Testimony of Cynthia Pearson at the FDA on Saline Breast Implants

Cynthia Pearson, Executive Director National Women’s Health Network, July 9, 2002

My name is Cynthia Pearson and I am Executive Director of the National Women ‘s Health Network, a nonprofit, nonpartisan organization that has been dedicated to improving women’s health for more than 25 years.

The Network has been examining the safety of breast implants for more than a dozen years, and our primary concern has been the lack of safety information. When we first became involved in this issue, there were no studies of women in the published research literature, and although almost a million women had breast implants, no breast implant had ever been approved by the FDA. Today, there are quite a few published studies of the safety of breast implants, and saline implants made by two manufacturers are approved by the FDA. Nevertheless, the Network remains very concerned because there have been more than 150,000 adverse reaction reports to the FDA for women with breast implants, and there are still no long-term safety studies.

This meeting provides the first opportunity to re-visit the FDA’s approval of saline breast implants since they were approved in 2000. The manufacturers’ studies were strongly criticized by the FDA’s Advisory Committee two years ago because of the poor quality of their research. One might expect that the manufacturers would have been grateful that their implants were approved despite the high complication rates and poor quality of the data, and would have therefore made sure that their 5-year studies were better designed and analyzed. Instead, the new studies have many of the same flaws as the previous studies, and the response rate is even worse than it was at the PMA meeting in 2000.

I will not go into details about the statistics, because that does not seem necessary. Anyone who knows anything about research, and even many who know nothing about research, know that you can’t lose 95% of your sample and still have a meaningful study. When Mentor Corp analyzed their five-year follow-up data on only 60 of the more than 1200 women who were enrolled in their augmentation study, they did a disservice to the more than 400,000 women who underwent augmentation surgery since saline implants were approved in 2000, to you as FDA Advisory Committee members, and to the FDA. There is no excuse for that kind of shoddy research — in fact, it does not deserve to be called research. It is meaningless data. The fact that Mentor improved their follow-up to 24 percent at the six-year mark shows how little attention went into their 5-year study, but even a 24 percent response rate is much too low to be meaningful.

A response rate under 50 percent raises more questions than it can answer: are the other women dead or alive? Are they healthy and happy or sick and seeking medical care elsewhere? We don’t know the answers to those questions, so the data can’t really tell us about the safety of implants.

The McGhan data are little better. Like the Mentor study, they manipulate the data to make it seem that saline implants are safer than they really are. Both Mentor and McGhan made note of the women who had both their implants removed, but they are not included in the complication rate data. Instead, they are apparently excluded from the study as if they never existed — or worse, as if they were satisfied with their implants or had the same complication rate as everyone else. Even with this highly inappropriate data manipulation, approximately one out of every three McGhan augmentation patients is described as undergoing 463 additional surgical procedures — an average of more than two additional surgeries per patient

Consumers deserve an FDA that keeps unsafe or ineffective medical devices off the market. They also deserve accurate information about the long-term safety of medical implants that are intended for long-term use. In the case of breast implants, the manufacturers have failed to conduct meaningful long-term safety studies and as a result consumers are continuing to buy implants that are FDA-approved but are not necessarily safe. All we do know is breast implants have an extremely high complication rate — higher than any medical product I can think of, with the exception of a small number of life-saving products used by patients who have no other choices. Even the misrepresentation of data does not hide that fact.

On behalf of the National Women’s Health Network, I strongly urge this Advisory Committee to speak on behalf of the millions of consumers who are not able to come to this meeting, but who look to the FDA to protect them from harmful products. If this Advisory Committee does not vehemently criticize these studies, and the manufacturers’ misrepresentation of their own research, and urge the FDA to take a stronger watchdog role, breast implants will never be improved, and accurate and informative research will probably never be conducted.

Third, the cost of reoperations and local complications associated with breast implants can be significant for both the patient and society. Many health plans do not cover the medical costs associated with cosmetic breast implant complications — forcing many patients to cover these costs out-of-pocket. For example, Aetna — one of the nation’s largest health insurers — does not cover the cost of removing ruptured saline implants in patients who have previously undergone cosmetic breast augmentation. It should be noted that in 2001, more than 62,000 breast implant removal procedures were performed in the U.S.

This statement was read by Tonia Bair, because Ms. Pearson was unable to attend the meeting.