National Center for Health Research
We are urging the FDA to include a black box warning about the risks of cancer and other serious health problems for women considering breast implants. As suggested by thousands of cancer patients and augmentation patients, we are also urging the FDA to require a Checklist to be read and signed by all patients, to make sure they are aware of the many risks of breast implants.
See the checklist here or below:
BLACK BOX WARNING
Breast implants can cause a type of cancer of the immune system called BIA-ALCL (Breast implant associated anaplastic large cell lymphoma). Augmentation patients, reconstruction patients, and women with silicone or saline breast implants have developed this rare disease, which can be fatal if not caught early. Almost all women who developed BIA-ALCL had textured breast implants.
In addition, research suggests that women with breast implants have a small but significant increase in their chances of developing certain autoimmune or connective tissue diseases. Thousands of women with silicone gel or saline breast implants have reported debilitating symptoms that are typical of autoimmune, neurological, rheumatologic, or connective tissue diseases, such as joint or muscle pain, fibromyalgia, mental confusion, and painful skin conditions. Most recover significantly when their implants are removed and not replaced.
BREAST IMPLANT PATIENT/DOCTOR CHECKLIST
There are patients with silicone or saline breast implants that have experienced health problems, including cancer. These are in addition to surgical risks such as infection, necrosis (skin death), or problems with anesthesia. The purpose of this checklist is to provide information for patients considering breast implants, so that they can carefully weigh the risks and benefits of breast implants and make the decision that is right for them.
After reviewing the Patient Information Booklet, please read and discuss the items in this checklist with your surgeon. You should not initial or sign the document, and should not undergo the procedure, if you do not understand each of the issues listed below.
How long do breast implants last?
I understand that breast implants are not expected to last for the rest of my life and are likely to break within 10-15 years. Although less common, some break within just a few months or years. It is likely that I will need other surgeries related to my breast implants over the course of my life and if I am a cosmetic surgery patient these surgeries will probably be at my own expense and not covered by health insurance. These additional surgeries and procedures can include implant removal with or without replacement, muscle and tissue repair, scar revisions, MRI diagnostic exams, or other surgeries. I understand that undergoing multiple surgeries may increase my chances of scarring and permanent breast deformity.
Who shouldn’t get breast implants?
I understand that the safety of breast implants has not been established for people who have autoimmune symptoms or diseases, or a family history of those diseases. Breast implants may be more likely to cause serious health problems for those people. In addition, breast implants are not safe for anyone with a weakened immune system or certain genetic traits, most of which are not yet identified.
Chemicals and Metals in Breast Implants
I understand that all breast implants contain chemicals and small amounts of heavy metals that may cause health problems. I understand that most of these chemicals stay inside the shell of the implant but small quantities have been found to diffuse (bleed) through the implant shell, even if the implant is intact and not ruptured or leaking.
Rupture and Leakage
I understand that most breast implants will eventually rupture, usually within 10-15 years. When a saline implant ruptures, it usually deflates quickly. When a silicone gel implant ruptures, I may not notice any changes and the rupture may not be detected by my doctor or by MRI or sonogram. I understand that an MRI is recommended for silicone gel breast implants 3 years following surgery and every 2 years after that to check for silent rupture, and that these MRIs are not usually covered by health insurance. I understand that silicone can migrate from my implant into nearby tissues such as the chest wall, lymph nodes under the arm, upper abdominal wall, and into organs such as the liver or lungs where it cannot be removed. Since migrated silicone can cause health problems, ruptured silicone gel implants should be removed as soon as possible. I understand that, if needed, treatment of these conditions may be at my own expense and not covered by insurance or a manufacturer warranty.
ALCL (Anaplastic Large Cell Lymphoma)
I understand that there is a risk for me to develop BIA-ALCL, a cancer of the immune system. BIA-ALCL is a type of lymphoma that develops in the tissue and fluid around the breast implant. I understand that the symptoms of BIA-ALCL include breast swelling, lumps, pain, and asymmetry that develop after surgical incisions are completely healed, usually years after implant surgery.
Treatment for BIA-ALCL includes removal of the implant and scar capsule, and may include chemotherapy and radiation. This diagnosis and treatment may be at my own expense and is not always covered by insurance.
Symptoms of “Breast Implant Illness”
I understand that tens of thousands of women have reported that they have experienced debilitating health problems associated with their implants, either immediately after getting implants or years later. These often include many different symptoms, such as: joint and muscle pain or weakness, memory and concentration problems, chronic pain, depression, fatigue, chronic flu-like symptoms, migraines, or rashes and serious skin problems.
Studies of thousands of women with implants have shown that they are significantly more likely to be diagnosed with one or more of the following diseases compared to other women:
- Chronic Fatigue Syndrome – a serious, long-term illness that causes severe, long-term fatigue that makes it difficult to function.
- Multiple Sclerosis (MS) – a nervous system disease affecting the brain and spinal cord.
- Rheumatoid Arthritis (RA) – pain, swelling, stiffness and loss of function in the joints.
- Sjögren’s syndrome – an autoimmune disease that causes dry mouth and dry eyes.
- Systemic Sclerosis/Scleroderma (SSc) – a group of diseases that cause abnormal growth of connective tissue and can result in hard skin and painful joints.
Although women who develop these symptoms or diseases can’t be certain that they were caused by breast implants, research suggests that most symptoms disappeared or improved significantly after having their implants and capsules removed.
I understand that the most common complication of breast implants is when the scar tissue capsule that forms around the implant hardens or squeezes the implant. In some cases, this can be very painful, distort the shape of the breast, and can make mammography painful and very inaccurate. Implant removal is the only recommended way to fix this problem.
I understand that all breast implants can interfere with mammography and breast exams, possibly delaying the diagnosis of breast cancer. I understand that if I get breast implants, I should inform the mammography technologist about the implants and ask for additional views to improve the accuracy. I understand that mammography can also cause the breast implant to rupture or leak.
Interference with Breastfeeding
I understand that breast implants and breast surgery may interfere with my ability to successfully breastfeed.
Loss of Sensation to Breast or Nipple(s):
I understand that breast implants and breast surgery may damage the nerves in the breast, which may cause the nipple and breast to be painful, or have decreased sensation. These changes may be temporary or permanent, and may affect sexual response or the ability to nurse a baby.
Cosmetic Complications: Asymmetry, Implant Displacement, Ptosis
I understand that if my breasts had slightly different shapes before surgery, they may remain slightly different after surgery. I understand that the implants may cause the breasts to look slightly different in size or shape. I understand that the implant may move from the original placement location and that may result in asymmetry or other cosmetic problems. Breast implants can cause the breasts to sag over time due to the weight of the implants. I understand that if I am not happy with the results, I may need future surgeries to improve the appearance of my breasts.
CONFIRMATION OF DISCUSSION OF RISKS
Patient: I acknowledge that I have received and read the Breast Implant Patient Information Booklet and this checklist. I have had time to discuss the information in both with my doctor, and understand the benefits and risks of the implants and surgery.
___________________________________________________Patient Signature & Date
Physician: I acknowledge that I have discussed the benefits and risks of breast implants as described in the Breast Implant Patient Information Booklet and this checklist. I have encouraged the patient to ask questions, and answered all questions accurately.
___________________________________________________Physician Signature & Date