Category Archives: Reconstruction Risks

Capsular Contracture


After getting breast implants, breast pain, hardness, and numbness can develop and last for years. These common complications may never go away. The most common complication of breast implants is capsular contracture. When you get breast implants, your body naturally responds to the foreign object by forming scar tissue around the implants. Capsular contracture occurs when the scar tissue tightens around the breast implant. This can cause the breast to harden and become very painful. It can also change the shape of the implant, making it look abnormal, as shown in the photo below.

A 29-year-old woman with Baker Grade IV capsular contracture. Photo courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

To fix capsular contracture, doctors used to perform a “closed capsulotomy.” This painful procedure involves squeezing the breast very hard to break the scar tissue capsule. This procedure should never be done. Most plastic surgeons do not perform this procedure anymore, but some do. The squeezing can break the implant and the capsule. Closed capsulotomies are not effective, and capsular contracture often comes back.

A plastic surgeon will be able to diagnose capsular contracture through a physical and visual exam. There are different grades of capsular contracture (Baker I, Baker II, Baker III, and Baker IV). They are graded based on the severity of symptoms:

Baker Grading System for Capsular Contracture

Baker I Breast is soft
Baker II Breast is slightly firm
Baker III Breast is firm and possibly misshapen and uncomfortable
Baker IV Breast is hard, painful, and misshapen

Health insurance companies that will pay for breast implant removal usually cover removal when there is severe capsular contracture (Baker III and Baker IV). This is because severe, painful capsular contracture interferes with mammography (breast cancer screening). The pain from severe capsular contracture can also interfere with daily activities, such as reaching above your head.

Capsular contracture does not usually get better by itself. If your breasts become very painful or hard, you will need surgery. Your surgeon would need to remove the scar tissue capsule and the implant. It is possible that some of your own breast tissue will be removed during the surgery because it is attached to the scar tissue. This can reduce the size of your natural breast and/or change their appearance.

If you decide to have your breast implants removed and replaced, it is important to know that capsular contracture is likely to reoccur. Women who have already had capsular contracture are at an increased risk of developing capsular contracture again with their replacement implants. This could lead to an endless cycle of surgeries, so the best treatment option for capsular contracture is permanent removal of the breast implants.

 

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

 

Rupture


If an implant tears or develops a hole, it is called a rupture. Some implant ruptures happen during the first few months, but the older an implant is, the more likely it is to rupture. It’s not always obvious when an implant has ruptured. Here’s what you need to know.

Saline Implant Ruptures

When a saline (salt water) breast implant ruptures, it will probably leak very quickly. The implant deflates much like a balloon that has lost the air inside. As this happens, your breast will change in size and/or shape. If a saline implant leaks slowly, it might not be immediately noticeable. When the saline leaks, the body absorbs it. It is usually harmless unless bacteria, yeast, or mold are inside the implant. They can cause a serious infection. If you notice a change in the size or shape of your saline implant along with symptoms like swelling, redness, or fever you should see a doctor immediately.

Silicone Implant Ruptures

When a silicone gel breast implant ruptures, it usually leaks very slowly. A ruptured silicone gel implant may not be obvious for many years. This is why silicone gel implant ruptures are sometimes called “silent” ruptures. Sometimes, the rupture is discovered only when the implant is removed.

When a silicone implant ruptures, the silicone can either stay inside the capsule (the thick layer of scar tissue that naturally grows around the implant) or it can leak outside the capsule. It is more serious when the silicone leaks outside of the capsule. When this happens, silicone can migrate to the lymph nodes, and from there can go to the lungs, liver, or other organs where it’s impossible to remove. The longer a woman waits to have a ruptured silicone gel implant removed, the more silicone is likely to leak inside her body and cause health problems.

How Do I Find Out If My Silicone Implant Has Ruptured?

If your silicone gel implant ruptures, you might notice a change in the size or shape of your breast. You might feel pain or tenderness, swelling, numbness, burning, or tingling. Or, you might not have any symptoms, making it impossible to know you have a rupture.

Because most women don’t notice when a silicone gel implant ruptures, the FDA recommends having a breast MRI 3 years after getting breast implants. After that, a breast MRI should be done every other year to check for a rupture.

A mammogram is the least accurate way to diagnose a ruptured silicone-gel breast implant. In addition, the pressure could cause the silicone to leak outside the capsule.

