The FDA recently updated its risk guidelines for breast implants. The move is aimed at ensuring that women considering breast implants have a clear picture of what implants involve before moving ahead with the surgery.
Amendments to the guidelines suggest that the FDA has taken note of a range of concerns around this lucrative aesthetic procedure.
Women must be aware of all the risks
Quoted in an article by Harvard Health, Dr. Andrea Pusic, the Joseph E. Murray Professor of Surgery at Harvard Medical School, explains that when a woman decides to get breast implants, she’s signing on for a long-term relationship.”Implants bring many benefits, both physical and psychological, whether a woman is choosing them for cosmetic reasons or for breast reconstruction in the wake of cancer surgery. But they also bring risks.”
“A woman who decides to have breast implants should know that they may not last forever. This means that she may need future surgery or have longer-term complications. Surgery is a serious decision, and devices aren’t perfect.” – Dr Andrea Pusic
What are the new breast implant guidelines, and why should you know about them?
- The FDA is establishing new labeling requirements for breast implant manufacturers, including a boxed warning.
- Allowing the sale of breast implants only to facilities that agree to provide patients with a comprehensive checklist outlining potential risks and benefits related to breast implants
- Updating screening recommendations designed to detect leaks in silicone breast implants
- Release updated information on breast implant post-approval studies to better inform patients.
The FDA changes are not new. Indeed, they were prompted by a panel of surgeons, scientists, women, and advocacy groups convened back in the spring of 2019.
Immediately following the meeting, the FDA moved to ban the sale of textured breast implants, which were linked to an elevated risk of a rare cancer called anaplastic large-cell lymphoma. Women with the implants were not advised to remove them, but were told to watch for breast changes.
What are the potential drawbacks associated with this procedure?
Another lesson learned from the meeting was that some women who have opted to get implants may have done so without clearly understanding all the potential drawbacks associated with the procedure.
The FDA’s order restricts the sale and distribution of breast implants to only health care providers and facilities that provide information to patients utilizing the patient brochure “Patient Decision Checklist.”
Patient decision checklist
The checklist must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits, and other information about the breast implant device. The patient must be given the opportunity to initial and sign the patient decision checklist, and it must be signed by the physician implanting the device.
Protecting patients
“Protecting patients’ health when they are treated with a medical device is our most important priority,” said Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “In recent years, the FDA has sought more ways to increase patient’s access to clear and understandable information about the benefits and risks of breast implants.
Better safety requirements for breast implants
By strengthening safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery. As the FDA continues to evaluate the overall effects of breast implants in patients, today’s actions help ensure that all patients receive the information they need to make well-informed decisions affecting their long-term, personal health.”
“Breast implants are not lifetime devices,” explains the FDA’s “What to Know About Breast Implants” website.
Monitoring problems from breast implants
In addition to requiring the checklist, the FDA changed its recommendations for screening women with silicone implants for leaks in an effort to encourage more women to get checked.
“Silicone implants were reintroduced in the United States in 2006,” says Dr. Pusic. They were taken off the market after issues arose around breast implants leaking, allowing the silicone to seep into the body.
Screening every two years if you have silicone implants will be a requirement in the US
To quickly identify and treat this problem before it becomes a health risk, the FDA recommends that women with silicone implants be screened for leaks every two years. Officials initially recommended that this be done using MRI. However, costs may be a barrier for many women, so ultrasound can also be used for routine surveillance, and potential problems confirmed using MRI.
Good news for women
The changes are good news for women, added Dr. Pusic. “Breast implant surgery has never been safer because the implant technology has improved, and leak rates are lower than ever. In addition, surgical complications are lower as well, thanks to new techniques and strategies. Now, women get some added assurance that the FDA is also actively engaged in making sure that breast implants are safe and that every woman is well informed,” she says.
Photo by philippe spitalier on Unsplash
Breast implants and inflammation
One of the growing concerns around breast implants has been inflammation, even low-grade inflammation.
According to the Harvard Medical School experts “Science has proven that chronic, low-grade inflammation can turn into a silent killer that contributes to cardiovascular disease, cancer, type 2 diabetes and other conditions. Get simple tips to fight inflammation and stay healthy.
Fatigue, depression, chest pain, and hair loss
One of the risks the panel focused on is breast implant illness, a collection of symptoms including fatigue, anxiety, depression, chest pain, and hair loss that some women believe are linked to their implants.
Longevity has published several articles on the issue, one of which included a first-hand real-life account. You can read more by clicking on this link: My Breast Implants Were Making Me Sick
“There is no question that a minority of women with breast implants are reporting symptoms. It’s not yet clear whether these symptoms are caused by breast implants or if they are caused by something else completely,” Dr. Pusic explained in the Harvard Health article.
“But researchers are trying to find out. In the meantime, the FDA wants women considering implant surgery to be aware that some women are experiencing these symptoms after the procedure.”
“The biggest takeaway is that we can do better in terms of informing patients about the risks and benefits of breast implants,” says Dr. Pusic.
What do breast implant illness survivors say?
Prior to the new guidelines being tabled, over a thousand women posted on the FDA website raising concerns.
As a Breast Implant Illness survivor, one of the most frustrating part for me is not knowing exactly what materials the implants are made of. Implants have destroyed my immune system to the point that I can no longer tolerate normal, everyday products, eat many foods, or come in contact with any chemicals without becoming seriously affected. The total lack of regulations, and the inaccurate information available, have left women with no other choice than to fend for themselves. It should NOT be like this.
Hundreds of thousands of women are not only suffering, but so are their families, children… and many women are unable to work and much of their healthcare is now at the expense of tax payer’s money. Not to mention the thousands of unnecessary tests which could all be avoided by holding manufacturers accountable.
Implants are destroying women’s health and lives by causing gene mutations, destroying immune systems, and more. Doctors also have to be held accountable and be fully aware of what they’re implanting into their patients, otherwise, they will continue to be part of the problem and not part of the solution, and further destroy more lives without any repercussions. How is that fair? The FDA keeps giving warnings and this is not enough. All of this is unfair, and this has been going on for decades. Follow through…Enough Is Enough, Now! Please do more. Thank you. Tracy Cee
Endnote
The updated FDA guidelines have been met with positive reports. However, and importantly, they must be fully supported and implemented by the medical profession who, after all, sit face to face with women who come for consultations looking for breast augmentation surgery.
If you’re considering breast implants, do your own research and make sure you are well informed. A useful resource is to also look at what women have posted on the FDA website, highlighting common issues experienced: https://www.regulations.gov/document/FDA-2019-D-4467-0001/comment
Photo credit
Main Photo by philippe spitalier on Unsplash
References
Harvard Health: https://www.health.harvard.edu/womens-health/fda-wants-women-to-understand-the-risks-and-benefits-related-to-breast-implants
FDA: Breast Implants
- https://www.fda.gov/consumers/consumer-updates/what-know-about-breast-implants
