FDA Study Shows That Most Silicone Gel Filled Breast Implants Rupture

Patricia Lieberman, PhD and Diana Zuckerman, PhD, National Center for Health Research

Image result for gel implants breast
Gel implants outside of the body

While the Food and Drug Administration (FDA) has warned consumers that “breast implants do not last a lifetime,” new FDA studies by Dr. Lori Brown and her colleagues indicate that most women with silicone gel-filled breast implants will have at least one broken implant within 10 years. In the first study, the FDA interviewed 907 women in the Birmingham, Alabama area who had breast implants for at least six years. In the second study, 344 women with silicone gel breast implants who had been interviewed in the first study and had not had additional surgery after getting their implants received a Magnetic Resonance Imaging (MRI) exam, to determine whether their implants were broken.

Interview Study

In the Interview Study, women with breast implants were asked if they had any additional breast surgery after getting their implants. If their implants were removed, they were asked why. Women who had surgery because they suspected their implants were ruptured were asked about what symptoms they had and whether they knew of a possible reason that their implants could have ruptured.

One-third of the women interviewed (303 of 907) reported that they had at least one operation to remove or replace a breast implant. Of the women who had additional surgeries, more than half reported that at least one of their implants was ruptured or leaking. The average time between getting implants and having additional surgery was 11.5 years.

The most common reason for additional surgery was due to complications such as pain, capsular contracture, displaced implant, infection, or a suspected rupture. Those complications occurred in 103 of the 303 women who had additional surgery. An additional 92 women had their breast implants removed because they were concerned about the safety of silicone.

Some women had additional surgery because of diseases or because they had symptoms that they or their doctors thought were due to the implant. Other women had additional surgery that was planned or staged, such as replacing tissue expanders, or to get a different size implant.

Of the 73 women who suspected their implant had ruptured, 51 suspected the rupture because they had pain in their breast, chest, or upper body. Thirty-five suspected rupture because of changes in their breast shape.

Since self-reported medical history is not always accurate, the FDA attempted to check to determine if the women’s reports were accurate. The FDA was able to obtain medical records from about half of the women who had additional surgeries, and found that the women’s reports were quite accurate. There were minor discrepancies between what the women reported and what was recorded in their medical records. Those differences could have been because researchers may have reviewed a medical record from a different surgery than the one the woman reported, the doctor might not have recorded whether an implant had ruptured, or the woman could have been mistaken that her implant was ruptured. In order to eliminate those biases, the FDA performed a second study, using MRIs. The MRI Study, described below, showed even higher rates of implant rupture than the Interview Study.

MRI Study

The FDA recruited women from the Interview Study to have a Magnetic Resonance Imaging (MRI) exam to determine if their implants were ruptured. The study looked at 344 women who had 687 silicone gel-filled breast implants and who did not suspect that their implants were broken. The average time a woman had implants was about 17 years. Three radiologists looked at each of the MRIs and determined if the implants were intact, suspicious for rupture, or ruptured.

Since the study excluded the one-third of the women in the Interview Study who already had their implants removed due to breakage or other complications, the actual rupture rate is even higher than this study reports. More than two-thirds (69 percent) of the women who had not previously had surgery were found to have at least one ruptured implant in the MRI Study.

Almost half (48 percent) of the women who had implants for only six to 10 years had at least one ruptured implant. Even more, 79 percent, of the women who had implants for 11-15 years had at least one ruptured implant, and similarly, 72 percent of women who had implants for 16 to 20 years had at least one ruptured implant. The rupture rate was lower, approximately one in three, among the few women who had implants for 21 years or more. This is probably because implants made prior to 1975 were made with thicker envelopes and thicker silicone gel.

Of particular concern was whether the silicone migrated outside of the scar tissue that surrounds the implant. Migrating silicone is almost impossible to surgically remove, and efforts to remove it can result in surgery resembling a mastectomy. The findings were bad news for patients with gel implants: the radiologists agreed that more than one in five women (21 percent) had silicone gel that had migrated, and could therefore potentially migrate to essential organs.

There were several factors that affected the likelihood that an implant had ruptured, such as the age of the implant, which manufacturer made the implant, and whether the implant was put above or beneath the chest muscle. Unfortunately, most of these findings have not yet been reported, and the study is not yet published.

Implications for Patients and Women Considering Gel Implants

• The results of this study show that most women with silicone gel implants will have a broken implant within 10 years but they are unlikely to detect it unless they get an MRI.

• The study also indicates that estimates of rupture that are based on the women who have surgery to remove broken implants will grossly underestimate the problem. As a result of the many “silent ruptures,” implant patients and their surgeons have been unaware that most women will require repeated surgeries even if they do not have physical complaints about their implants.

• Even more worrisome, gel was migrating outside the scar capsule for more than one in every five women who were unaware that their implants were broken. This puts these women at risk for losing at least some of their own breast tissue when the implants are removed. In the most extreme cases, some of these women will need a mastectomy to remove the silicone, and the silicone could also migrate to the lungs or other vital organs.

All articles are reviewed and approved by Diana Zuckerman, PhD and senior staff.