Category Archives: Reconstruction Decision

The Breast Implant Working Group’s Breast Implant Black Box Warning and Patient Checklist

Augmentation Decision, Reconstruction Decision

This black box warning was developed by the Breast Implant Working Group, which consisted of Dr. Diana Zuckerman (National Center for Health Karuna Jaggar (Breast Cancer Action), Judy Norsigian (Our Bodies Ourselves), Maria Gmitro (Breast Implant Safety Alliance), patient advocate Renee Ridgely, and  As individuals, 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.

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).  People with silicone or saline breast implants have developed this rare disease, which can be deadly if not treated early. Almost all women who have developed BIA-ALCL have had textured breast implants or expanders at some point.

Several studies also suggest that women with breast implants have a small but significant increase in their chances of developing certain autoimmune or connective tissue diseases. Women with silicone gel or saline breast implants have reported symptoms that are sometimes serious, such as joint or muscle pain, fibromyalgia, mental confusion, and painful skin conditions.  Many of these symptoms improve partially or completely when their breast implants are removed and not replaced.

THE BREAST IMPLANT WORKING GROUP’S PATIENT INFORMED CONSENT CHECKLIST

This checklist was developed by the Breast Implant Working Group in 2019, which consisted of Dr. Diana Zuckerman (National Center for Health Research), 2 former presidents of the American Society of Plastic Surgeons, Jamee Cook (Breast Implant Victim Advocacy), Raylene Hollrah (Just Call me Ray), and Karuna Jaggar (Breast Cancer Action). The checklist has been endorsed by their organizations, as well as by the Breast Implant Safety Alliance and Our Bodies Ourselves, as a requirement to be read and signed by all potential breast implant patients.

See the checklist here or below:

BREAST IMPLANT PATIENT/DOCTOR CHECKLIST 

The purpose of this checklist is to provide information for patients considering breast implants for augmentation or reconstruction, so that they can carefully weigh the risks and benefits of breast implants and make the decision that is right for them. The risks in this checklist are in addition to common surgical risks such as infection, necrosis (skin death), or problems with anesthesia.

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.  Implants may rupture or leak at any time, and that is more likely the longer you have them.  In addition, it is likely that I will need other surgeries related to my breast implants over the course of my life.  If I am a cosmetic surgery patient, my health insurance policy may refuse to cover these surgeries. These additional surgeries and procedures can include implant removal with or without replacement, muscle and tissue repair, scar revisions, MRI diagnostic exams, or other procedures. I understand that undergoing multiple surgeries may increase my chances of permanent breast deformity.

Patient Initials____________

Who shouldn’t get breast implants?  I understand that the safety of breast implants was never studied 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 and symptoms for these people.  In addition, breast implants may not be safe for anyone with a weakened immune system or certain genetic risk factors that have not yet been identified.

Patient Initials____________

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 are confined to the shell of the implant or stay inside the shell.  However, small quantities have been found to diffuse (bleed) from or through the implant shell, even if the implant is intact and not ruptured.

Patient Initials____________

Rupture and Leakage:  I understand that the longer my breast implants are in place, the more likely they are to rupture, especially after the first few 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 mammogram, 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 often are not covered by health insurance. I understand that silicone may migrate from the implant into nearby tissues such as the chest wall, lymph nodes, upper abdominal wall, and into organs such as the liver or lungs where it cannot be removed. Since migrated silicone can cause health problems, it is currently recommended that any ruptured silicone implant 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.

Patient Initials____________

BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma):  I understand that there is a small risk for me to develop BIA-ALCL, a cancer of the immune system. BIA-ALCL is a type of lymphoma that develops on or around the scar capsule that surrounds 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, if not treated early, may include chemotherapy and radiation. This diagnosis and treatment may be at my own expense and is not always covered by insurance.

Patient Initials________________

Symptoms of “Breast Implant Illness:” I understand that because of the lack of long-term safety data, we are still learning about the health problems that result from breast implants.  To date, thousands of women have reported to the FDA or to researchers that they have experienced serious health problems that several studies have linked to their breast implants. This may occur either immediately after getting implants or years later. These often include 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 skin problems.

Several studies of women with breast 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 • Multiple Sclerosis (MS) • Rheumatoid Arthritis (RA) • Sjögren’s syndrome  • Systemic Sclerosis/Scleroderma

Although women who develop these symptoms or diseases can’t be certain that they were caused by breast implants, several studies indicate that most symptoms improve partially or completely after having their implants and capsules removed.

