Cancer Prevention and Treatment Fund
Women with breast cancer often choose mastectomy because they don’t want to ever have to think about the cancer again. Unfortunately, the latest research shows that if they get reconstruction with silicone gel implants, they are likely to have many complications and need additional surgery.
Everyone agrees that breast implants are not lifelong devices. In fact, about half of reconstruction patients have their implants 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 79% of their patients. In comparison, Allergan lost track of just over 25% of their reconstruction 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 patients 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 few “Core studies” 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 98 reconstruction patients who got implants for the first time.
Within 4 years, 41% 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 four patients had at least one implant removed. Other common complications included breast pain, infections, and swelling.
Within 10 years, 72% of the women underwent at least one additional operation to correct implant problems and 54% had at least one implant removed. One in four had serious capsular contracture and 23% complained of asymmetry. Other complications, such as breast pain, ranged up to 7% each. However, 27% of the implants were ruptured, affecting approximately half the women. The number of women affected by ruptured implants is much higher than the percentage of implants ruptured, because most women have two implants (but only rarely do both implants rupture at the same time).
The Mentor Core Study followed 251 reconstruction patients.
After 3 years, 27% had another operation to fix and implant problem (for the same reasons as listed above). Almost 13% had an implant removed. One in ten had serious capsular contracture and up to 7% reported other complications such as asymmetry.
Within 8 years, 39% had another operation to fix an implant problem and 23% had an implant removed. More than one in seven suffered from serious capsular contracture. However, 14% of the implants were ruptured, affecting approximately one in four women.
Why are the complication rates less high for Mentor? There are a few problems with the Mentor statistics. For example, some common complications, such as asymmetry, are not reported for the cumulative 8 year data. Also, Mentor complications were reported at 3 and 8 years, compared to 4 and 10 years for Allergan. In addition, Mentor lost more women to follow-up in their study. Those that had problems may have been more likely to drop out of the study or be dropped from the study when their implants were removed.
|Common Complications||4 years(98 patients)||10 years(44 patients)||3 years(251 patients)||8 years(151 patients)|
|Capsular contracture (III/IV)||14%||25%||9%||15%|