New Research Confirms Breast Implant Illness

Diana Zuckerman, Ph.D.


The biggest controversy regarding breast implants is whether and how often women with implants become sick with a pattern of symptoms that are known as breast implant illness. A study published in Annals of Plastic Surgery in July 2020 provides clear evidence that most women with these symptoms will recover dramatically if their implants and scar capsules are carefully removed by an experienced explant surgeon.

The study by Dr. Corinne Wee and her colleagues at University Hospitals Cleveland Medical Center compares 11 common breast implant illness symptoms of 750 women whose implants were explanted and not replaced in 2017 or 20181. Patients were asked to rate the 11 symptoms on a six-point scale (0-5, with 5 indicating “very severe”) at three times: prior to surgery, within 30 days after surgery, and during the following year. The symptoms included: numbness and tingling in the extremities; joint and/or muscle pain; hair loss; memory loss/cognitive problems; dry eyes and/or blurred vision; chronic fatigue; breast pain; rashes and/or hives; food sensitivity/intolerance; flu-like symptoms and/or low-grade fever; and difficulty breathing.  The average age of the implant at the time of explant was 12.6 years, and approximately half the women had saline implants and half had silicone gel implants.  Possible total scores for rating the symptoms ranged from 0 to 66; the average score prior to explant was 26.2 and within 30 days after explant was 9.5, which was a highly statistically significant improvement (p < .0001, which means that there is less than one chance in 10,000 that the improvement occurred by chance).  Although average scores on each of the 11 symptoms ranged from a low of 1.4 (for rashes and for flu) to a high of 3.5 (fatigue), each of the 11 symptoms also showed significant improvement at the .0001 level within 30 days.  When asked to rate their symptoms during the year after Day 30 (at a median of 138 days), the women’s improvement in symptoms was maintained but there was no additional improvement.

This study confirms similar results of a smaller study by De Boer and his colleagues published in 2016, which reviews and combines data from 23 studies, cases series, and case reports available at that time about the results of explanting breast implants “in patients with silicone-related complaints and/or autoimmune disease2.” These complaints (symptoms) included fatigue, myalgia, dry eyes, and memory and concentration disturbances.  Based on the research, the scientists calculated that 75% of the patients (469 of 622) had substantially improved symptoms when their implants were removed. However, the results were less promising for autoimmune diseases (such as Raynaud’s, IBS, and allergies); diseases improved only if the patients also received immunosuppressive therapy in addition to the explant surgery.

It also confirms our own research at the National Center for Health Research, not yet published, that shows dramatic improvement on these symptoms in a study of more than 300 women who had their implants removed.

It is important to know that almost 20 years ago, several studies conducted by government funded scientists were published in the scientific and medical literature indicating a statistically significant association with several connective tissue or autoimmune diseases or symptoms. Replication is the key to science; scientific literature usually builds on previous findings, or explains how they differ.  However, the studies that indicated possible risks of breast implants were generally ignored and eventually outnumbered by dozens of articles funded by implant companies or plastic surgeons, or both. None of the studies or either side of the controversy were focused on breast implants made by Mentor or any other specified company.

References

  1. Wee, C.E. Annals of Plastic Surgery: July 2020 – Volume 85 – Issue S1 – p S82-S86 https://journals.lww.com/annalsplasticsurgery/toc/2020/07001
  2. De Boer M, Colaris M, van der Hulst RR, Cohen Tervaert JW (2017) Is explantation of silicone breast implants useful in patients with complaints? Immunologic Research 65(1):25-36. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5406477/