All About the FDA’s Breast Implant Warnings

All About the FDA’s Breast Implant Warnings

By Amy Hammond

All About the FDA’s Breast Implant Warnings








All About the FDA’s Breast Implant Warnings

What Every Woman Considering Implant or Explant Needs to Know


In what can be described as one small step for the FDA and one giant leap for womankind, the regulatory agency released a recommendation in October of 2019 that warnings be included in breast implant packaging. Additionally, the agency urges surgeons to counsel women before they opt to undergo a breast augmentation operation. And those warnings? -They should be visible, not lost in easy-to-miss fine print.


To the women worldwide who have long been reporting mysterious symptoms they believed to be directly linked to their breast implants, the FDA’s admission is a huge victory. Anecdotal evidence of breast implant illness (BII) is pervasive and detailed, with women suffering from maladies such as brain fog, chronic fatigue, rapid heartbeat, infertility and more.


Lives have been altered as treatment for these symptoms proved elusive. Women underwent tests that came back with negative results and listened to medical professionals tell them ‘Nothing is wrong – it’s all in your head.’


“The problem is the implant itself; the body is not meant to house them,” says Akemi Fisher, founder of The Heal is Real, a nonprofit that aims to educate women globally about breast implant illness (BII).


Fisher herself suffered from breast implant illness for years before finally opting to have her breast implants removed. Her nonprofit exists to help others like her find the information they need in order to make an informed decision about implant and explant. She listened as woman after woman shared stories not unlike hers and decided to take action by forming a nonprofit.


“Women who visit can learn about breast augmentation procedures; they can decide for themselves whether they are a candidate for explant,” she says. “It’s a community that shares information and support.”


The recent FDA recommendations, Fisher says, are pivotal. During her own journey from augmentation to explant, she actually had to self-diagnose herself with breast implant illness because medical professionals were reluctant to do so. Explant brought with it subsequent recovery. She believes that the FDA’s recognition of breast implant risk is a large step in the right direction and should lead to the medical community’s recognition of breast implant illness.


What does the FDA recommendation directly mean?

It’s just that – a recommendation, not a mandate. If surgeons choose not to discuss the safety ramifications of breast implants with their patients, there will be no disciplinary action. If breast implant manufacturers opt not to include clear warning descriptions on packaging, fines will not be levied. While this may be seen by some as too lax, it is at least an inclination that the potential dangers of breast implants are now being taken seriously by the medical community. For the women who suffer from breast implant illness, this is a sign that their voices have been heard.


Another part of the recommendation involves a checklist that the FDA recommends a woman go through before opting for breast augmentation. The aim of this checklist is to ensure that patients understand that whether they opt for saline or silicone or gummy bear implants, they put themselves at risk for potential side effects. These can include scars, implant compromise (rupture) and even a cancer of the immune system.


Who is at risk for anaplastic large-cell lymphoma?

Currently, the only type of breast implant linked to anaplastic large-cell lymphoma is the textured implant; specifically, the Allergan BIOCELL textured implant and corresponding expanders. Textured implants ‘stick’ where they’re placed, offering a more natural look to the augmentation. They also pose a very direct threat; though the cancer is rare, it is directly related to the implants. The implants have been recalled, but the FDA is recommending explant only if a woman has symptoms.


“This does not make sense to me,” Fisher says. “The FDA wants a woman to wait until she has cancer to do something about these implants, while at the very least she may still develop breast implant disease and then anaplastic large-cell lymphoma.”


Fisher is a vocal advocate for explant. Her own breast implant illness symptoms of brain fog, back pain and more disappeared soon after her own implants were removed. It’s the gist of her message, after all, that ‘the heal is real’ – and that the healing can begin as soon as the implant is removed from a woman’s body.


That’s why, she says, the recent FDA recommendations and the recall of the Allergan BIOCELL implants are promising – but they’re not enough. She points to the prevalence of breast augmentation in the fitness and bodybuilding realm as an example. To be competitive, these athletes may feel the absolute need to augment through breast implants. In the 1998 book Women of Steel, sociologist and author Maria R. Lowe reported that 80% of competitors opted for augmentation. 


For the everywoman and the bodybuilding athlete alike, the allure of the ‘boob job’ is still high; The Heal is Real reports that 400,000 women undergo breast augmentation each year. Globally, 10 million women have breast implants. With numbers like these, it’s important, Fisher says, to spread the news that this operation is not without possible health ramifications.


Why are implants potentially dangerous?

According to the FDA, implants may result in serious side effects. These side effects occur for various reasons that include puncture, compromised implant, and issues with the capsule. Shortly after an implant is inserted during a breast augmentation procedure, a protective capsule forms around it. This is the body’s reaction to the foreign object that has been placed inside. The capsule, which is in essence scar tissue, can harden.


Puncture can release the contents of the implant into the human body – contents that were never meant to enter the bloodstream. Silicone in particular poses a threat in this situation. A manmade substance, silicone is described by the FDA as to not be used as a filler because of its possible determent to the body. When a silicone implant ruptures (breaks) the silicone can merge into the capsule and beyond. 


Even saline implants pose a risk if punctured. Fisher points to the many pictures on the Internet that women have posted after their explant surgery as an example of this. In these pictures, the breast implants appear mottled with mold and detritus. Saline implants can in fact harbor bacteria if they are punctured; if they are not removed expediently, this bacteria can adversely affect the body.


Then there’s the gummy bear implant, renowned for its ability to mimic the feel and appearance of a natural breast. If punctured, the gummy bear implant may leak slowly over time, sending silicone into the body undetected. An MRI is needed in order to expose the leak. Many women do not opt for those on a regular basis.


“Part of the problem is that breast implants are not meant to ‘live’ inside the human body for a lifetime,” Fisher says.


In fact, the ‘boob life’ of these implants varies depending on type and individual situation. Some need to be replaced after a few years; others can last a decade or more. Problems can arise even when women take heed of these ‘expiration dates,’ however. For some, breast implant illness strikes even when they’ve had a textbook augmentation. It did for Fisher.


“The actual breast augmentation surgery had nothing to do with my illness,” she says. “I recovered quickly and it was only when the implants had been in my body for months did I begin to feel symptoms.”


What do women need to know about their risk?

Those who are looking to undergo breast augmentation should fully understand the potential ramifications. This is what the FDA is asserting. Women should know the risks, which can include the need for additional surgeries at a later time (if the implant leaks or if a certain amount of time elapses), breast pain, anaplastic large-cell lymphoma and the myriad of symptoms exhibited by those who suffer from breast implant illness.


In the case of rupture, it is true that the silicone found inside breast implants is not considered injectable silicone, which has been deemed to harmful to be used as an injectable. However, there are many who believe that introducing any silicone to the body through the leakage of an implant can have possible adverse side effects. 


Women should read implant labels and inform themselves regarding the risks. They should also be on the lookout for symptoms and consult medical professionals expediently if adverse health effects occur. 


“The Heal is Real can help with this research,” says Fisher. “Our nonprofit is dedicated to spreading the message that breast implant illness is a real concern for those with implants, and it also serves as an educational resource for anyone considering implant or explant.”


Visit The Heal is Real at to read testimonials from women who have (or are currently experiencing) breast implant illness. The site also includes blogs about implants and their risks. Find resources regarding explant and discover what it’s like to have breast implants removed. Share your email to become a “Breastie” and receive up-to-date information about the latest in breast implant illness advocacy. It’s important, Fisher says, to be unified in the effort to spread the word that implants are not without risk. 


“The FDA’s recommendations are a win for those who suffer from breast implant illness,” Fisher says. “But the fight still continues.”