What Should I Do If My Implant Ruptures?

If your saline implant has ruptured, you should see a doctor. This is especially important if you feel sick, have a temperature, a rash, or other unexplained symptoms. You could have an infection and require treatment.

If you have ruptured silicone gel implants, they should be removed as soon as possible. The longer the silicone is allowed to remain in the body, the more time it has to migrate to other parts of your body. Once the silicone has moved to other parts of your body, it can’t be removed and may cause other health problems. Just as important as having leaking silicone gel implants removed, is having them removed en bloc. En bloc removal is when the scar tissue (or capsule) and implant are removed at the same time, with the implant still inside the intact scar tissue capsule.  En bloc removal allows the silicone and other chemicals to stay inside the intact scar tissue capsule as it is removed. En bloc removal prevents silicone and other chemicals from leaking into the woman’s body during surgery. It requires a larger incision but it is worth it because it prevents leakage.

Since breast implant removal includes costs (such as anesthesia) that are similar whether you have one implant removed or two, it is usually best to remove them both at the same time, whether or not you want them to be replaced. For example, if your implants were put in at the same time, and one is ruptured, it is likely that the other will rupture soon. One surgery is much less expensive than two.

Can Broken Implants Make Me Sick?

According to research by FDA scientists, women with leaking silicone implants are more likely to report fibromyalgia (widespread body pain and fatigue) or several other diseases, compared to women whose implants are not leaking.1 One study found that 3 out of every 4 women who removed their silicone breast implants saw improvement in their symptoms.2

No research has been published on the health risks of broken saline implants but bacteria from ruptured saline implants have caused women to become ill.

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

Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)


What is BIA-ALCL?

Anaplastic Large Cell Lymphoma (ALCL) is a rare form of cancer of the immune system. Experts now agree that women with breast implants are more likely to develop ALCL.3 Since it will develop in the breast area, it is called Breast Implant Associated-ALCL (BIA-ALCL). Usually, this cancer develops in the scar tissue (capsule) that forms around a breast implant.4 Sometimes this cancer can be found in the lymph nodes. If it’s not treated quickly, it can be fatal.

How can breast implants cause cancer? Why didn’t my doctor mention it?

Scientists are trying to figure out why ALCL forms near breast implants. Many experts believe that cancer may develop in response to chronic inflammation caused by bacteria.5 Most cases of BIA-ALCL have been reported in women with textured implants, which provide a better surface for bacteria to grow.

In December 2018, Allergan’s textured breast implants were taken off the European market. In Europe, breast implants are allowed to be sold if one country provides what is called a CE mark. The CE mark does not require clinical trials and is based on a private company’s review of the product to ensure health, safety, and environmental protection standards are met. The CE mark for Allergan’s textured breast implants was suspended after the company failed to provide French health officials with requested data regarding the textured implants and their link to lymphoma.6 This means that, for now, Allergan textured implants cannot be manufactured or sold in Europe and that the textured implants at clinics are being recalled. Textured breast implants are known to increase the chances of developing a rare form of cancer of the immune system known as Breast Implant Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL. The controversy about whether textured breast implants should remain on the market has focused on what percentage of women with these implants will develop ALCL. Despite the well-established increased risk of lymphoma, textured implants are still being sold in the United States, although the FDA recommends women with textured implants have routine check-ups with their doctors.

The apparent link between ALCL and breast implants was published by cancer experts in 2009.  It wasn’t until 2011 that the Food and Drug Administration (FDA) warned the public, and it wasn’t until 2013 that cancer researchers published an article in a medical journal stating that breast implants could cause ALCL.  As of 2018, BIA-ALCL is widely recognized by cancer experts, but still not all oncologists or plastic surgeons are aware of it.  Many breast cancer survivors are upset to realize that their “cautious” choice to have a mastectomy with implants rather than a lumpectomy puts them at risk of developing another type of cancer, ALCL.

Is BIA-ALCL really rare?

As of September 2017, the U.S. Food and Drug Administration (FDA) reports that it has received 414 reports of ALCL, including 9 deaths, in women with breast implants. They say that since millions of women have breast implants, BIA-ALCL must be very rare. However, the Australian version of the FDA (called the Therapeutic Goods Administration) estimates that between 1 in 1,000 and 1 in 10,000 women with breast implants will develop ALCL.7 More than 300,000 women get breast implant surgery every year. If the Australian estimates are correct, about 30-300 of those women will develop ALCL every year.

