Breast Implant Illness (BII)
Breast Implant Illness - No Medical Consensus, Plenty of Confusion
A History of Questionable Ethics
The confusion and controversy around the potential risks of breast implants is nothing new. Breast implants were first put on the market in the 60’s, before there were any formal regulations on medical devices. It wasn’t until 1976 that the FDA finally put the Medical Devices Amendment into effect.
But silicone breast implants had already been on the market for 15 years, so they were “grandfathered” in under the amendment, without any long-term research on their safety.
A year later, a Cleveland woman won a settlement for $170,000, after her breast implant ruptured, causing her illness and extreme pain. This was just the first of many legal battles that would follow, with more and more women claiming that their breast implants were making them sick.
Silicone breast implants were removed from the market in 1992 for safety concerns, and re-introduced in 2006, with greater regulations around warning labels on breast implant boxes, informed patient consent, and an FDA-required patient registry. That way, in the event that something was found wrong with a line of breast implants, the women who had them could be notified.
The Need for Long-term Studies
Manufacturers like Mentor and Sientra came under fire by the FDA for not providing sufficient follow-ups studies with their end-users. The companies claimed that it was hard to follow up when women often dropped out of studies, but the women in the studies reported the opposite.
“These post-approval studies were required by the FDA, but they’ve been flawed and incomplete and not reliable,” Jamee Cook said. “There’s been a failure to complete studies. Some women got lymphoma that would have been documented (if the studies had continued). Some women were told a study stopped or that the doctor had dropped out. Or, women were dropped after reporting symptoms. We’re missing data because of this.” (2)
Support for Women Experiencing BII Symptoms
While research has not proven any link between silicone and disease, there still have not been any longitudinal studies on if breasts implants can cause illness, even though they’ve been on the market for almost 50 years and more and more women are coming forward with their testimonies.
Now with social media allowing women to share their stories, there’s a growing movement demanding an investigation into the cluster of symptoms known as Breast Implant Illness (BII). BII isn’t a medically recognized diagnosis, but the symptoms and illnesses women are reporting are real.
Some people report chills, headaches, hair loss, rashes, fatigue, depression, chest pain, and the onset of chronic autoimmune disorders after having their breast implants for some time. A few studies have shown that a majority of women find relief from these symptoms when their implants are removed with an explant procedure, but again, there’s been a lack of long-term, well-designed studies on the subject.
If you’re considering getting breast implants or think you may be experiencing symptoms related to your implants, we recommend getting second (and third, and fourth) opinions, fully informing yourself, and reaching out to others for support.
Bōsm Wellness is here to support you on every stage of your breast health journey. We’re also here to educate women on the myriad issues that may impact breast health throughout their lifetime. It’s important that we create and find trusted sources of encouragement and information, when there is still so much negligence from the industries that are meant to inform and protect us.
With breast augmentation being the second most common cosmetic procedure, the manufacturers of breast implants stand to make a considerable profit by continuing their practices as is.
We’re curious - have you had issues with your breast implants? Or have you had no problems at all? How do you feel about the existing research on the topic? Let us know your experiences and stories in the comments below!
- Incollingo, Beth Fand. “FDA Demands More Information on Cancer and Illnesses Caused by Breast Implants.” Oncology Nursing News, 30 Mar. 2019, www.oncnursingnews.com/web-exclusives/fda-demands-more-information-on-cancer-and-illnesses-caused-by-breast-implants.
- Kelly, Erin. “The Bizarre And Terrifying History Of Breast Implants.” All That's Interesting, All That's Interesting, 8 Feb. 2018, allthatsinteresting.com/weird-history-of-breast-implants.