New FDA Breast Implant Warning Guidelines

Among growing concern about Breast Implant Illness (BII) and a cancer linked to breast implants, the FDA announced new guidelines for patient education about saline or silicone gel fillers used in breast implants. The guidelines are to ensure that “patients considering breast implants have the information they need for a balanced discussion with their physicians regarding the benefits and risks of breast implants.” (See the story of an FDA Committee member’s experience at the meeting on breast implants, Breast Implants: Should They be Banned?)

About three times as many women have breast augmentation as those who have reconstruction. Regardless of why implants are used, they can have repercussions and adverse events for years. Reading through the warnings that the FDA requires before you commit to breast implants might help you decide. The full eight primary documents that the FDA recommends patients read and sign are available at the bottom of this article. Reading them while you are deciding if you should get implants will prepare you for the sheaf of pre-surgical release papers that you will be presented with, possibly at the last minute.

What the FDA Implant Guidelines State

Before Breast Implant Surgery

In the new guidelines, the FDA recommends a “boxed warning” (the FDA’s most extreme warning of possible serious illness caused by the product) on breast implants and a patient decision checklist to ensure the information of risk is received and understood by the patient. Both the Boxed Warning and a sample of the patient checklist are shown below.

In addition to the Black Box Warning, the FDA wants doctors to give patients warnings about specific risks, side effects and adverse events that implants can cause. The new FDA guidelines have a sample “Patient Decision Checklist Example” with eight sub documents all requiring a signature or initial.

The FDA notes in “Breast Implant Specific Risks” that nearly 60% of patients who have a breast implant have a need for a “reoperation.” More than half of the patients complain of painful or tightening of scar tissue around the implant. One of the patient documents is on “Risk of Cancer – Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)” which is associated with breast implants.

BII is not recognized by medical organizations as a disease or syndrome. It has no diagnostic code, and because of that insurance companies don’t cover BII, but they may cover care for the symptoms.

Women who complain of BII list a spectrum of symptoms. According to the FDA, the most common symptoms include fatigue (49%), brain fog (25%), joint pain (25%), anxiety (24%), hair loss (21%), depression (19%), rash (18%), autoimmune diseases (18%), inflammation (18%) and/or weight problems (18%).

The FDA includes an alert of BII in the Systemic Symptoms form with some symptoms listed and also the information that patients have reported their symptoms cleared up after implant removal.

After Breast Implant Surgery

If you decide to have breast implant(s), a patient device card (explaining what device was inserted into your body) should also be provided to you after surgery. The card should include the implant’s serial or lot number; its style and size; its Unique Device Identifier (UDI); and a web link to access most current patient decision checklist, boxed warning, and labeling. It is crucial to keep this card so that you have full information on your implant in the case that you have a problem or if implants are recalled for defects.

These measures are in addition to discussion with your doctors and the information already required to be given to patients.

Long-term Follow Up

Many leaks and ruptures don’t cause immediate symptoms, but need to be fixed because of leakage of toxic silicone or gel into your body. New screening guidelines are included to find ruptures in silicone gel-filled breast implants. Assuming you have no symptoms of a rupture, you should have an ultrasound or an MRI five to six years after the operation and every two to three years thereafter–separately but in addition to regular mammograms or other breast cancer screening.

To report any problems with breast implants to the FDA, go to MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Boxed Warning

The boxed warning will tell patients that:

• Breast implants are not considered lifetime devices;
• The chance of developing complications increases over time;
• Some complications will require more surgery;
• Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL);
• BIA-ALCL occurs more commonly in patients with textured rather than smooth implants;
• Deaths have occurred from BIA-ALCL;
• Breast implants have been associated with systemic symptoms.

The Patient Decision Checklist

Below is a sample checklist composed by the FDA. You should be asked to read the list; be able to ask questions; be asked to sign the list; and be able to keep a copy. This is in addition to a patient information booklet/brochure for the specific implant to be used in your surgery.

Here are the informative forms that the FDA recommends you be presented with and asked to sign. Reading it now, rather than just before surgery, will help you determine if implants are right for you.

• 1. Considerations for a Candidate for Successful Breast Implantation
  2. Risks of Breast Implant Surgery
  3. Risk of Cancer – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
  4. Systemic Symptoms
  5. Breast-Implant Specific Risks
  6. Recommended Follow-up
  7. Questions for my Physician
  8. Options Following Mastectomy
  9. Breast Augmentation Options

All eight forms are from “Breast Implants -Certain Labeling Recommendations to Improve Patient Communication Guidance for Industry and Food and Drug Administration Staff“

1. Considerations for a Candidate for Successful Breast Implantation

I understand that I am not a candidate for breast implants if any of the following situations applies to me:

• I have an active infection anywhere in my body;
• I have an existing cancer or pre-cancer of my breast tissue that has not been adequately treated; or
• I am pregnant or nursing.