Many experts believe that ALCL is underreported and therefore the chance of developing ALCL from breast implants is likely higher than the current estimates. Although awareness of BIA-ALCL is increasing, many doctors are still unaware of the risks and symptoms.

How will I know if I have BIA-ALCL?

All women with breast implants should be seeing a doctor regularly to check for any problems. If you experience redness or swelling near your implants you should see a doctor immediately. A swollen breast is usually an infection, but the fluid around your implants should be tested for ALCL as well.

Although a swollen breast is the most common symptom of BIA-ALCL, not all women with BIA-ALCL have noticeable swelling. Some women with BIA-ALCL reported feeling a lump near their implant or capsular contracture. If you find a lump, see your doctor immediately to check for breast cancer or ALCL. If you have capsular contracture, keep in mind that it could be a sign of BIA-ALCL, even though it probably isn’t.

How can I prevent BIA-ALCL?

You can’t prevent ALCL if you have breast implants. However, you can watch out for warning signs mentioned and have regular checkups with a doctor who knows about BIA-ALCL and other risks associated with breast implants.

What is the treatment for BIA-ALCL?

ALCL is treated by removing the implant and all of the surrounding scar tissue. This procedure is called a total capsulectomy. This is done to make sure any cancer cells in the tissue are removed.

If any of your lymph nodes are found to have ALCL, they will also be removed.

If the cancer is found later and has spread, you may need to be treated with chemotherapy or radiation therapy.

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

Autoimmune Symptoms and “Breast Implant Illness”


Thousands of women have reported health problems after getting breast implants, including muscle and joint pain, chronic fatigue, mental confusion, rashes, dry eyes, and hair loss. These symptoms can suddenly develop right after getting breast implants, or they can develop gradually years later.

The Food and Drug Administration (FDA) approved breast implants more than a decade ago, but acknowledged that “studies would need to be larger and longer” to determine if implants could cause the symptoms and diseases many women are reporting.8 Many of the women refer to these symptoms and diseases as “breast implant illness,” although most physicians do not consider this term to be a medical diagnosis.

In their safety studies that were used for FDA approval, breast implant companies intentionally excluded women who had a family or personal history of autoimmune disease before getting implants. This is because those women might be more likely to have health problems from the implants. Breast implant companies recognize this as a shortcoming of their studies. For example, this is what Mentor says in their label for MemoryGel® implants:9

Safety and effectiveness have not been established in patients with the following:

Autoimmune diseases (for example, lupus and scleroderma)…”

Unfortunately, most physicians and most women considering implants are unaware of that warning.

What Is Autoimmune Disease?

Autoimmune diseases are conditions where immune cells attack your body. Immune cells usually help our bodies fight off infections and foreign substances. However, when immune cells react to silicone as a foreign substance, that can sometimes cause the body to start an immune response. In some cases, the immune system starts attacking the body. This can result in many different symptoms like joint pain, fatigue, mental confusion, dizziness, fever, and hair loss. Some women with breast implants report many different symptoms that do not fit with the diagnosis of one specific disease. Over time, some women develop a pattern of symptoms that are diagnosed as lupus, scleroderma, fibromyalgia, Sjogren’s Syndrome, Hashimoto’s, or other diseases.

Autoimmune diseases can target organs, such as the brain or liver. They can also involve many tissues, such as muscles or blood.10 In addition to autoimmune diseases, silicone-related diagnoses include raynaud’s disease, irritable bowel syndrome, and allergies.

Many autoimmune symptoms are also connective tissue symptoms, so the terms overlap.

Not all women with breast implants develop these health problems. It is possible that some women are more likely to develop autoimmune symptoms, such as those with a personal or family history of autoimmune disease, allergies, or a compromised immune system.11 Women who already had an autoimmune disease before getting breast implants may find that their symptoms got worse after getting breast implants. Certain genes may also increase the chances of developing autoimmune diseases or symptoms, sometimes as a reaction to silicone or other exposures.

How “Good” Is the Evidence?

There is conflicting evidence from studies that examined whether breast implants cause autoimmune disease or symptoms. Most of the existing studies were funded by implant companies or plastic surgery associations, and they tended to focus on narrowly defined disease diagnoses, rather than the symptoms that many women report. Some studies even relied on hospital or medical records. These types of studies do not accurately capture the magnitude of the issue because most women who experience symptoms are not hospitalized and do not receive specific diagnoses. Despite those challenges, there is a growing body of evidence that breast implants can cause autoimmune symptoms and connective tissue symptoms in some women.

