NOW Calls for FDA Probe, Questions Integrity of Panel's Recommendation on Breast Implants

By NOW Staff

April 29, 2005

Last week the National Organization for Women, along with five other groups advocating for women's health, sent a letter to Congress calling for an investigation into the Food and Drug Administration's review of silicone gel breast implants. We noted a number of concerns, including: inadequate data, a possible conflict of interest on the advisory panel, the exclusion of independent scientific experts and troubling documents indicating the panel's recommendation may have been a foregone conclusion.

On April 13, an FDA advisory panel approved Mentor Corp.'s silicone gel breast implants with nine unusual and unenforceable post-market conditions. The nine conditions placed on the sale of these devices demonstrate the panel's serious misgivings about the safety of this product. Just one day earlier, the panel voted to reject rival manufacturer Inamed Corp.'s application. (The FDA's final decision is pending -- the agency is not obligated to follow the panel's recommendation but usually does.)

Last year the FDA decided not to lift restrictions placed on the sale of silicone gel implants in 1992, asking manufacturers to present data on the incidence of breast implant rupture, cause of rupture, and the long-term health effects of silicone gel leaked into the human body.

When manufacturers submitted additional information on their products, the agency's staff scientists stated that the applications had serious weaknesses, calling the industry's data "of limited value"ⁱ in the medical reviews prepared prior to the panel meeting.

Not only did manufacturers fail to deliver the information requested by the FDA, the data presented by manufacturers raised enormous red flags and displayed a disturbing manipulation of data and disregard for the public health.

The manufacturer's studies were incomplete. Two of the six implant styles presented by Mentor lacked the studies on implant rupture requested by the FDA in 2004. Of even greater concern is the fact that Mentor's core study was designed to eliminate the data from women whose implants were removed and not replaced. Patients who have their implants removed without replacement are among the most likely to have experienced rupture, complications or negative symptoms, but Mentor systematically excluded the data on those problems.

Manufacturers also ignored important toxicity issues. In January 2004, the FDA requested platinum and other toxicology analysis on tissue samples. Neither company provided this, nor was an expert on platinum appointed to the advisory panel. However, a study unveiled at the American Chemical Society's August meeting found high concentrations of platinum not only in women with silicone breast implants, but also in the children they bore and breast-fed.ⁱⁱ

Manufacturers have never submitted more than 4 years of safety data to the FDA. However, the few longer-term government-funded studies that looked at women with leaking implants showed higher rates of fibromyalgia and certain cancers.ⁱⁱⁱ These government researchers, however, were not invited to present at the last panel meeting, nor was their work mentioned by the manufacturer. Other voices, however, were heard from. The lead FDA panel advisor advocating for the re-marketing of silicone breast implants, Dr. Michael Miller, was the recipient of a $25,000 grant by an implant manufacturer.^iv

At the advisory panel meeting, women gave heartbreaking testimony of failed silicone breast implants ravaging their bodies in the same room where male plastic surgeons said that breast implants were good for women's self-esteem. The question remains: How could a medical device that has never have been proven safe be implanted into millions of women?

The pro-implant camp may claim that rigorous federal regulation protects the public, but that clearly isn't the case for the millions of women who have been implanted with unapproved breast implants. Due to a 1976 grandfather clause, regulatory loopholes allow thousands of products to be marketed every year without clinical trials. With the popularity of breast implants skyrocketing, who can say what awaits the hundreds of thousands of women who opt for breast implants every year?

If manufacturers studied the long-term health effects of silicone on the human body like the FDA asked them to, they wouldn't have to employ pricey PR firms, well-connected lobby shops or ethically-challenged panelists. But in this era of big money buying politicians and corrupting public policy, we know that dangerous drugs and devices are foisted off on an unwary public. For women who are fooled by the deceptive information of manufacturers and cosmetic surgeons, the cost is very high.

• Read the letter NOW and other groups sent to Congress.
• Learn more about NOW's work on silicone breast implants.

ⁱ Heavey, S. "FDA Staff Questions Value of Breast Implant Data." Reuters, 7 April 2005.

ⁱⁱ "Platinum Found in Women with Implants." The Associated Press, 26 August, 2004.

ⁱⁱⁱ Brown SL. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. Journal of Rheumatology, 2001;28: 996-1003; Brinton, LA. Cancer risk at sites other than the breast following augmentation mammoplasty. Annals of Epidemiology, 2001;11: 248-256.

^iv Kaufman, M, "Implant Panelist Received Grant from Maker." The Washington Post, 18 November 2004.