I understand that if I have any of the following conditions, I may be at a higher risk for a poor surgical outcome:

• Medical condition that affects my body’s ability to heal (e.g., diabetes, connective tissue disorder);
• Active smoker or a former smoker;
• Currently taking drugs that weaken the body’s natural resistance to disease, such as steroids and chemotherapy drugs (e.g., prednisone, tacrolimus, sirolimus, mycophenolate, azathioprine, cyclosporine, methotrexate, chlorambucil, leflunomide, or cyclophosphamide);
• History of chemotherapy or planned chemotherapy following breast implant placement;
• History of radiation therapy or planned radiation following breast implant placement;
• Conditions that interfere with wound healing or blood clotting (e.g., hemophilia, von Willebrand disease, factor V Leiden, hyperhomocysteinemia, protein C deficiency, antithrombin III deficiency, or systemic lupus erythematosus); or
• Reduced blood supply to the breast tissue.
• I understand the following conditions have not been adequately studied to determine whether the conditions put me at higher risk:
• Autoimmune disease (e.g., Hashimoto’s, Lupus, Rheumatoid Arthritis) or family history of autoimmune disease (breast implant premarket clinical studies have not evaluated the safety of breast implants in patients with autoimmune disease);
• Clinical diagnosis of depression or other mental health disorder(including body dysmorphic disorder or eating disorder); or
• Have other products permanently implanted in the breast.

Patient Initials: ___________________

2. Risks of Breast Implant Surgery

I understand that there are risks of undergoing breast implant surgery. I understand that risks of undergoing breast implant surgery may include:

• breast pain (reported in up to 36.5% of procedures),
• skin or nipple areola sensitivity changes or loss (reported in up to 35% of procedures),
• asymmetry (reported in up to 28% of procedures),
• impact of aging or weight change on size and shape of breast (reported in up to 10% of procedures),
• infection requiring possible removal of implant (reported in up to 9% of procedures),
• swelling (reported in up to 9% of procedures),
• scarring (reported in up to 7% of procedures),
• fluid collections (seroma) (reported in up to 6.5% of procedures),
• hematoma (reported in up to 2.8% of procedures),
• tissue death of breast skin or nipple (reported in up to 2% of procedures),
• inability to breast feed (reported in up to 1.6% of procedures),
• complications of anesthesia (reported in up to 1% of procedures),
• bleeding (may occur but specific rates are not publicly available in Summaries of Safety and Effectiveness Data (SSEDs)16),
• chronic pain (may occur but specific rates are not publicly available in SSEDs),
• damage to surrounding tissue, such as muscle, nerves, and blood vessels (may occur but specific rates are not publicly available in SSEDs), and
• Impact on imaging of breast tissue (may occur but specific rates are not publicly available in SSEDs).

My physician has discussed these risks and has provided me with the patient information booklet/brochure (including the boxed warning) with information on the types of risks that are possible and expected rates of occurrence.

My physician has discussed the potential use of other implanted products during my breast implant surgery. My physician has also discussed the risks and benefits of using these implanted products and their planned surgical approach.

Patient Initials: ___________________

3. Risk of Cancer – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

I understand that breast implants are associated with the development of a type of cancer of the immune system called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIAALCL). Information regarding the number of medical device reports of BIA-ALCL can be found on FDA’s website.17 I have received information regarding the overall incidence rates of BIAALCL and the rates as they pertain to my specific breast implant.

I understand that this cancer has been reported more frequently for textured breast implants, but that patients with smooth surfaced implants have also been diagnosed

I understand that patients with breast implants have a risk of developing BIA-ALCL within the scar tissue and fluid surrounding the breast implant.

I understand that BIA-ALCL typically takes several years to develop after implantation, but cases have been reported as early as within one year. Typical symptoms to be aware of include: swelling, breast tightness, pain, lumps, or swelling of the breast months or years after I receive my implants.

I understand that treatment for BIA-ALCL involves an operation to remove the implants and the surrounding scar tissue capsule. Based on the stage of the cancer at diagnosis, some patients have required chemotherapy or radiation. While BIA-ALCL typically responds well to therapy, some patients have died from BIA-ALCL. Diagnosis and treatment may be at my own expense and is not always covered by insurance.

Patient Initials: ___________________

4. Systemic Symptoms

I understand that some patients who have received breast implants have reported a variety of systemic symptoms including joint pain, fatigue, rash, memory loss, and “brain fog” that some patients have called breast implant illness. While the causes of these symptoms are unclear, some patients have reported relief of these symptoms with removal of their implants and surrounding scar tissue capsule, however not all patients may experience improvement in their symptoms. Researchers are working to better understand the possible link between breast implants and these symptoms.

I also understand that some patients with breast implants have reported health problems in their children after birth or breastfeeding. While a causal link between breast implants and these reported health problems in children has not been demonstrated, more research is needed. I understand that breast implants and breast surgery may interfere with my ability to successfully breastfeed.

Patient Initials: ___________________

5. Breast-Implant Specific Risks

I understand that a breast implant is NOT a lifetime device and the longer I have my implants, the more likely I am to experience a complication and the more likely I am to require a reoperation requiring the replacement or removal of my breast implant. As many as 20 percent of women who receive breast implants for augmentation have to have their implants removed within 8 to 10 years, but my implants may last for a shorter or longer time.

