Tag Archives: breast implant illness

New Study Backs Breast Implant Illness Claims by Patients

Sasha Chavkin, International Consortium of Investigative Journalists: July 2, 2020


A new study in a leading plastic surgery journal offers more evidence to support the existence of breast implant illness, a malady reported by thousands of women but dismissed as scientifically unproven by many plastic surgeons and some health authorities.

The study focused on 750 women who complained of fatigue, memory loss, joint and muscle pain and other symptoms after having received breast implants. It found that as a group, the women experienced significant relief from their symptoms within 30 days of having their implants removed.

“The data speaks for itself,” said Dr. Lu-Jean Feng, a plastic surgeon and an author of the study. “It’s much more likely that the illness is due to breast implants if the improvements are within 30 days.”

The study adds to growing evidence that some women suffer systemic health problems after getting breast implants. It is well known that breast implants can lead to physical injuries such as rupture, leaking and painful tightening of scar tissue around the implant, known as capsular contracture. But many plastic surgeons have long contended that there is not enough scientific evidence to conclude that breast implants can cause health issues that affect the whole body, such as autoimmune disease and cognitive decline.

In 2018, the International Consortium of Investigative Journalists revealed that thousands of women around the world were suffering from serious illnesses after receiving breast implants as part of its Implant Files investigation.

Among the investigation’s findings were that an increasing number of studies indicated that breast implants were associated with systemic health effects such as autoimmune and connective tissue disease. These illnesses took a devastating toll on patients’ lives, often leaving them unable to work, struggling to maintain relationships and suffering severe pain.

The new study by Dr. Feng is not the first to show improvements in women’s health after they had their breast implants removed. But it has several notable elements: it has a relatively large sample size and it shows that major improvements occurred within 30 days of removal. In addition, all the patients were operated on by the same surgeon, Dr. Feng, using the same technique, eliminating the possibility that differences between doctors or methods influenced its results.

The women were surveyed before and after their breast implants were removed, and asked whether they suffered from 11 symptoms commonly associated with breast implant illness, including hair loss, joint pain, chronic fatigue and hives. Patients were asked to rate symptoms on a scale of zero to five. The mean preoperative score was 26.19; it dropped by nearly two thirds to 9.49, after removal.

The study was published in the Annals of Plastic Surgery, a peer-reviewed journal for plastic surgeons.

Diana Zuckerman, president of the health care policy think tank National Center for Health Research, said the publication was significant because it was a sign that the plastic surgery profession was beginning to accept the existence of breast implant illness.

“The plastic surgery journals have not been open to this kind of information,” Zuckerman said.

Breast implants are a crucial and lucrative product for plastic surgeons, and the breast implant business accounts for more than $1 billion in revenues each year.

The U.S. Food and Drug Administration has also shifted its stance on breast implant illness.

After long maintaining that there was insufficient evidence to connect breast implants and many symptoms reported by patients, the FDA now lists “Systemic symptoms Breast Implant Illness (BII)” among the risks and complications associated with breast implants, although it notes continuing scientific uncertainties.

“Symptoms such as fatigue, memory loss, rash, ‘brain fog,’ and joint pain may be associated with breast implants,” states the agency’s website.

Read the full article here

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 2018 1. 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/