For decades, thousands of women have reported that their breast implants were making them sick. Now, Michelle Visage has teamed with WOW Docs to shine a light on women like her whose drastic solution to Breast Implant Illness (BII) is to get their implants removed. Take a deep dive into the subject below, then watch Explant now on Paramount+. Note: the trailer includes medical images of breasts and may be NSFW.

Background

Silicone-filled breast implants were invented in 1962 and implanted for over a quarter century before FDA reclassified them in 1988 and required more detailed reporting on side effects and failures.

In 1992, FDA placed a moratorium on all silicone gel implants in the US, but they allowed saline implants to be used instead. Many patients are not aware that breast implants are not considered lifetime devices. Most manufacturers suggest replacing them with additional surgery over a set time period.

Breast implants are considered medical devices by the US Food and Drug Administration (FDA). FDA collects medical device reports (MDRs) on all adverse effects related to regulated devices. These reports are called “event narratives.”

Activists prompt government action

After decades of activism by women like Michelle Visage, FDA finally conducted a query of the MDR database for all reports posted between January 1, 2008 and October 31, 2019 referring to a saline- or silicone-filled breast prosthesis whose event narrative included about 100 illness keywords and one or more of the following terms or phrases:

• BII
• Breast implant illness
• Generalized/unexplained illness
• Unexplained systemic symptoms

The results were eye-opening:

Of the 3,577 MDRs, 1535 (or 43%) reported the patient undergoing device explant at some time following the onset of symptoms. Of these, 1,473 reports provided information sufficient to calculate the time from implantation to explant. The average time to explant was 9 years, with a range of 0- 47 years. Only 290 MDRs provided information related to the status of a woman’s symptoms following explant. Of these, 279 noted improvement and 11 noted either no improvement or worsening of symptoms.

The top adverse effects reported were:

• Fatigue (49% of respondents)
• “Brain Fog” (25%)
• Joint Pain (25%)
• Anxiety (24%)
• Hair Loss (21%)
• Depression (19%)
• Rash (18%)
• Autoimmune Diseases (18%)
• Inflammation (18%)
• Weight Fluctuation (18%)

FDA continues to classify breast implants as Generally Recognized As Safe (GRAS), and professional medical associations continue to question the validity of these claims. However, in 2020, they issued further findings on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of cancer of the immune system. FDA found that this adverse effect was most likely in women whose implants had a textured shell, with the majority of cases associated with the manufacturer Allergan:

Specifically, of the 733 total unique cases of BIA-ALCL reported to FDA, 620 cases were reported for Allergan implants, and 47 cases involved implants with an unknown manufacturer. With respect to implant surface for the 733 total unique cases of BIA-ALCL, 496 cases were reported to have textured implants, and 209 cases did not specify the implant surface. Of the 36 total patient deaths reported to FDA, 15 of the 16 patients for which the manufacturer of the implant is known, are reported to have had an Allergan breast implant at the time of their BIA-ALCL diagnosis. In terms of implant surface, of the 36 cases reported of patient deaths, 16 cases reported textured implants, and 19 cases did not contain information on the implant surface.

Thanks to the work by activists, major plastic surgery associations have partnered with FDA to study this condition, creating the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE). FDA encourages encourages but does not require PROFILE reports to understand the role of breast implants in ALCL and the management of this disease.

Dr. Diana Zuckerman, president of the National Center for Health Research, says:

BII is a cluster of symptoms that don’t fit into any other classic disease diagnosis. We believe that it eventually will be recognized as a medical condition, but that process will take time.

Below is a short clip where Ru and Michelle talk about her decision to have her implants removed:

What’s next

This controversy is obviously far from over. Michelle spoke candidly to RuPaul about her experiences in 2019, but that conversation only scratches the surface of the controversy.

For an in-depth discussion of the subject as told by medical professionals and the women whose harrowing first-hand experiences prompted them to remove their implants, watch Explant, available now on Paramount+.

As someone with breast implants and several ailments others have associated with their implants, I found this documentary shocking and compelling. I will follow up on the developments after this exposé airs. Thanks to director Jeremy Simmons and WOW cofounders Randy Barbato and Fenton Bailey for shining a light on this important issue. And most of all, thank you to Michelle Visage and David Case for being leading voices in this matter. Women are often not believed, especially when reporting medical matters. Only through speaking out will we get to the answers that will help others!

Image: YouTube / WOWPresents