P00-11 FOOD AND DRUG ADMININSTRATION FOR IMMEDIATE RELEASE Sharon Snider: 301-827-6242 May 10, 2000 Consumer Inquiries: 888-INFO-FDA
The saline breast implants, which are made of a silicone shell filled with sterile salt water, were approved for breast augmentation in women 18 years or older and breast reconstruction.
In clinical studies required by the FDA, the companies looked at various short-term or "local" complications associated with the products, such as infection, hardening of tissue surrounding the implant (a condition known as capsular contracture), leakage/deflation, and implant removal. The firms also looked at the effectiveness parameters of patient satisfaction, body esteem, self-esteem, and breast size. Altogether some 9,000 women were enrolled in three McGhan studies and two Mentor studies.
"Although there is benefit to some women from having breast implants available, there is now a much clearer understanding of the risks involved," said FDA Commissioner Jane E. Henney, M.D. "With the data that has been presented, women and their physicians will be able to make informed decisions about whether the benefits are worth the risks."
Said David Feigal, M.D., director of FDA’s Center for Devices and Radiological Health, "It’s clear from these studies that there is a possibility that a substantial number of women who get these implants will require additional surgery at some point to remove or replace their implants because of complications.
"Women should understand that breast implants do not last a lifetime. And they should be aware that women who choose not to replace their implants after removal may have cosmetically unacceptable dimpling or puckering," he said.
McGhan’s primary study involved 901 women who received saline-filled implants for augmentation. After three years, 689 patients (76%) were still in the study. Some of the three-year cumulative risk rates were 21% for additional surgeries, 16% for breast pain, 11% for wrinkling, 10% for asymmetry, 9% for capsular contracture, 8% for implant removal, and 5% for leakage/deflation. Some women experienced more than one of these complications.
The risk rates were higher for the 237 women who received McGhan saline-filled implants for reconstruction following surgery for breast cancer or other medical problems. After three years, 169 patients (71%) were still in the study. Some of the three-year cumulative risk rates were 39% for additional surgeries, 33% for asymmetry, 25% for capsular contracture, 23% for implant removal, 23% for wrinkling, and 6% for leakage/deflation. Some women experienced more than one of these complications. Mentor’s primary study involved 1264 women who received saline-filled implants for augmentation. After three years, 955 patients (76%) were still in the study. Some of the three-year cumulative risk rates were 21% for wrinkling, 13% for re-operation, 10% for loss of nipple sensation, 9% for capsular contracture, 8% for implant removal, and 3% for leakage/deflation. Some women experienced more than one of these complications.
The risk rates were higher for the 416 women who received Mentor saline-filled implants for reconstruction following surgery for breast cancer or other medical problems. After three years, 283 patients (68%) were still in the study. Some of the three-year cumulative risk rates were 40% for re-operation, 35% for loss of nipple sensation, 30% for capsular contracture, 28% for asymmetry, 27% for implant removal, and 9% for leakage/deflation. Some women experienced more than one of these complications.
Despite the complications experienced by some women, the majority of those women still in the McGhan and Mentor studies after three years reported being satisfied with their implants; however, this does not include women who had their implants removed due to problems and were dropped from the studies.
FDA’s decision to allow continued marketing of McGhan and Mentor saline-filled breast implants was based on a review of the firms’ clinical studies, on inspection of the firms’ manufacturing facilities, and on the recommendation of the Plastic and Reconstructive Surgery Devices Panel of FDA’s medical Devices Advisory Committee.
FDA’s decision on these two saline-filled breast implants does not affect silicone gel-filled breast implants. Silicone gel-filled breast implants currently cannot be commercially marketed. They are available only to women participating in FDA-approved clinical studies designed to answer similar questions about safety and effectiveness.
Saline-filled breast implants have been marketed for over 30 years, well before FDA was given the authority to regulate medical devices. Like most medical devices marketed prior to passage of the 1976 medical device law, they were presumed to be safe and effective. However, in the late 1980s, questions began to arise about their safety. Little scientific data was available about the nature, type and frequency of problems being reported about the products. Information that was available was inadequate or conflicting, particularly about how often complications occurred. As a result, FDA decided to call for specific safety and effectiveness data from manufacturers.
Today’s action is the result of the review of marketing applications submitted by those two companies. The information that will enable women to make a fully informed decision is contained in the package insert that accompanies the products and in patient informed decision brochures. The patient labeling can be found on FDA’s website at: http://www.fda.gov/cdrh/breastimplants/. A comprehensive package of information on all types of breast implants is available at the same website.
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