In 2001, FDA scientists reported that women whose ruptured breast implants leaked silicone outside the scar tissue surrounding the implant were significantly more likely to have been diagnosed with fibromyalgia (a painful soft-tissue disease), pulmonary fibrosis, and connective-tissue diseases such as dermatomyositis.12 Fibromyalgia is a disorder that causes widespread pain in the body as well as fatigue. Little is known about how fibromyalgia develops, but researchers think it is an immune system problem.

In 2004, scientists from the National Cancer Institute reported that women with breast implants were more likely to have autoimmune symptoms. However, because symptoms were self-reported, the scientists concluded that more reliable research was needed to determine if breast implants caused specific symptoms or diseases.13

The National Center for Health Research reviewed dozens of research studies of the health problems of women with breast implants. This report points out the weaknesses in each study and highlights what we do and do not know about breast implant illness.

In 2018, researchers at the MD Anderson Cancer Center analyzed data that implant companies submitted to the FDA and published in a medical journal. The researchers found that “silicone implants are associated with an increased risk of certain rare harms.” For example, certain autoimmune diseases (such as Sjögren syndrome) increased by as much as 800%, among women with breast implants. However, the study had limitations because most of the women in the studies dropped out after just a few years.14

A study of more than 56,000 Israeli women, including more than 11,000 with breast implants, was published in 2018 in the International Journal of Epidemiology. They found that women with breast implants were significantly more likely to develop several autoimmune and rheumatic disorders, in particular sarcoidosis, systemic sclerosis, and Sjögren’s syndrome. 15

In recent years, the discovery that breast implants could cause cancer of the immune system (ALCL) supports the claim that breast implants can have a harmful impact on the immune system.

Treatment

If you already have breast implants and have any of the above symptoms that are not responding to other treatment options, research suggests that you may want to consider permanently removing your breast implants. Although there is no guarantee that removing your breast implants will improve your autoimmune symptoms, studies show that it is a very reasonable strategy. 

Many women with breast implants report that these symptoms greatly improved or completely disappeared after their breast implants were removed and not replaced. A study published in 2013, by researchers in the Netherlands, found that 69% of women with autoimmune symptoms who had their implants removed experienced reduction in symptoms and almost 20% experienced full recoveries after explantation.16 A meta-analysis, which is a type of study that combines the results from several studies, found that on average, 3 out of 4 women who removed their silicone breast implants saw improvement in their symptoms.17 The National Center for Health Research surveyed 449 women who had their breast implants removed, and more than 85% said their symptoms improved after explant.

For more information on removing your implants and finding a qualified surgeon, read our article here on explant.

The Bottom Line

Although well-designed large and long-term studies are lacking, for decades women with implants have reported developing autoimmune symptoms that later improved when their implants were removed.

If you already have an autoimmune disease, breast implants could make your symptoms worse. If autoimmune disease runs in your family, you may be at increased risk of developing an autoimmune reaction to breast implants.

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

Breast Pain, Redness, or Swelling


You may experience breast pain immediately after your surgery or years after your surgery. It’s important to find out what is causing your breast pain so that you can try to reduce it.

As with any surgery, augmentation patients should expect to feel pain immediately after surgery. However, pain that lasts for months or longer can have many different causes and requires treatment. It can be a sign of an infection, especially if the pain is accompanied by redness, swelling, and tenderness.

Pain can also be caused by capsular contracture, which is when scar tissue that has developed around the implant tightens or hardens. The breast will feel hard and may change shape. The more severe the capsular contracture becomes, the more pain you will experience.

Nerve injury can also cause chronic breast pain or loss of sensation (numbness) of the breast and nipples. Studies have found that between about 13 and 15% of augmentation patients experienced nerve injury or changes in sensation after surgery. Damaged nerves heal slowly and may not ever heal. If the nerve injury is severe enough, additional surgery may be recommended.

Swelling in the breast can be caused by infection, rupture, or Anaplastic Large Cell Lymphoma (ALCL), a cancer of the immune system. If you notice swelling in your breasts, your doctor should test the fluid around your implant for signs of bacteria or signs of cancer.

