Category Archives: What You Need To Know

Questions to Ask Your Surgeon Before Breast Reconstruction

If you’re considering breast reconstruction after breast cancer treatment, it can be hard to know what questions to ask. The first question is one that you need to discuss with your oncologist, not with a plastic surgeon: Should I get a mastectomy or a lumpectomy?

It is important to realize that women undergoing lumpectomy for early-stage breast cancer live at least as long – possibly longer – than those who undergo a mastectomy. It is also important to understand that if you have a mastectomy with reconstruction, your breasts will be numb – you will not have any feeling.

If you are seriously considering mastectomy with reconstruction, you will want to consider the different options for reconstruction:  breast implants or reconstruction with fatty tissue from your tummy or back (that’s called autologous tissue transfer). Here is more information about those options: http://www.breastimplantinfo.org/diagnosed-breast-cancer-options-breasts-3/.

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

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 ALCL1. 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 implant2. 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 bacteria3. Most cases of BIA-ALCL have been reported in women with textured implants, which provide a better surface for bacteria to grow.

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.  By 2016, BIA-ALCL was widely recognized by cancer experts, but not all oncologists 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 ALCL.

Is BIA-ALCL really rare?

The U.S. Food and Drug Administration (FDA) says that it has received 359 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 ALCL4.

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. However, 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, or an “en bloc” removal. 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.

References

  1. FDA, Center for Devices and Radiological Health. (2017). Breast Implants – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm
  2.  Swerdlow, S. H., Campo, E., Pileri, S. A., Harris, N. L., Stein, H., Siebert, R., et al. (2016). The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood, 127, 2375-2390. doi:10.1182/blood-2016-01-643569
  3.  Kadin, M. E., Deva, A., Xu, H., Morgan, J., Khare, P., Macleod, R. A., Epstein, A. L., et al. (2016). Biomarkers Provide Clues to Early Events in the Pathogenesis of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Aesthetic Surgery Journal, 36(7), 773-781. doi:10.1093/asj/sjw023
  4. Therapeutic Goods Administration. (2017). Breast implants and anaplastic large cell lymphoma. Retrieved from https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma

Autoimmune Concerns after Reconstructive Surgery

Breast implant companies were required to complete safety studies before they could sell their implants in the United States. Although the Food and Drug Administration (FDA) approved breast implants, they admitted that women using breast implants for reconstruction had more complications than healthy women with cosmetic breast implants, and that “studies would need to be larger and longer” to find out if implants could cause the kinds of diseases many women were reporting.1

Since many women reported problems with autoimmune symptoms such as joint pain, breast implant companies did not study the safety of implants in women who had a family history or personal history of autoimmune disease before getting implants. They intentionally excluded those women because they were concerned that 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: 2

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 disease is a condition where immune cells attack your body. Immune cells usually help our bodies fight off infections and foreign substances. However, these immune cells see silicone as a foreign substance, and that can cause the body to start an immune response.

Cancer treatments can harm a patient’s immune system, but not in the same way as an autoimmune disease.

In some cases, the immune system launches a big enough attack that it starts attacking the body. This could lead to symptoms like joint pain, fatigue, mental confusion, dry eyes, and hair loss. Some women with breast implants report a wide range of symptoms that do not fit into one specific condition. Over time, some women develop a pattern of symptoms that are diagnosed as lupus, scleroderma, or other conditions. Autoimmune diseases can target specific organs, like the brain or liver. They can also involve many tissues, like muscles or blood.3

It is important to know that not all people who get breast implants develop immune problems. Those who develop autoimmune symptoms may have other risk factors, such as allergies or a family history of autoimmune disease3,4.  In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms 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. In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms after getting breast implants.

Silicone-related complaints and diagnoses (modified from DeBoer et al, 2011) 4

 

 

Silicone-related complaints

  • Fatigue
  • Muscle aches
  • Aching and painful joints
  • Fever/elevated body temperature
  • Dry eyes, dry mouth (sicca)
  • Poor memory, concentration, or sleep
  • Stroke
  • Numbness, weakness, dizziness, vision changes (Multiple sclerosis)
 

 

  Silicone-related diagnoses

  • Raynaud’s disease (painful cold, pale, or purplish fingers and toes)
  • Irritable bowel syndrome (diarrhea, constipation)
  • Allergies (food allergies, metal allergies, multiple sensitivities, etc.)
  • Immunodeficiencies (recurrent infections, e.g., pneumonia, sinus infections, diarrhea)
  • Autoimmune diseases (Scleroderma, Lupus, Sjogren’s, etc.)

