2011 FDA Update on Silicone Gel Breast Implant Safety: Many Unanswered Questions

Diana Zuckerman, PhD and Judith Avory Faucette, JD

The FDA released a new report entitled Update on the Safety of Silicone Gel-Filled Breast Implants on June 22, 2011.  The FDA summarized the report as showing that breast implants cause many complications and often need to be removed, but that if “used as directed” (including regular MRIs) implants are “reasonably safe.”  However, the FDA admits that we don’t have as much safety information as we need, and that the implant companies haven’t done a very good job of doing safety studies.

After reviewing the research, we conclude that most of the studies that were conducted by Mentor (Johnson & Johnson) and Allergan are completely inadequate to provide safety information to patients.  These studies of 40,000 women for each manufacturer’s study were required as a condition of the approval of silicone gel breast implants in 2006.  The goal was for the FDA, patients, and doctors to find out more about the risks of silicone gel breast implants over time.  They were intentionally large so that the risks of relatively rare complications, such as autoimmune diseases, could be evaluated. Several years into the studies, most of the patients have dropped out.  Only about half of the Allergan augmentation patients stayed in their studies, and most of the Mentor augmentation and reconstruction patients dropped out of the studies. As a result, the studies cannot provide meaningful information about safety for those patients.

Why Can’t the Studies Provide Meaningful Information About Breast Implant Safety?

There are three major problems with the breast implant studies submitted to the FDA.

#1. Most studies lost track of most patients, so that the results can’t tell us what “most women” will experience. The complication rate for “most women” could be much higher or much lower.

#2. Most of the studies didn’t ask patients about the kinds of health problems that many women with implants experience. And, the studies stop at 10 years, whereas many of the worst complications occur after more than 10 years.

#3. Some of the studies rely primarily on questionnaires filled out by the patients, rather than medical records or medical examinations. In medical research, medical examinations or medical records are considered much more accurate ways to evaluate a person’s health than questionnaires.

The FDA report includes several studies that the companies conducted and submitted as a requirement of FDA approval.  The FDA has not stated how many of the studies relied on information from medical examinations and how many relied on questionnaires filled out by the patients. However, we know that the largest studies, which should be the most important ones, rely on questionnaires. The “Core” studies of breast implants have some good 8-10 year information about local complications (such as implant breakage) for breast cancer patients but very limited information about augmentation patients. Information is especially lacking for women with Mentor implants.

Studies that are called the “Adjunct studies” lost track of most of their patients and can’t provide useful information about complications of any type.

The Patients Did Not Stay in the Studies

The largest studies–the ones with more than 40,000 patients each conducted by Mentor and Allergan—have reported the first two or three years of data. Mentor already lost track of 79% of all their patients after three years. Allergan lost track of almost half their augmentation patients in their first two years, and 25-31% of their reconstruction patients in the first two years. These studies are supposed to continue for 10 years.  Usually, if patients drop out of a study after 2 or 3 years, they won’t participate in the study after that. For that reason, a study that lost even 25% of their patients after only 2 years are likely to lose more than half by 5 years, and the majority by 10 years.

When even a third to a half of the patients drop out before the research is completed, it is impossible to say with confidence what percentage of women will need additional surgery or have health problems after getting breast implants. In research, this problem is called missing data or “loss to follow-up.”  In most of the studies that the companies conducted, most of the patients did not provide follow-up health information in the years that the study was supposed to measure complications. Did the companies lose track of the patients because the patients no longer stayed in touch with their plastic surgeon? Did patients stop going to the doctor because their implants were removed?  Were they “lost to follow-up” because they died or got very sick?  Or are they 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?  The huge number of patients who are “missing” from many of these studies, and especially the Mentor studies, are such a problem that these results would not be publishable in any peer-reviewed journal.

Is the Safety Information Provided Accurate and Comprehensive?

Some women have told us that when they reported health problems to their plastic surgeons, those problems were not reported to the FDA as part of the studies.  We don’t know how often this happens, but complications would be under-counted whenever that happens.  Patients tell us that plastic surgeons have an interest in staying in touch when the patients are satisfied, but not when patients are having problems. This could result in many women with implant problems being “lost to follow-up,” and those health problems would therefore not be counted in the study results.

