dying breast tissue, and other complaints.

Long-Term Safety

While the data submitted by the manufacturers did not provide evidence of long-term safety, other researchers have conducted studies that indicate increased risks:

National Cancer Institute researchers found that women with implants were twice as likely to die of brain cancer, three times as likely to die of lung cancer, and four times as likely to commit suicide, compared to other plastic surgery patients.

FDA scientists studied women who had silicone breast implants for at least six years, and found that women with extracapsular silicone leakage were significantly more likely to report a diagnosis of painful and debilitating diseases such as fibromyalgia.

A Canadian study found that women with breast augmentation were more likely to be hospitalized compared to other women of the same age in the same communities, and augmentation patients also had more medical visits.

Mammography

Breast implants interfere with the detection of breast cancer. A study published in the January 2004 of the Journal of the American Medical Association (JAMA) found that mammograms missed 55% of breast cancers in women with breast implants, compared to 33% in women without implants.

After hearing the manufacturer's data at the 2003 October panel meeting, advisory panel chairman Dr. Thomas Whalen wrote a letter to the FDA dated October 31 where he noted that mammography was a key concern, writing that "[t]here is at least one facet of long-term danger that was established during the panel -- specifically the obscuration of surrounding normal breast tissue to mammographic detection of breast cancer."

Toxic Chemicals

An article published in the Annals of Bioanalytic Chemistry reported alarmingly high levels of a dangerous form of platinum in children born to women with breast implants. Platinum is a known toxic chemical.

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