How “good” is the evidence?

There is conflicting evidence from studies that examined whether breast implants cause autoimmune disease or symptoms. Most studies were funded by implant companies or plastic surgery associations, and they tend to focus on narrowly defined diagnoses, with numerous studies based on hospital records rather than medical records. However, many women with breast implants have reported the same complaints over the last few decades, and many women report that their symptoms greatly improved or completely disappeared after their implants were removed.3, 4, 6

In 2001, FDA scientists reported that women with leaking silicone gel implants were nearly 3 times more likely to have fibromyalgia. 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.3         

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 research was needed to determine if breast implants caused specific symptoms or diseases.5

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.

The Bottom Line

Although well-designed large, long-term studies are lacking, women with implants and autoimmune symptoms have reported for decades that their symptoms improved when their implants were removed. A Dutch study found that among 52 women who had their implants removed, 36 (69%) reported that they felt better, and 9 of the 36 reported that their symptoms were gone.6 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.4

However, the prognosis might be better for women with autoimmune symptoms who have their implants removed than for women with a diagnosed autoimmune disease.4

Treatments and Alternatives 3,4

Here are some symptoms that many women have reported to have developed after getting breast implants.  Some of these symptoms developed almost immediately, but others developed years later.

  • I have achy, sore, or weak muscles.
  • I have achy or stiff joints.
  • I wake up every morning feeling tired or un-refreshed, and no matter how much I sleep, I never feel well-rested.
  • I feel like my head is in a “fog.” I have difficulty concentrating, finding the right word to say, or remembering things.
  • I feel warm or hot even when it’s cold outside.
  • I have dry skin, dry eyes, or hair loss.

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 the silicone implant. If you already have breast implants and have any of the above symptoms, here are some steps to consider:

  • See a rheumatologist. A rheumatologist is a specialist of joint and immune system conditions. The rheumatologist can examine you and order tests if necessary to potentially diagnose any conditions. See a provider you trust and don’t be afraid to get a second opinion. This is your right as a patient!
  • Your doctor may offer you medications to treat your symptoms. For example, he/she may offer you artificial tears to help with dry eyes or suggest medications to decrease inflammation in your body.

References

  1. U.S. FDA. Medical Devices: Breast Implants: Risks of Breast Implants. (Apr. 4, 2017). Available Online:https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064106.htm#Connective_Tissue_Disease
  2. Mentor. Mentor Silicone Gel-Filled Breast Implant Product Insert Data Sheet. (Nov. 2006). Available online: https://www.accessdata.fda.gov/cdrh_docs/pdf3/p030053c.pdf
  3. Cohen Tervaert JW, Colaris MJ, van der Hulst RR. Silicone breast implants and autoimmune rheumatic diseases: myth or reality. Curr Opin Rheumatol. 2017 Jul;29(4):348-354. doi: 10.1097/BOR.0000000000000391.
  4. de Boer M, Colaris M, van der Hulst RRW, Cohen Tervaert JW.Is explantation of silicone breast implants useful in patients with complaints? Immunol Res. 2017 Feb;65(1):25-36. doi: 10.1007/s12026-016-8813-y
  5. Brinton LA, Buckley LM, Dvorkina O et al. Risks of connective tissue disorders among breast implant patients. American Journal of Epidemiology. 2004; 180: 619-27.
  6. Maijers MC, et al. Women with silicone breast implants and unexplained systemic symptoms: a descriptive cohort study. The Netherlands Journal of Medicine. 2013; 71(10): 534-540. Available online: http://www.njmonline.nl/getpdf.php?id=1392

Capsular Contracture After Reconstructive Surgery

The most common complication of breast implants is capsular contracture. When you get breast implants, your body naturally responds by forming scar tissue around the implants. Capsular contracture occurs when the scar tissue tightens around the breast implant. This can cause the implant to harden and become very painful. It can also change the shape of the breast, making it look abnormal, as shown in the photo below. The photo below is of a breast augmentation patient, but capsular contracture is even more common and often more extreme among reconstruction patients.

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.

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). It 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. If you have any breast tissue, it might need to be removed during the surgery because it is attached to the scar tissue.

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

Ruptured Implants After Reconstructive Surgery

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. And you will want to talk to the doctor about your options to remove or replace your implant.

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 silicone has moved to other parts of your body, it can’t be removed and may cause other health problems.

If you have two breast implants and one ruptures, you should consider removing them both at the same time, whether or not you want them 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. If it is possible to do both at once, that will reduce the number of surgeries you will need.

