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Q&A: FDA answers questions on new warning for breast Implants

The FDA is now requiring manufactures to label breast implants with a boxed warning indicating...
The FDA is now requiring manufactures to label breast implants with a boxed warning indicating the risk of serious injury or death.(Arizona's Family)
Updated: Oct. 30, 2021 at 6:00 AM MST
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PHOENIX (3TV/CBS 5) - After decades of being ignored by doctors and the government, women who claim breast implants made them sick scored a major victory. The FDA is now requiring manufacturers to label breast implants with a boxed warning, indicating the risk of serious injury or death.

Women with breast implants describe suffering from a wide range of symptoms including extreme fatigue, rash, brain fog, memory issues, joint and muscle pain, autoimmune disorders, anxiety, light sensitivity, problems breathing, and the list goes on. These symptoms have come to be known as Breast Implant Illness.

New labeling and sales restrictions announced by the FDA include:

  • A box warning
  • Patient decision checklist
  • Updated recommendations regarding screening for silent silicone gel-filled breast implant rupture
  • Device description with a list of the specific materials used in the device
  • Patient device card
  • Restrictions on the sale and distribution of the breast implant, ensuring that patients considering breast implants are provided with the patient decision checklist information so that they can make a fully informed decision. Both the patient and the implanting physician are to sign that checklist.

Dr. Binita Ashar, Director of the Office of Surgical and Infection Control Devices, heads up the FDA’s team investigating claims that breast implants are linked to health problems.

Arizona’s Family Investigative reporter Kris Pickel spoke with Dr. Ashar and FDA spokesperson Audra Harrison regarding these new warnings. Below is their question and answer session. The text has been modified for formatting.

Pickel: “What exactly is the FDA requiring?”

Dr. Ashar: “The actions being taken include restricting the sale and distribution of breast implants and improved labeling. This is to encourage greater conversations between patients and physicians about the risks and benefits of breast implants. We’ve had discussions with patients and healthcare providers for a while and we agree that more can be done to better inform patients about the risks and benefits of breast implants.”

Pickel: “How will this be enforced to make sure patients get the checklist?”

Dr. Ashar: “We’re going to be working with manufacturers to assure there is an approach in place to assure their compliance.”

Pickel: “What does the FDA feel will be the biggest benefit of the boxed warning?”

Dr. Ashar: “Every patient needs to know about risks. What we have learned is these risks are not always discussed. Every patient needs to know that breast implants are not lifetime devices. The longer a woman has implants, the more likely they are to experience complications, some of which require reoperation. All patients need to know about the risk of BIA-ALCL. While BIA-ALCL is treatable, some patients have died.”

[Note: BIA-ALCL stands for Breast Implant Associated-Anaplastic Large Cell Lymphoma. BIA-ALCL is a cancer of the immune system and develops in the scar tissue around the implant.]

Dr. Ashar: “All patients need to know that there are patients that report a variety of systemic symptoms referred to as Breast Implant Illness. In those patients, many times, the removal of the breast implant has actually reversed the situation. The patient decision checklist goes into more detail.”

  • Click here to see the Guidance Document released in September 2020. The patient decision checklist is included.

Pickel: “Is this an acknowledgment that breast implants can make some women sick?”

Dr. Ashar: “We believe patients that have breast implants are reporting systemic symptoms. We don’t understand what’s occurring in these patients. We need to continue studying that. Not having a complete understanding of what is causing the symptoms is part of the boxed warning. Patients can digest the information to decide if, under those circumstances, implants are right for them.”

Pickel: “The boxed warning is a label that is put on the packaging. Typically, only doctors see the packaging. What steps will be taken to ensure the boxed warning is seen by patients?”

Dr. Ashar: “That information is included in the patient brochure and the patient decision checklist. The checklist goes into more detail about each of the items in the boxed warning.”

Pickel: “A lot of doctors don’t take into consideration that breast implants may be connected to a woman’s symptoms. What kind of changes should this bring about in the medical profession overall?”

