Safety Data Are Lacking on Saline Breast Implants
While news of a $3.2-billion breast implant settlement made front-page news this year, an equally important milestone passed unnoticed: For the first time, the makers of saline breast implants provided safety data to the Food and Drug Administration.
The popularity of breast implants is at an all-time high--150,000 women received implants last year, most of which were saline. Manufacturers have begun advertising implants in national women’s magazines, with full-page ads featuring beautiful young women “having the time of their lives” and offering “the breasts you’ve always wanted with a convenient, flexible monthly payment plan.” As a result, breast implants are attracting teenagers like never before and were even on high-school teens’ holiday lists this year.
The popularity of breast implants is growing because everyone assumes that saline breast implants are safer than silicone gel implants. It seems logical because, if the implant breaks, salt water will spill out into the body instead of silicone gel. Unfortunately, nobody really knows if saline implants are safe. There are almost no published studies evaluating the safety of saline breast implants, and the FDA has never approved any saline breast implants, or any other kind of breast implants, as safe.
The outside envelope of saline implants is made of silicone, and saline implant patients have reported some terrible health problems, such as breasts that are as hard as rocks, excruciating pain and serious infections, that are clearly related to their implants. Experts on both sides of the implant safety debate concede that saline implants will break, usually after five to 15 years years, and that bacteria can grow in the implants and spill out into the woman’s body when the implants break. Moreover, many patients and their doctors have reported systemic diseases that disappear when the saline implants are taken out.
There is clear evidence in medical journals that saline implants can cause serious problems, but in the absence of objective scientific data, it is impossible to conclude how often this happens. More than a million American women already have breast implants, but the facts are known by remarkably few women, doctors or reporters. Here are some:
* 130,000 women got saline implants this year, an all-time record.
* Saline breast implants have not been evaluated in any major studies.
* Epidemiological studies reviewed by the recent Institute of Medicine report and other “expert panels” included a tiny number of women with saline breast implants--not enough to draw any conclusions. Most of the studies included no saline implants at all.
More than six years after they promised to do so, the FDA finally required the manufacturers of saline implants to submit safety studies in late November. Unfortunately, the FDA does not tell the public which manufacturers submitted safety studies and what those studies report. It will be many months before any of these studies are available to patients or doctors. When I called the manufacturers to ask about their studies, none was willing to disclose any information about them. Further, these studies are not necessarily useful to patients who want objective information because none of the studies has been published or peer reviewed and because the manufacturers have a financial interest in data that proves their implants are safe.
I recently gave a talk to health editors of women’s magazines about breast implants. Although these magazines include stories and advertisements on breast implants, not to mention featuring many models who have them, the editors were shocked to learn that saline implants were not approved by the FDA. These journalists, like most other Americans, assume that saline implants wouldn’t be on the market it they weren’t proved safe. Since they don’t know the facts, their readers are similarly uninformed.
It may not be front-page news, but it is an important step forward that the makers of saline implants have finally shown their research to the FDA. It will be even better when the teenagers and women with saline implants, including those who are promised them as gifts for themselves or their daughters, can see the studies for themselves.