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 leaking1. One study found that 3 out of every 4 women who removed their silicone breast implants saw improvement in their symptoms2. 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.

A summary of possible symptoms of ruptured implants is below.

Saline Implant Rupture Silicone Gel Implant Rupture
What happens? Implant usually leaks saline very quickly into the body Implant usually leaks silicone gel slowly into the scar tissue or into the breast area and can migrate elsewhere in the body
How do I know if it has ruptured? Implant will visibly “deflate” and change in shape or size Sometimes rupture is obvious but often there are no symptoms. Women need regular MRIs to screen for implant ruptures. Mammography is not accurate for detecting rupture or leaks.
Is there harm from rupture? Rupture is usually harmless, but you should consult with a doctor if you start to feel sick or develop a fever, rash, or other symptoms Women sometimes report a burning pain from leaking silicone, or they may notice small lumps (granulomas). Serious health risks such as fibromyalgia or several other diseases have been reported in research and by many women.

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

References

  1. Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol. 2001;28(5):996-1003
  2. de Boer M, Colaris M, van der Hulst RRW, Cohen Tervaert JW.Is explantation of silicone breast implants useful in patients with complaints? Immunol Res. 2017 Feb;65(1):25-36. doi: 10.1007/s12026-016-8813-y.

The Costs of Revising or Removing Breast Implants

Breast implant complications are common. Based on studies conducted by implant companies, the FDA concluded that between 20-40% of augmentation patients required at least one additional implant surgery within 8-10 years1. These revision surgeries often cost as much as the initial surgery, if not more. Revision surgeries might involve replacing implants or correcting the visual appearance of breast implants. Since many women dropped out of the implant companies’ studies, the proportion of women needing additional surgery could be much higher. You can read more about possible breast implant complications here.

If problems with your breast implants are bad enough or can’t be fixed, it may be necessary to remove your implants.

In 2016, the average surgeon’s fee for removal of breast implants was $2,506, but that does not include all the costs of surgery2. Our review of various plastic surgery websites revealed that the total average cost for breast implant removal is $5,000-$7,000. You can expect to pay an additional $2,500-$3,500 if you choose to replace your implants or about $5,000 if you choose to have a breast lift. A breast lift is a one-time expense but the replacement implants are likely to need to be replaced in later years. The cost of removal varies by surgeon, geographic region, and the complexity of the procedure.

Implant companies admit that breast implants will not last a lifetime. When saline implants leak, it is obvious because they deflate quickly, so the breast looks smaller. When silicone gel breast implants leak, there often are no symptoms at first. Silicone can leak out of the hole in the implant and travel to parts of the body where surgeons can’t remove it. Leaking silicone could cause pain, burning, and allergic or autoimmune reactions. These symptoms may result in additional medical costs. Removal of breast implants can be very expensive, especially if they are leaking silicone gel. In fact, some patients have reported paying $20,000 or more.

Due to concerns about leaking silicone, the FDA recommends that women with silicone gel breast implants get an MRI to check for leakage after 3 years — and then every other year after that. Unfortunately, a breast MRI costs about $2,000, and sometimes more. Though the MRI scan is expensive, it is the most accurate way to know if your implants are leaking. Your insurance plan might not cover things like an MRI or consultations with your doctor, so expect to pay for it yourself. If they are leaking, it is important to have them removed as soon as possible. You can read more about removing breast implants here.

Some insurance companies do not cover the costs of removal if your implants were placed for cosmetic reasons. Insurance plans that do cover removal require that patients prove that explant surgery is medically necessary. Symptoms that are considered medically necessary reasons for breast implant removal include rupture, capsular contracture (Baker level III or IV), infection, and chronic pain. You will also need a doctor to advocate for you and communicate to your insurance company that removal is medically necessary. You can read more about trying to get insurance coverage for your breast implant removal here.

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

References

  1. Food and Drug Administration. Breast Implants: Local Complications and Adverse Outcomes. Retrieved from https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM548169.pdf
  2. American Society of Plastic Surgeons. Breast augmentation cost. Retrieved December 20, 2017, from https://www.plasticsurgery.org/cosmetic-procedures/breast-augmentation/cost

Autoimmune Symptoms and Breast Implants

Breast implant companies were required to complete safety studies before they could sell their implants in the United States. Although the Food and Drug Administration (FDA) approved breast implants, they admitted that “studies would need to be larger and longer” to find out if implants could cause the kinds of diseases many women were reporting.1

Since many women reported problems with autoimmune symptoms such as joint pain, breast implant companies did not study the safety of implants in women who had a family history or personal history of autoimmune disease before getting implants. They intentionally excluded those women because they were concerned that 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: 2

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 disease is a condition where immune cells attack your body. Immune cells usually help our bodies fight off infections and foreign substances. However, these immune cells see silicone as a foreign substance, and that can cause the body to start an immune response.