Dr. Ashar: “There’s always more that we can do. I think this is an important first step. This is going to be required in order for health care facilities and providers to receive breast implants to implant in their patients. So the first step is the patient’s decision checklist. It includes much of this information that we want to broadly disseminate. We’ll continue to work on it, but we’ve been at it for a while and we’re going to continue to stay at it.”

Pickel: “But what message does it send to the medical profession when it comes to looking at breast implants as a source of illness?”

Dr. Ashar: “We are all collectively wanting our patients to have great outcomes. Part of that is making sure the patient is fully informed about the benefits and risks and that the provider is also aware. Every patient wants to know, ‘what am I in for?’. This facilitates that discussion. What we want is a collective understanding of the risks and benefits so that patients can choose whether to have breast implants with a better understanding of the commitment associated with them.”

Pickel: “It does sound like you’re acknowledging breast implant illness so should this be a larger message to the medical profession that they need to look at breast implants as a possible source if a woman is ill?”

Dr. Ashar: “We haven’t made any specific recommendations on how to work up a patient, but how could these new warnings help? I think if a patient has a rheumatological disease and is contemplating breast implants, she may want to look at the boxed warning and understand these sorts of symptoms have been reported in patients with breast implants and make an appropriate decision for herself. We continue to work to better understand breast implants. There’s definitely more research that needs to be done. That’s why we’ve invested a lot of effort in creating two long-term registries including The PROFILE Registry and the National Breast Implant Registry. It’s our hope, with long-term follow-up on patients, we’ll understand why they’re having their breast implants removed and be able to trace the reasons. I think it’s an awareness that needs to occur and further study is definitely required.”

Pickel: “Should this open the door for insurance companies to cover the cost of removing breast implants if a woman is sick?”

Audra Harrison: “I think that might be a little bit out of our lane, but Binita, I’ll defer to you.”

Dr. Ashar: “We do include in the patient decision checklist information indicating some of the costs associated with MRIs or workups might not be covered so the patient is informed. That’s the extent of it because our agency is not involved in those decisions regarding coverage.”

Pickel: “Can you explain the significance of a boxed warning?”

Dr. Ashar: “The boxed warning is prominently displayed. It’s easy to understand. It’s intended to highlight key things that patients should know. I would encourage patients not to stop at the boxed warning. Every patient contemplating breast implants should take a look at the patient’s decision checklist, even patients who have breast implants. I think it would be helpful for them to review the checklist.”

Pickel: “Is the boxed warning going to be the same wording in the draft guidance the FDA issued in September 2020? There is criticism that it wasn’t strong enough when it comes to breast implant illness.”

Dr. Ashar: “Yes. I believe we received over 2,000 comments on the guidance document. I am very proud of the work that our team at FDA did putting this together. I think it’s full of information with the boxed warning and patient decision checklist. This is a big step forward and we will continue working at this. We’re continuously talking to patient groups and other stakeholders. We are integrating that feedback to provide the best recommendations possible so our website and the materials we issue are helpful to patients.”

Pickel: “What will happen to doctors or surgeons who give these checklists to patients but say, ‘Implants are safe but I’m going over the checklist with you just because I have to’?”

Dr. Ashar: “FDA regulates medical device manufacturers. The manufacturers are going to be responsible for ensuring that they are compliant with the restrictions. We are committed to using our full authority to assure the safety of breast implants. It’s hard to contemplate what might occur in those situations but we take these restrictions very seriously and we think that manufacturers should as well.”

[Note: The FDA does not regulate doctors or medical treatments.]

Pickel: “This is going to affect women, not just in the US, but all over the world. There are thousands of reporters. Why did you take the time to talk to me?”

Audra Harrison: “I made that decision Kris. We know and we are aware of your interest in this issue. You cover the FDA fairly. You cover these issues thoroughly and fairly. So I was happy to recommend putting you on our call list today.”