The U.S. Food and Drug Administration (FDA) is urging doctors, plastic surgeons, and breast implant manufacturers to do a better job warning patients about the risks associated with breast implants. Over 300,000 women in the U.S. get breast implants each year, many of whom are patients with breast cancer who choose breast reconstruction after mastectomy.
According to Dr. Andrea Pusic, Chief of Plastic and Reconstructive Surgery at Brigham and Women’s Hospital, these recommendations shouldn’t be taken to mean that implants are unsafe. “The vast majority of women who have breast implant surgery, whether it be for cosmetic reasons or for reconstruction after breast cancer surgery, do really well with their implants,” Dr. Pusic told SurvivorNet. But complications can occur in rare cases, and the FDA wants women to know these risks.Read More
- Include a boxed warning on all silicone and saline breast implants
- Give patients a decision checklist laying out the risks before they commit to breast implants
- Provide anyone considering breast implants with materials and device descriptions, including “types and quantities of chemicals and heavy metals found in or released by breast implants”
- Make sure patients are aware and informed of silicone gel-filled breast implant rupture screening recommendations (that is, the recommendations about getting checked periodically to ensure implants have not ruptured)
- Give every patient who gets implants a “patient device card” laying out important information about their specific type of implant
Dr. Pusic told SurvivorNet that, in her experience, many plastic surgeons are already laying out these warnings to patients, but that she sees the FDA guidance a way to strengthen and standardize those warnings.
“The FDA is really trying to help make sure that women know as much information as we [providers] do about the risks of breast implants and that they’re able to process that and make a good decision themselves,” Dr. Pusic said, explaining that she doesn’t want anyone to misinterpret this news to mean that breast implants overall “aren’t safe.”
Dr. Alyssa Golas, a plastic surgeon at NYU Langone Health who specializes in breast reconstruction, added that “while the new FDA Draft Guidelines are helpful to clearly delineate these risks, a detailed discussion of these points should already be a part of the informed consent process.”
What About the Cancer Risk?
The FDA guidance does come just months after one (less common) type of breast implant — the textured kind — was found to be linked to a rare kind of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The cancer link resulted in the manufacturing company that makes the textured implants, Allergen, Inc., recalling the products worldwide.
But it’s really important to keep in mind that the majority of women who get breast implants, however, do not get the textured kind linked to cancer. The “smooth” implants, which are usually filled with either saline or silicone, are the more common choice. Unlike the textured implants, the smooth ones have not been linked to cancer. But according to the FDA guidance, women who get the more common smooth implants should be aware of different potential complications reported in the past, including:
- Joint paint
- Muscle aches
- Chronic fatigue
- Autoimmune diseases
It’s Not Clear Yet Whether the Breast Implants Actually Caused These Symptoms — But Women Still Deserve to Know About Them
The FDA did say that more research is needed to determine the individual risk factors for each of these symptoms (referred to as “breast implant illness”). And as Dr. Pusic pointed out, there isn’t sufficient evidence yet to say that, in women who experienced breast implant illness, the symptoms were actually caused by the implants. “This is something that we’re actively investigating from an American Society of Plastic Surgeons (ASPS) perspective, trying to understand both the symptoms that women are recording and whether they have any association with the implants,” Dr. Pusic, who has been in various leadership roles at the ASPC, said. “There’s a lot [of research] to be done there still. So what the FDA is saying is that it’s possible that [people who get implants] might experience these symptoms, but we don’t know yet whether they might be associated with their implants. I think that’s completely appropriate.”
In order to better asses, the risks and complications going forward — and to sufficiently prove that these symptoms are linked to breast implants — Dr. Pusic said it’s really important for women who get implants to join the National Breast Implant Registry, a collaboration between the Plastic Surgery Foundation and the FDA. The registry allows researchers to collect data about symptoms, outcomes, and risks associated with implants.
“The use of any foreign object in the human body has potential risks, Dr. Dung Nguyen, Director of Breast Reconstruction at Stanford Medicine, told SurvivorNet. “Some are rare and are not known until years after they are in clinical use. It is our professional responsibility to inform our patients of these risks and any changes to them as our experience with the device broadens. The goal is not to cause a mass scare, but to provide evidence-based information in a relatable way so that women can make educated decisions about the use of breast implants for themselves.”
Know Your Options -- Breast Reconstruction After Mastectomy
- Breast Reconstruction: Implants vs. Your Own Tissue
- Breast Reconstruction: Regaining Your Sense of Self
- Implant Reconstruction After a Mastectomy: The Options
- The Flat Movement: Embracing Your Body After Treatment
- New Worldwide Recall for Textured Breast Implants — What Women Who Have Them Should Know About Their Cancer Risk
- The Silver Linings: Laura Morton On The Aftermath Of Breast Cancer Surgery
Know the Risks, Weigh the Benefits
“The last thing women with breast cancer need is another thing to worry about,” Dr. Pusic said, explaining that she doesn’t want people with implants — especially her patients with breast cancer — to interpret the FDA’s guidance to mean that breast implants are unsafe.
“The thing that we have to keep in mind is that there are like hundreds of thousands of women who have had breast implant surgery without any of these symptoms,” Dr. Pusic said. “These are women who have only benefitted from their surgeries, and I wouldn’t want women taking this out of context and saying, ‘Oh breast implants aren’t safe anymore,’ or ‘something’s changed.”
Yes, there are women who do experience complications like leaking or scar tissue forming (or in rare cases, cancer linked to textured implants). Women considering implants should be made aware of these risks. But as Dr. Pusic told us, “As with any kind of surgery or anything that happens in life, we weigh the risks and benefits. My whole world is about breast cancer reconstruction, so I know first-hand as a doctor that when a woman has a mastectomy and she chooses implant reconstruction, that decision can be very good for her — for restoring body image, quality of life, just being able to wear a bathing suit and not be self-conscious, or being physically active and not being worried about prosthesis. With the release of this guideline, [it’s important] that we don’t lose sight of the fact that there are also important benefits.”