National Center for Health Research: September 17, 2018.
A study published in September 2018 in the medical journal Annals of Surgery, entitled US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients, concluded that “silicone implants are associated with an increased risk of certain rare harms” and that further study is needed “to inform patient and surgeon decision-making.” The study is important because it is largest study to date, but it has limitations because it is based on data from flawed studies conducted by two implant companies, Mentor and Allergan.
The data collected from the two studies were supposed to be very similar, but because of how poorly the studies were conducted, they are not comparable. Mentor’s data are focused on patients’ self-reporting on questionnaires, primarily on data of only 20% of the patients collected 7 years after the study was started. Allergan’s data are based on physicians’ diagnoses during the first two years after the patients had implant surgery. Since patients’ self-reports at 7 years would be expected to include more complications than physicians’ diagnoses after 2 years, it is impossible to make meaningful comparisons between the two manufacturers. Nevertheless, it is important to note that the MD Anderson researchers found that the risks of certain autoimmune diseases increased by 800% (Sjogren syndrome), 700% (scleroderma), and 600% (arthritis) for the women with Mentor silicone gel breast implants compared to the general population of women of the same age and demographics. Stillbirths increased by 450% in the women who became pregnant. Other autoimmune and rare diseases were also significantly higher among women with Mentor silicone gel implants. These diagnoses were also statistically significantly higher (although not as dramatically increased) for women with Allergan implants compared to the general population of women of similar demographics. Given the large percentage of women who were not in the study for more than 1 year, it is not possible to know how representative these findings are. However, these results certainly deserve careful attention.
It is also important to note that the women with saline breast implants who were in the Mentor and Allergan studies were not analyzed in the MD Anderson study.
In response to this important study, Dr. Binita Ashar of the FDA published an editorial in the same issue of the same medical journal, claiming that the MD Anderson study “failed to account for methodologic differences between studies, inconsistencies in the data, differential loss to follow-up, confound and other potential sources of bias.” That is true. However, Dr. Ashar did not mention that the FDA should take responsibility for all the shortcomings of the data that MD Anderson analyzed. She did not mention that the flawed data were based on studies that were required by the FDA as a condition of approval for the breast implants made by Allergan and Mentor. The data were flawed because women soon disappeared from the study, and the FDA did not require the companies to finish the studies, as they should have,
As a result of the FDA’s failure to enforce the study requirements, the large Allergan and Mentor studies used as the basis of the MD Anderson analyses were very flawed short-term studies rather than the 10-year studies that FDA had proudly said they were requiring. Whereas the companies blamed the study shortcomings on the enormous number of women who “dropped out” of the study shortly after enrolling (including 80% of the women with Mentor implants after only 1 year), we have interviewed women who were enrolled in those studies who told us that they did not drop out of the studies – rather they were “dropped” from the study by the researchers without their consent. They never heard from the researchers and hence had no opportunity to tell the researchers how sick they had become after getting breast implants. Instead, several of those women went to the FDA this month to explain to FDA scientists what happened. They told Dr. Ashar and other FDA officials that they were dropped from the studies. They told Dr. Ashar and other FDA officials that they had suffered from autoimmune and connective tissue symptoms such as the ones reported in the MD Anderson study. They told Dr. Ashar and the other FDA officials that despite being sick for years, they were unaware that breast implants could be the cause because neither the FDA nor their plastic surgeons had warned them of the risks. When they finally found each other on social media (on Facebook pages joined by more than 50,000 women harmed by breast implants), they realized that removing their implants might help. Much to their surprise, they experienced almost miraculous recoveries after their implants were removed by experienced explant surgeons. The women told Dr. Ashar and other FDA officials that their symptoms disappeared entirely or improved by 85%.
The FDA editorial was written before Dr. Ashar met with the former implant patients this month, but she had previously met with several of the same women who had reported these same problems and recoveries after explant surgery. So it is very discouraging that FDA staff have been and continue to be so close-minded about the risk of breast implants despite the MD Anderson analyses.
What Have we Learned from the MD Anderson Study?
We agree with the FDA and the MD Anderson researchers that these results can’t be considered conclusive, but the FDA needs to look at the data more carefully and require better studies so that they can reconsider their repeated claim that breast implants are only proven to cause local complications, such as leaking and painful implants. Although the FDA admits that breast implants can cause a cancer of the immune system known as ALCL, they continue to quote industry-funded studies claiming that implants do not cause other systemic illnesses. It should be obvious to open-minded scientists that if breast implants can cause cancer of the immune system, they can probably cause other serious immune system diseases and symptoms. Moreover, the results of the MD Anderson study supports those concerns about autoimmune symptoms and diseases.
What should be the key information of importance to women considering breast implants or women who have them in their bodies? Clearly, these studies indicate that patients should report any new symptoms that develop after getting their implants, whether involving their breasts or other parts of their body. Breast implant patients should know that the FDA recommends MRI imaging of silicone breast implants 3 years after the augmentation or reconstructive surgery and every 2 years thereafter.