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

Extrusion, Pain, and Cosmetic Complications


Extrusion

Extrusion is when a breast implant comes through the skin and becomes exposed. It is an uncommon, but dangerous, complication of breast implant surgery. It typically occurs if the incision wound does not heal properly, the tissue dies (necrosis), or there is not enough breast tissue and skin to support the implant.  

Certain factors can increase the risk of extrusion due to improper wound healing. They include:

  •        Breast implants that are too big
  •        Underlying health issues, such as diabetes
  •        Women who smoke
  •        Overexertion, especially right after surgery
  •        Radiation therapy for breast cancer

Extrusion requires additional surgery, which may cause scarring or loss of breast tissue.

Neck, back, and chest pain

The added weight of breast implants can strain the muscles in your neck, back and chest, resulting in pain and poor posture. Muscle strengthening exercises can offer pain relief, but implant removal is needed if the pain doesn’t go away.    

Appearance

Sometimes breast implant surgery can have disappointing cosmetic results. If you are unhappy with how you look, another surgery might be required, which can be emotionally, financially, and physically stressful. The risk of an undesirable outcome can be reduced (but not eliminated) by choosing an experienced, board-certified surgeon. The following are few examples of complications that can give you a less than desirable outcome:

  •        Asymmetry — uneven size, shape and/or level of breasts
  •        Implant displacement or malposition — when the implant moves from the correct position
  •        Implant wrinkling or rippling
  •        Ptosis — breast sagging, which will happen over time due to the weight of the implant, breastfeeding, or the natural result of aging

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

Infection


All surgical procedures come with immediate risks, like reactions to anesthesia, bleeding, and infections. Infections can happen after breast augmentation surgery if bacteria gets into the incision site. These infections can be serious. The Food and Drug Administration (FDA) warns that toxic shock syndrome, a life-threatening complication from bacterial infections, has been reported following breast augmentation surgery.

Plastic surgeons try to minimize the risk of infection during surgery by keeping the incision site and the implant sterile. There are different ways that surgeons put the implant into the breast to reduce the chances of infection.

Symptoms of infection include redness, heat, drainage, or swelling around the area of the stitches or scar. Other symptoms include a fever, rash, nausea, fatigue, nipple discharge, and vomiting. After augmentation surgery, you should monitor your breast(s) for signs of an infection. If you develop symptoms, you should see a doctor immediately.

Some women develop infections near or related to their breast implants months or years after surgery. Some studies have shown that textured implants, which have a bumpy surface, provide an ideal surface for bacteria to live and grow. If you have textured breast implants, you may be at a greater risk for an infection. Some women have also reported infections caused by saline filled implants that were contaminated with bacteria. If a contaminated saline filled implant ruptures,  the bacteria or fungus can get out into the surrounding area or travel throughout your body. This can be very dangerous. If you notice a change in the size or shape of your implant around the same time as symptoms like swelling, redness, or fever, you should see a doctor immediately.

If you develop an infection related to your breast implants, you will need antibiotics. Some women will require hospitalization and intravenous antibiotics (medications that go directly into your bloodstream to fight off the infection). If your infection doesn’t respond to antibiotics, your implants will need to be removed.

It is important for you to know that swelling can be a symptom of an even more serious medical issue called Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system caused by breast implants. ALCL is also more likely to develop around textured breast implants. If the swelling is not eliminated by the antibiotic, immediately ask your doctor to get the fluid tested for ALCL.

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

Interference with Breast Cancer Detection


Breast implants make it more difficult to detect breast cancer. If you are considering getting breast implants or already have breast implants, it is important to know how they can make mammography and breast exams less accurate.

Mammography is used to screen for and detect breast cancer. Breast implants make mammography less accurate because they can hide cancer that is growing behind or around the implant. 18 According to a research study published in the British Medical Journal, women with cosmetic breast implants who are diagnosed with breast cancer, are more likely to die from the disease compared to women without breast implants who are diagnosed with breast cancer.19 The study found that women with breast implants were more likely to be diagnosed with a later stage breast cancer, compared to women diagnosed with breast cancer without breast implants. This likely occurred because implants interfere with mammography, making it difficult to diagnose breast cancer early.

A mammogram is a type of x-ray. Breast tissue will look grey on the mammogram, and cancer will look white. In a mammogram, implants are also white and will look like a bright white orb. If there is cancer in breast tissue that is below or very near the implant on the mammogram, it probably will not be visible, and therefore won’t be detected.