Patient Initials____________

Capsular Contracture:  I understand that one of the most common complications of breast implants is when the scar tissue capsule that forms around the implant hardens. In some cases, this can be quite painful, distort the shape of the breast, and can make mammography more painful and less accurate. Removing the implant and capsule without replacing the implant is the only recommended way to guarantee that this problem is corrected.

Patient Initials____________

Breast Cancer:  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.

Patient Initials____________

Interference with Breastfeeding:  I understand that breast implants and breast surgery may interfere with my ability to successfully breastfeed.  No long-term research has been conducted to determine the possible transmission of chemicals and heavy metals in the breast milk of women with implants.

Patient Initials____________

Loss of Sensation to Breast or Nipple(s): I understand that breast implants and breast surgery may cause the nipple or breast to be painful, or to have decreased sensation. These changes may be temporary or permanent, and may affect sexual response or the ability to nurse a baby.

Patient Initials____________

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.

Patient Initials____________

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

Breast Implants After Mastectomy: Risks You Need to Know

Reconstruction Decision

The complication rate for getting breast implants after mastectomy has been described by experts as “alarmingly high and arguably unacceptable,”1 even though most of the information about complications is based on studies that were paid for by companies that make breast implants or silicone.

How safe are breast implants and how many women have complications after getting reconstruction with breast implants after a mastectomy? When the Food and Drug Administration (FDA) approved breast implants, they acknowledged that the complication rate is very high for all women, especially those undergoing reconstruction after a mastectomy. What the FDA did not know, however, is that early-stage breast cancer patients that undergo mastectomy and reconstruction with breast implants are 10 times as likely to commit suicide as other early-stage breast cancer mastectomy patients.

Complications from Implants

We do not know why the suicide rate is so high for mastectomy patients with breast implants, but we do know that complications are very common. For example, a study conducted by implant manufacturer Inamed (now called Allergan) found that 46% of reconstruction patients needed additional surgery within the first 2 to 3 years after getting silicone gel breast implants 2. Not surprisingly, the implant maker did not publish an article describing this high complication rate, which was more than twice as high as the 21% reported in a study funded by a company that makes silicone (Dow Corning).1

Why was the complication rate lower in the Dow Corning study? One explanation is that the women in that study had breast implants for an average of only 23 months, compared to 2-3 years in the Inamed study. Even so, the Dow study found that 31% of the women developed at least one serious complication and 16% developed at least 2 serious complications in that short period of time. The Inamed study reported that 25% underwent implant removal, 16% experienced Baker III-IV capsular contracture (which is painful breast hardness), 6% experienced necrosis (death of breast tissue), 6% had other types of breast pain, and 6% had an implant that ruptured, and other women reported infections and other complications.2  This shows that both studies found very high complication rates despite a short follow-up of less than 3 years.

The Dow-funded study concluded that “reconstruction failure (loss of implant) is rare.” Of course, it should be rare after less than 2 years. In contrast, when Inamed used Magnetic Resonance Imaging (MRIs) to detect rupture, they found that 20% of reconstruction patients had ruptured implants by the third year;3 but very few ruptures were detected without MRIs. Since Henriksen did not use MRIs. Since the Dow Corning study did not use MRIs to detect rupture, they couldn’t accurately count the number of failed implants.  Moreover, FDA scientists concluded that the risk of rupture would likely increase exponentially every year.4

Many plastic surgeons claim that the Institute of Medicine concludes that breast implants are safe. However, the Institute of Medicine report was completed in 1999, years before most research was conducted. Most research on breast implant patients was published after 1999, making the report very outdated. Many of the studies reported higher levels of diseases or symptoms among women with breast implants, which would have reached statistical significance if the studies were larger and women were followed for a longer period of time.

Can implants cause cancer or other serious diseases?

Experts around the world now agree that breast implants can cause a type of cancer of the immune system called ALCL (anaplastic large cell lymphoma).  In fact, there is now a specific diagnosis called breast implant associated ALCL (BIA-ALCL).  If caught early, removal of the breast implants can be very effective, but if not treated quickly it can be fatal. 5

The link between breast implants and other cancers remains controversial.  Studies paid for by plastic surgeons or implant companies tend to conclude that breast implants are safe. Since breast implants can cause cancer of the immune system, it seems logical that implants might have an impact on other diseases of the immune system or other cancers.  For example, FDA scientists reported a significant increase in fibromyalgia and several other autoimmune diseases among women whose silicone gel breast implants were leaking, compared to women with silicone implants that were not leaking outside the scar tissue capsule.4 In addition, scientists at the National Cancer Institute (NCI) found a doubling of deaths from brain cancer, lung cancer, and suicides among women with breast implants compared to other plastic surgery patients.6 National Cancer Institute scientists concluded that more research was needed to determine if implants increase the risk of cancer or autoimmune diseases.5,6