In some cases, the immune system launches a big enough attack that it starts attacking the body. This could lead to symptoms like joint pain, fatigue, mental confusion, dry eyes, and hair loss. Some women with breast implants report a wide range of symptoms that do not fit into one specific condition. Over time, some women develop a pattern of symptoms that are diagnosed as lupus, scleroderma, or other conditions. Autoimmune diseases can target specific organs, like the brain or liver. They can also involve many tissues, like muscles or blood.3

It is important to know that not all people who get breast implants develop immune problems. Those who develop autoimmune symptoms may have other risk factors, such as allergies or a family history of autoimmune disease3,4.  In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms 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. In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms after getting breast implants.

Silicone-related complaints and diagnoses (modified from DeBoer et al, 2011) 4

 

 

Silicone-related complaints

  • Fatigue
  • Muscle aches
  • Aching and painful joints
  • Fever/elevated body temperature
  • Dry eyes, dry mouth (sicca)
  • Poor memory, concentration, or sleep
  • Stroke
  • Numbness, weakness, dizziness, vision changes (Multiple sclerosis)
 

 

  Silicone-related diagnoses

  • Raynaud’s disease (painful cold, pale, or purplish fingers and toes)
  • Irritable bowel syndrome (diarrhea, constipation)
  • Allergies (food allergies, metal allergies, multiple sensitivities, etc.)
  • Immunodeficiencies (recurrent infections, e.g., pneumonia, sinus infections, diarrhea)
  • Autoimmune diseases (Scleroderma, Lupus, Sjogren’s, etc.)

How “good” is the evidence?

There is conflicting evidence from studies that examined whether breast implants cause autoimmune disease or symptoms. Most studies were funded by implant companies or plastic surgery associations, and they tend to focus on narrowly defined diagnoses, with numerous studies based on hospital records rather than medical records. However, many women with breast implants have reported the same complaints over the last few decades, and many women report that their symptoms greatly improved or completely disappeared after their implants were removed.3, 4, 6

In 2001, FDA scientists reported that women with leaking silicone gel implants were nearly 3 times more likely to have fibromyalgia. 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.3         

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 research was needed to determine if breast implants caused specific symptoms or diseases.5

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.

The Bottom Line

Although well-designed large, long-term studies are lacking, women with implants and autoimmune symptoms have reported for decades that their symptoms improved when their implants were removed. A Dutch study found that among 52 women who had their implants removed, 36 (69%) reported that they felt better, and 9 of the 36 reported that their symptoms were gone.6 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.4

However, the prognosis might be better for women with autoimmune symptoms who have their implants removed than for women with a diagnosed autoimmune disease.4

Treatments and Alternatives 3,4

Here are some symptoms that many women have reported to have developed after getting breast implants.  Some of these symptoms developed almost immediately, but others developed years later.

  • I have achy, sore, or weak muscles.
  • I have achy or stiff joints.
  • I wake up every morning feeling tired or un-refreshed, and no matter how much I sleep, I never feel well-rested.
  • I feel like my head is in a “fog.” I have difficulty concentrating, finding the right word to say, or remembering things.
  • I feel warm or hot even when it’s cold outside.
  • I have dry skin, dry eyes, or hair loss.

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 the silicone implant. If you already have breast implants and have any of the above symptoms, here are some steps to consider:

  • See a rheumatologist. A rheumatologist is a specialist of joint and immune system conditions. The rheumatologist can examine you and order tests if necessary to potentially diagnose any conditions. See a provider you trust and don’t be afraid to get a second opinion. This is your right as a patient!
  • Your doctor may offer you medications to treat your symptoms. For example, he/she may offer you artificial tears to help with dry eyes or suggest medications to decrease inflammation in your body.