Here is an example of what implants look like on a mammogram:20

Severe capsular contracture can interfere even more with the accuracy of mammography. It can also cause mammography to be unbearably painful. Capsular contracture is when the scar tissue capsule around the implant tightens and hardens. If you have severe capsular contracture, it may not be possible for you to have a mammogram.

If you have breast implants and need to have a mammogram, you should tell the technician that you have breast implants. You can go to a mammography center that has experience doing mammograms on women with breast implants. The technician will need to take extra x-ray pictures and will have to push your implants to the side, which can be painful.

Mammography also can cause breast implants to break (rupture) or leak. If you have silicone gel-filled implants, this rupture may not be noticeable, but it can cause pain or health problems. To prevent extensive leakage, it is important to have regular breast MRIs to check for silicone gel leakage. If the rupture is not detected, silicone gel can leak through the body and cause serious medical problems.

If you have silicone gel breast implants that are leaking, they can cause lumps (silicone granulomas) that can be mistaken for breast cancer. It can also be difficult to know when a lump really is breast cancer. If you have any lumps, be sure to have them checked for cancer right away. If they are from leaking silicone, it is important to have your implants removed.

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

Pregnancy and Breastfeeding Concerns


When considering whether to have breast implant surgery, you should take your future plans for childbearing and breastfeeding into consideration.

Pregnancy

Although some researchers believe that having breast implants may harm a growing fetus, there is a lack of research to determine if this is true. Researchers who believe that implants can result in autoimmune issues or birth defects in children have several theories: 1) silicone molecules travel through the placenta from mother to baby, 2) mothers form antibodies from silicone exposure that transfer to their fetuses, and 3) autoimmune issues experienced by the mother are inherited by the baby.21

 However, there are not enough well-done studies to prove that any of these theories are true.

There are other reasons why women who are planning to get pregnant may want to avoid breast implants. Pregnancy can cause drastic changes in breast size and shape, so having implants may affect the shape of breasts after the baby is born. When breast implants are initially placed, the surgeon normally uses the natural shape of the breast as a guide. After pregnancy and breastfeeding, implants may no longer enhance the look of the breast in the way that they did before.

Breastfeeding

Breastfeeding has many health benefits for an infant, including immune strengthening, neurological development, and nutritional intake. Additionally, the skin-to-skin contact during feeding promotes bonding between a mother and child. Studies indicate that women with breast implants may find it difficult to produce enough milk due to pressure on the milk ducts from implants or damage to mammary glands or ducts during the implant surgery. For example, several studies show that women with implants were more likely to need to supplement their baby’s diet with formula, because they were unable to produce enough breast milk to feed their baby.22

 This information is important for any woman who plans to become pregnant in the future, and especially for women who previously had difficulty with breastfeeding.

Mothers with silicone implants have expressed concern that silicone could get into their breast milk. However, researchers are not certain whether silicone leaking out of an implant could be ingested by an infant during feeding.

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

How to Report Problems With Medical Products to the FDA

Breast implants do not last a lifetime and many women report complications that they did not expect. Many women with breast implants experience implant rupture, capsular contracture, breast or body pain, joint pain and other autoimmune symptoms, mental confusion, rashes, and even cancer of the immune system (ALCL). If you have experienced any of these complications, you could help other women by reporting it to the FDA.

The FDA is responsible for protecting patients and consumers by warning them about the risks of medical products, and taking products off the market if the risks outweigh the benefits.  The main way they gather information about the risks of breast implants (and other types of implants) is when doctors, nurses, and patients report problems through the FDA’s Voluntary MedWatch Report. If the FDA sees that complications are more serious or more frequent than expected, we will urge them to require manufacturers to conduct better research or to pull the product from the market.

You can report any problems caused by your breast implants using this short online form.

You don’t need to remember exactly when the symptoms or complications started, but give an estimate of how long it was after you got your implants.  If you don’t know the exact brand or model of your implant, you should report your problems anyway, but include the brand if you can.  From 2000 to 2015, most breast implants in the US were made  by either Mentor or Allergan (also called Inamed or McGhan).

If you prefer to report your problem over the telephone, you can do that by calling the at 1-800-FDA-1088.

If you are in Canada, you can report medical device complications to Health Canada using this short online form.

If you have problems completing the form, ask for help at info@center4research.org

 

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