The Bottom Line

Many women choose mastectomies to “get rid of the cancer once and for all” hoping that it is the safest strategy for dealing with breast cancer.  However, research shows that women who have lumpectomies live longer than women with the same diagnoses that chose mastectomies instead. Research makes it clear that there are many complications from breast implants that often keep women needing additional surgery and medical help in the years after breast cancer is removed, including the possibility of cancer of the immune system.  Unfortunately, many women tell us that their doctors did not warn them about these risks. [Read a New York Times article about a woman with ALCL here.]

Some of the information from this article was based on Dr. Zuckerman’s article published in Archives of Surgery, Vol 141, pages 714-715. The original article can be found here.

Unnecessary Mastectomies: Are Breast Cancer Patients Given Accurate Information About Their Options?

Reconstruction Decision

It is shocking but true: approximately 70 percent of American women who have a breast removed as treatment for cancer do not need such radical surgery. 7 Whether a woman undergoes a mastectomy or a lumpectomy (which removes the cancer but not the breast) depends less on her specific diagnosis than on other factors, such as where she lives, her income and health insurance, where she receives medical care, her age, and when her doctor was trained.

Experts agree that for most early-stage breast cancer (stage 0, 1, 2, or 3a), lumpectomy is just as safe as mastectomy, if the lumpectomy is followed by radiation treatment. 8 9 10 In fact, a 2013 study indicates lumpectomy patients live longer than mastectomy patients.  11 At a 1990 Conference sponsored by the National Institutes of Health, experts agreed that since survival rates were the same, lumpectomy followed by radiation is the preferable treatment for most women with early-stage breast cancer. But even today, almost 4 decades later, many women eligible for breast-conserving surgery are getting mastectomies. Although it’s been known for years that lumpectomy and other breast-saving surgeries are just as effective as mastectomy for patients in the early stages of breast cancer, in many parts of the country most of the women who receive an early-stage diagnosis will undergo the more radical and disfiguring surgery. Limited information and biased recommendations are undermining breast cancer patients’ choices.

Articles published in some of America’s most prestigious journals show that many of the 268,600 women who are newly diagnosed with invasive breast cancer and more than 60,000 women who are diagnosed with ductal carcinoma in situ (DCIS), or early-stage breast cancer, each year do not have access to all the information they need to make the treatment choices that are best for them.  12 13 This raises questions about what doctors know and what they are telling their patients.

In addition, mastectomy is often followed by “reconstructive” breast surgery that involves the use of synthetic breast implants or tissue transfers from other parts of the body. These reconstructive surgeries have risks, but the lack of published epidemiological studies means that many of the women making these decisions have limited information about their safety.

After all the research that has been done on the safety of lumpectomies, why are so many women undergoing mastectomies they don’t need and then having reconstruction that can cause serious problems? One reason is economic — surprisingly, it is less expensive to perform a mastectomy than a lumpectomy. In addition to a more time-consuming surgery, radiation adds to the cost of lumpectomy but is rarely required for mastectomy. Moreover, some insurance plans do not cover all the expenses of the lumpectomy or the radiation therapy, because they are usually outpatient procedures.

Surgical Treatment Disparities:

  • In some hospitals, all breast cancer patients had mastectomies, regardless of their diagnosis. In one large urban hospital serving mostly poor women in Texas, 84% of the women with early stage breast cancer had mastectomies and only 16% had lumpectomies. 14
  • In a study of 157 hospitals, patients treated by doctors trained before 1981 were less likely to have lumpectomies or other breast-saving surgery than women who had younger doctors. For decades, mastectomy was the standard treatment for breast cancer at any stage. Research showing the safety of lumpectomy dates from the mid 1980’s. 15
  • One study indicated that women getting mastectomies were more likely to have followed their doctors’ recommendations, but women getting lumpectomies were more likely to have obtained a second opinion, and felt more actively involved in making the decision. 16
  • Surgeons have a greater propensity towards performing breast-conserving surgery if they practice in an area with higher Medicare fees for breast-conserving surgery, believe in patient participation in treatment decisions, and are female. 17

Women deserve better. Breast cancer patients should make the choices that are best for them, wherever they live and no matter how affluent they are. We need to do a better job of making sure that all doctors and their patients have accurate, unbiased information so that women can make those choices, no matter who they are, or who provides their medical care.

To learn more about cancer prevention, treatment, and policy visit stopcancerfund.org

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.