References

  1. U.S. FDA. Medical Devices: Breast Implants: Risks of Breast Implants. (Apr. 4, 2017). Available Online:https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064106.htm#Connective_Tissue_Disease
  2. Mentor. Mentor Silicone Gel-Filled Breast Implant Product Insert Data Sheet. (Nov. 2006). Available online: https://www.accessdata.fda.gov/cdrh_docs/pdf3/p030053c.pdf
  3. Cohen Tervaert JW, Colaris MJ, van der Hulst RR. Silicone breast implants and autoimmune rheumatic diseases: myth or reality. Curr Opin Rheumatol. 2017 Jul;29(4):348-354. doi: 10.1097/BOR.0000000000000391.
  4. de Boer M, Colaris M, van der Hulst RRW, Cohen Tervaert JW.Is explantation of silicone breast implants useful in patients with complaints? Immunol Res. 2017 Feb;65(1):25-36. doi: 10.1007/s12026-016-8813-y
  5. Brinton LA, Buckley LM, Dvorkina O et al. Risks of connective tissue disorders among breast implant patients. American Journal of Epidemiology. 2004; 180: 619-27.
  6. Maijers MC, et al. Women with silicone breast implants and unexplained systemic symptoms: a descriptive cohort study. The Netherlands Journal of Medicine. 2013; 71(10): 534-540. Available online: http://www.njmonline.nl/getpdf.php?id=1392

The Costs of Getting Breast Implants

If you are thinking about getting breast implants, you should be fully aware of the initial and ongoing costs. According to 2016 data from the American Society of Plastic Surgeons, the average breast augmentation surgery costs $3,7191. That average cost only includes the plastic surgeon’s fee. It does not include fees for anesthesia, the operating room, or other surgical expenses like bandages or stitches. After all the fees, the surgery usually costs between $5,000 to $8,000. This price includes a follow-up visit after the surgery. Silicone gel breast implants usually cost about $1,000 more than saline implants. If you are considering augmentation, you can request an itemized bill before your surgery to see what all of the costs will be.

If you’re wondering whether you can afford breast implants, there are other costs to be aware of. For example, you may need additional funds for any complications from the implant, such as infection, rupture, pain, or asymmetry. Complication rates for breast augmentation surgeries are higher than you might think. The FDA found that between 20-40% of augmentation patients required at least one revision surgery within 10 years2. The FDA says that all women getting breast implants should assume that they will require additional surgeries3.

Because these additional surgeries can cost as much — if not more — as the initial surgery, we suggest that women considering breast implants make sure they have at least $5,000-8,000 saved in case any problems arise.

It is important to know that most insurance companies will not cover the costs of breast augmentation surgery. In addition, if you have problems with your breast implants, your insurance plan might not cover things like an MRI, consultations with your doctor, antibiotics, etc. If it is medically necessary to get your implants removed, many insurance companies do not cover the costs of removal if your implants were placed for cosmetic reasons. You can read more about the costs of revision and removal surgeries here.

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

References

  1. American Society of Plastic Surgeons. Breast augmentation cost. Retrieved December 20, 2017, from https://www.plasticsurgery.org/cosmetic-procedures/breast-augmentation/cost
  2. FDA, Center for Devices and Radiological Health. (2011). FDA Update on the Safety of Silicone Gel-Filled Breast Implants Executive Summary. Retrieved from https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260139.pdf.
  3. Food and Drug Administration. Breast Implants: Local Complications and Adverse Outcomes. Retrieved from https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM548169.pdf

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.

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 leaking1. One study found that 3 out of every 4 women who removed their silicone breast implants saw improvement in their symptoms2. 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.

A summary of possible symptoms of ruptured implants is below.

Saline Implant Rupture Silicone Gel Implant Rupture
What happens? Implant usually leaks saline very quickly into the body Implant usually leaks silicone gel slowly into the scar tissue or into the breast area and can migrate elsewhere in the body
How do I know if it has ruptured? Implant will visibly “deflate” and change in shape or size Sometimes rupture is obvious but often there are no symptoms. Women need regular MRIs to screen for implant ruptures. Mammography is not accurate for detecting rupture or leaks.
Is there harm from rupture? Rupture is usually harmless, but you should consult with a doctor if you start to feel sick or develop a fever, rash, or other symptoms Women sometimes report a burning pain from leaking silicone, or they may notice small lumps (granulomas). Serious health risks such as fibromyalgia or several other diseases have been reported in research and by many women.

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

References

  1. Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol. 2001;28(5):996-1003
  2. de Boer M, Colaris M, van der Hulst RRW, Cohen Tervaert JW.Is explantation of silicone breast implants useful in patients with complaints? Immunol Res. 2017 Feb;65(1):25-36. doi: 10.1007/s12026-016-8813-y.

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 by forming scar tissue around the implants. Capsular contracture occurs when the scar tissue tightens around the breast implant. This can cause the implant 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.

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). It can also interfere with daily activities, such as reaching above your head.

The same 29-year-old woman as above one year after her implants were removed and not replaced. Think of how much pain she was in to be willing to look like this! Photo courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

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.

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