Another problem with these largest studies is that they rely on questionnaires that patients fill out online for payment. A patient that wants to receive the payment ($10 or $20) might fill out the questionnaire very quickly, and not necessarily carefully. And, even if the patient does her best to fill out the questionnaire accurately, she may not know the answers to some of the questions about diagnoses of a long list of diseases, most of which the patient may never have heard of and some of which are almost impossible to pronounce.

In addition, It seems that some of the studies did did not ask about many of the complications that women with leaking implants have complained about in testimony before the FDA, such as joint pain, hair loss, and other autoimmune symptoms. By focusing on the diagnosis of rare diseases rather than on symptoms that are more likely, some of the studies seem designed to result in an “implants are safe” conclusion rather than a “complications can be devastating “ conclusion.

Despite these shortcomings, the FDA concluded that the studies show that many women with implants have “frequent local complications and adverse outcomes.” However, the results could have been very different if the studies did not have the three major flaws listed above.

What Do these Studies Tell Us about the FDA Post-Market Policies and Safety Data?

Once a medical product is approved, its manufacturers have no incentive to do required post-market studies properly.  Silicone breast implants are just one example of how the FDA’s reliance on post-market studies to determine product safety can lead to inadequate safety data that have no practical value for a patient trying to decide whether to use a medical product.  Most women considering silicone breast implants can have no way of knowing how likely they are to experience serious complications when studies are so poorly conducted.

What should the FDA do differently?  It’s time for the FDA to acknowledge that studies done before approval are likely to be much better than the ones done afterwards.  The FDA should require better information before approving a product, and should rescind approval if a company fails to provide adequate safety data after approval.

What Do Women Considering Breast Implants Need to Know about Implant Safety?

The FDA reminds us in this report that “breast implants are not lifelong devices.”  Many patients need additional surgery and perhaps need to have their implants removed within a few years.  They report that about half the reconstruction patients (those who get implants after cancer or trauma) need to have their implants removed within 8-10 years.  The FDA reported lower rates of removal (1 in 5 patients) in 8-10 years for augmentation patients, but are those lower numbers credible?  We think that they are not credible because so many of the augmentation patients were not in the study after 8-10 years.  We don’t even know if the women whose implants were removed were intentionally dropped from the study because they no longer had breast implants.

The FDA report also reminds us that breast implant complications are common.  “The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), re-operation (additional surgeries) and implant removal.  Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.”  If a silicone gel implant leaks or ruptures, the silicone gel can migrate to the lymph modes or organs where it can’t be surgically removed.

The FDA notes that “preliminary data” does not show a link between breast implants and autoimmune or connective tissue disease.  ”However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer than those conducted thus far,” the FDA admits.  Although the FDA did not mention it, research indicates that autoimmune problems often decrease after breast implants are removed.

We recommend that women considering implants always make sure they have at least $6,000-$8,000 saved to remove problem implants, in addition to the cost of the initial surgery.  The FDA cautions women to “assume that you will need to have additional surgeries.”  We have heard from many women who had serious health problems and were unable to remove their implants because they did not have enough money for surgery.  While breast augmentation surgery is sometimes available on an installment plan, implant removal surgery is not.

Women considering implants can follow the link to read more information about breast implant safety.

What Do Women Who Have Silicone Gel Breast Implants Need to Know?

The FDA reminds women with silicone gel breast implants to get an MRI three years after getting their implants, and every other year after that.  The FDA warns, however that this procedure “is costly and may not be covered by your insurance.”

The FDA also tells women that “The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications.”

The FDA states that “Preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis.  However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer than those conducted thus far.”

“At this time, the FDA is recommending that health care professionals and women who have silicone gel-filled breast implants do the following:

  • Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture.
  • Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring and infection.
  • Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online at http://www.fda.gov/Safety/MedWatch/default.htm or by calling 800-332-1088.
  • Stay in touch. If a woman has enrolled in a manufacturer-sponsored post-approval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.”

Women with silicone gel breast implants can follow the links to read more about silicone breast implant problems and what to do if your implant breaks.