I understand that my breast implant may rupture or leak at any time, and that the longer I have my implants, the more likely I am to experience a complication such as rupture. I understand that gel bleed (small quantities of chemicals diffusing from the implant shell) of silicone gel-filled implants may occur. I understand that if I have a saline-filled implant, my breast may deflate in appearance if there is a rupture or leakage of the saline.

I understand that if I have a silicone gel-filled breast implant, I or the physician may not be able to tell on physical exam whether my implant has ruptured or is leaking silicone gel. Because rupture or leakage of silicone gel-filled breast implants is difficult to detect, I understand that periodic imaging evaluation is recommended for screening of silicone gel-filled breast implant rupture. It is recommended that I have periodic imaging of my silicone gel-filled breast implants to screen for implant rupture regardless of whether my implants are for cosmetic augmentation or reconstruction. These recommendations do not replace other additional imaging that may be required depending on my medical history or circumstances (i.e., screening mammography for breast cancer).

Even if I have no symptoms, I should have regular imaging evaluations as described in the “Recommended Follow-Up” section below. These imaging evaluations may not detect all ruptures or leaks, be costly, and the expense may not be covered by my medical insurance.
I understand that silicone can migrate from my implant into nearby tissues (e.g., chest wall, lymph nodes under the arm) and organs (e.g., liver, lungs) where it may not be possible to remove.

I understand that all breast implants can interfere with mammography and breast exams, which could delay the diagnosis of breast cancer. Mammography can also cause the breast implant to rupture or leak. I should tell the mammography technician if I have breast implants.

I understand that the long-term risks of breast implants may include:

• painful or tightening of scar tissue (capsule) around my implant (capsular contracture) (reported in up to 51.7% of patients),
• rupture or leaking of the implant (reported in up to 31.2% of patients),
• wrinkling of the implant (reported in up to 20% of patients),
• visibility of the implant edges (reported in up to 6% of patients),
• shifting of the implant (reported in up to 11.5% of patients), or
• need for reoperation (reported in up to 59.7% of patients).

I understand that I will receive a patient device card after my surgery that has information on each of my specific implants. I understand that it is important for me to keep each card in case I or my physician need to know what kind of implant I have many years later.

I understand that all breast implants contain chemicals and heavy metals. I understand that most of these chemicals stay inside the shell of the implant, but small quantities have been found to diffuse (gel bleed) through the implant shell of silicone gel-filled implants, even if the implant is intact and not ruptured or leaking. A list of the components, chemicals, and heavy metals is available in the patient information booklet/brochure.

Patient Initials: _________

6. Recommended Follow-up

Even if I have no symptoms, I should have my first ultrasound or MRI at 5-6 years after my initial implant surgery and then every 2-3 years thereafter.  If I have symptoms or uncertain ultrasound results for breast implant rupture at any time, an MRI is recommended.

I understand that I will need routine and regular follow-up with my physician as long as I have a breast implant for examination of my breast implant as well as to discuss any updates regarding breast implant issues.

National Breast Implant Registry (NBIR): I understand and have discussed with my physician that there is a National Breast Implant Registry where information regarding my health and breast implant information can be entered. The NBIR may help understand the long-term safety and performance of breast implants.

Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma (ALCL) etiology and Epidemiology (PROFILE): I understand and have discussed with my physician that there is a registry (PROFILE) where information is collected to better understand BIA_ALCL in patients with breast implants.
Patient Initials: _________

7. Questions for my Physician

I have had the opportunity to ask my physician questions about his or her experience, medical degree, specialty of training, and credentials. I understand that breast implants have associated procedural risks and should only be used by physicians who are appropriately trained.
Patient Initials: __________

8. Options Following Mastectomy

I understand that breast reconstruction is an elective procedure which I can choose to do or not.

I understand that I may choose not to have breast reconstruction (“going flat”) and may choose to use an external prosthesis in my bra to look like I have a breast when wearing clothes.

I understand the surgical options for breast reconstruction, including the use of a breast implant and the use of my own tissue (“autologous reconstruction”).

I understand that if my breast implants are ever removed, I may be left with dimpling, chest wall concavity, puckering, or sagging of my breasts or skin.

I understand that more surgeries may be necessary in the future due to complications or to remove or replace the breast implants.

I have discussed all of the options for breast reconstruction with my provider, including whether I am a candidate and the benefits and risks of each, and I believe that breast reconstruction with a breast implant is the best option for me.

Patient Initials: __________

9. Breast Augmentation Options

I understand that breast augmentation is an elective procedure to increase the size of my breasts.

I understand that breast augmentation may result in permanent changes to my breast tissue and if my implants are ever removed, I may be left with unsatisfactory appearance, changes to the size and shape of my breasts, including but not limited to dimpling, chest-wall concavity, puckering, sagging, or different incision size or location.

If I am an augmentation patient, any additional surgeries or medical procedures will likely be at my own expense.

Patient Initials: __________

And two final documents one for you and one for your doctor signing off on the entire packet.