UPDATE 2011: Are Silicone Breast Implants Safe?

Women who consider breast implants often think of them as a one-time investment in their appearance.  Unfortunately, the latest research shows that if they get silicone gel implants, they are likely to have many complications and will need numerous additional surgeries.

Everyone agrees that breast implants are not lifelong devices.  In fact, about one in four women have at least one implant removed within 8-10 years.  Even more women have leaking implants or other problems that require removal, but are reluctant to undergo surgery again.  Those women were not counted by the companies that did the research.

There are two manufacturers that make breast implants in the U.S, and both got FDA approval to sell their silicone implants on the condition that they conduct 10-year studies on more than 40,000 women with implants.  One company, Mentor, is doing a very poor job and that is why in August 2011 consumer advocates and public health experts asked the FDA to rescind approval of Mentor silicone gel breast implants. Mentor started their study of 40,000 women but within 3 years they lost track of more than 80% of their augmentation patients.  In comparison, Allergan lost track of almost half of their augmentation patients in the first two years.

When so many patients drop out of a study, it raises a lot of questions. Did the companies lose track of the patients because the patients did not stay in touch with their surgeon?  Did patients stop going to the doctor because their implants were removed?  Did they drop out of the study because they died or got very sick, or because they were so happy with their implants and their lives that they didn’t want to be bothered going back to the plastic surgeon or filling out questionnaires? Patients tell our organization that plastic surgeons are very enthusiastic about staying in touch with patients who are satisfied, but not with patients who are having problems. Some patients report being “fired” by their doctors, who let them know they are no longer welcome! When that happens, the research findings are biased and don’t provide accurate information about safety.

Another problem with the studies is that most did not ask about many of the complications that women with leaking implants tell us about.  For example, in August 2011, women who got their breast implants in the last few years told the FDA that they suffered from joint pain, hair loss, memory loss, and other autoimmune symptoms.  Instead, the studies asked women if they had been diagnosed with rare diseases or other types of cancer. Most women with implants assumed that the joint pain, memory loss, and fatigue they experience are from getting older, but when their implants were removed they felt younger and healthier than they had in years.

The huge number of women who “dropped out” of these studies, and especially the Mentor studies, are such a problem that these results would not be publishable in any peer-reviewed journal. If a company can’t provide solid scientific evidence that their implants are safe for long-term use, we believe they should not be allowed to sell them in the U.S.

More Surgery and Other Problems from Implants

So what does the newest research data show?   Only the better studies can tell us anything about safety, so we relied on only the Allergan “Core study” as the only study of augmentation patients where at least 60% of the patients were followed up for at least 8 years.  However, if women were taken out of the studies when their implants were removed, these complication rates are lower than they really were.

The Allergan Core Study followed 455 augmentation patients who got implants for the first time.

Within 4 years, 24% had another operation to fix an implant problem.  The most common complications and reasons for reoperation were dissatisfaction with how they looked, capsular contracture (painful hardening of the breast), hematoma (build-up of blood outside a blood vessel), or seroma (build-up of liquid). One in ten patients had at least one implant removed. Other common complications included loss of sensation in the nipples, breast pain, and swelling.

Within 10 years, 36% of the women underwent at least one additional operation to correct implant problems and 21% had at least one implant removedOne in five had serious capsular contracture and one in ten complained of breast pain. Most other  complications were appearance, such as asymmetry and the implant moving to the wrong position.  However, 10% of the implants were ruptured, affecting approximately 20% of the women. The number of women affected by ruptured implants is about twice the percentage of implants ruptured, because all the women have two implants (but only rarely do both implants rupture at the same time).

The Mentor Core Study followed 551 augmentation patients.  We will not report the complication rates because too many of the women (almost half) did not complete 8 years in the study.  In addition, some common complications, such as asymmetry, are not reported for the cumulative 8-year data.  Those that had implant problems may have been more likely to drop out of the study or be dropped from the study when their implants were removed.   That makes the results meaningless as a way to evaluate safety for all augmentation patients with Mentor implants.

Allergan

Common Complications

4 years

(98 patients)

10 years

(44 patients)

Reoperation 24% 36%
Removal/replacement 10% 21%
Capsular contracture III/IV 13% 19%
Breast pain 8% 11%

Swelling

8%

9%

Nipple Complications 5% 6%
Scarring 4% 4%
Asymmetry 3% 3%
Seroma 1% 2%