Medical Devices

Risks and Complications of Breast Implants


Risks of Breast Implants

Some of the complications and adverse outcomes of breast implants include:

  • Additional surgeries, with or without removal of the device
  • Capsular contracture, scar tissue that forms around the implant and squeezes the implant
  • Breast pain
  • Changes in nipple and breast sensation
  • Rupture with deflation of saline-filled implants
  • Rupture with or without symptoms (silent rupture) of silicone gel-filled implants

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Implant Complications

The following is a list of local complications and adverse outcomes that occur in at least 1 percent of breast implant patients at any time. You may need non-surgical treatments or additional surgeries to treat any of these, and you should discuss any complication and necessary treatment with your doctor. These complications are listed alphabetically, not in order of how often they occur.

ComplicationDescription
AsymmetryThe breasts are uneven in appearance in terms of size, shape or breast level.
Breast Pain
Pain in the nipple or breast area
Breast Tissue Atrophy
Thinning and shrinking of the skin
Calcification/Calcium DepositsHard lumps under the skin around the implant. These can be mistaken for cancer during mammography, resulting in additional surgery.
Capsular ContractureTightening of the tissue capsule around an implant, resulting in firmness or hardening of the breast and squeezing of the implant if severe.
Chest Wall DeformityChest wall or underlying rib cage appears deformed.
DeflationLeakage of the saltwater (saline) solution from a saline-filled breast implant, often due to a valve leak or a tear or cut in the implant shell (rupture), with partial or complete collapse of the implant.
Delayed Wound HealingIncision site fails to heal normally or takes longer to heal.
ExtrusionThe skin breaks down and the implant appears through the skin.
HematomaCollection of blood near the surgical site. May cause swelling, bruising and pain. Hematomas usually occur soon after surgery, but can occur any time there is injury to the breast. The body may absorb small hematomas, but large ones may require medical intervention, such as surgical draining.
Iatrogenic Injury/DamageInjury or damage to tissue or implant as a result of implant surgery
Infection, including Toxic Shock SyndromeOccurs when wounds are contaminated with microorganisms, such as bacteria or fungi. Most infections resulting from surgery appear within a few days to a week, but infection is possible any time after surgery. If an infection does not respond to antibiotics, the implant may need to be removed
Inflammation/IrritationResponse by the body to an infection or injury. Demonstrated by redness, swelling, warmth, pain and or/loss of function.
Lymphedema or LymphadenopathySwollen or enlarged lymph nodes
Malposition/DisplacementThe implant is not in the correct position in the breast. This can happen during surgery or afterwards if the implant moves or shifts from its original location. Shifting can be caused by factors such as gravity, trauma or capsular contracture.
NecrosisDead skin or tissue around the breast. Necrosis can be caused by infection, use of steroids in the surgical breast pocket, smoking, chemotherapy/radiation, and excessive heat or cold therapy.
Nipple/Breast Sensation ChangesAn increase or decrease in the feeling in the nipple and/or breast. Can vary in degree and may be temporary or permanent. May affect sexual response or breast feeding.
PalpabilityThe implant can be felt through the skin.
Ptosis
Breast sagging that is usually the result of normal aging, pregnancy or weight loss.
Redness/BruisingBleeding at the time of surgery can cause the skin to change color. This is an expected symptom due to surgery, and is likely temporary.
RuptureA tear or hole in the implant's outer shell.
SeromaCollection of fluid around the implant. May cause swelling, pain and bruising. The body may absorb small seromas. Large ones will require a surgical drain.
Skin RashA rash on or around the breast.
Unsatisfactory Style/SizePatient or doctor is not satisfied with the overall look based on the style or size of the implant used.
VisibilityThe implant can be seen through the skin.
Wrinkling/RipplingWrinkling of the implant that can be felt or seen through the skin.

A complete list of complications, as well as information on rates for those complications can be found in the patient labeling for the approved breast implants, Labeling for Approved Breast Implants.

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Additional Surgeries

Breast implants are not lifetime devices. The longer you have breast implants, the more likely it is that complications will occur and you will need to have them removed. There is no guarantee that you will have a satisfactory cosmetic outcome from any reoperation.

The type of surgical procedure performed during a reoperation depends on the complication involved. You may need to have one or more reoperations over the course of your life due to one complication or a combination of local complications. More than one procedure may be performed in a single reoperation. Types of surgical procedures that may be performed in a reoperation include:

  • Implant removal, with or without replacement
  • Capsule removal or surgical release of the scar tissue around the breast implant
  • Scar or wound revision, such as surgical removal of excess scar tissue
  • Drainage of a hematoma by inserting a needle or tube through the skin to drain the collection of blood
  • Repositioning of the implant by surgically opening the incision and moving the implant
  • Biopsy/cyst removal by inserting a needle through the skin or cutting through the skin to remove a lump.

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Implant Removal Options

If you elect to have your breast implants removed, or if it is medically indicated, there are two primary methods for implant removal. Your plastic surgeon may choose to remove your implant alone and leave the scar tissue that surrounds your implant in your body, also called the scar capsule. This option requires less surgical dissection and may pose less risk of local complications such as bleeding. Alternatively, your surgeon may also surgically remove the scar capsule when your breast implant is removed. This is called “en-bloc resection”. You should discuss with your surgeon which method is best for your situation.

Removal of the implant(s), with or without replacement, is one type of reoperation. As many as 20 percent of women who receive breast implants for augmentation have to have their implants removed within 8 to 10 years. You may need to have your implant removed at some time over the course of your life because of one or more local complications.

After removal, some women do not choose to replace their implants. These women may have cosmetically undesirable dimpling, puckering, or sagging of their natural breasts.

The photograph below shows a 29-year-old woman 1 year after having her silicone gel-filled breast implants removed, but not replaced. Women with large breast implants, especially those inserted on top of the chest muscles (subglandularly), may have major cosmetic deformity if they choose not to replace them or to undergo additional reconstructive surgery.
 

Implant removal without replacement in augmentation patient.
Photo courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

Some insurance companies do not cover implant removal or implant replacement, even if the first implant surgery was covered.

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Capsular Contracture

Capsular contracture is the hardening of the breast around the implant. It can occur in the tissue surrounding one or both implants. This hardening causes the tissue to tighten, which can be painful.

Capsular contracture may be more common following infection, hematoma and seroma. However, the cause of capsular contracture is not known.

There are four grades of capsular contracture, known as Baker grades.

Baker Grading Scale

  • Grade I: Breast is normally soft and looks natural
  • Grade II: Breast is a little firm but looks normal
  • Grade III: Breast is firm and looks abnormal
  • Grade IV: Breast is hard, painful, and looks abnormal

Grades III and IV capsular contracture are considered severe, and may require reoperation. The surgical procedure usually involves removal of the implant with or without replacement of the implant. There is a possibility that capsular contracture could occur again after surgery to correct it.

The FDA has not cleared or approved any devices to treat or reduce the incidence of capsular contracture.

The picture below shows a Grade IV capsular contracture in the right breast of a 29-year- old woman 7 years after placement of silicone gel-filled breast implants.

Capsular contracture in augmentation patient
Photo courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

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Rupture and Deflation

Rupture is a tear or hole in the outer shell of the breast implant.

Some possible causes of rupture of breast implants include:

  • Capsular contracture
  • Compression during a mammogram
  • Damage by surgical instruments
  • Damage during procedures to the breast, such as biopsies and fluid drainage
  • Normal aging of the implant
  • Overfilling or underfilling of saline-filled breast implants
  • Physical stresses such as trauma or intense physical pressure
  • Placement through a non-FDA approved incision site, for example the belly button
  • Too much handling during surgery

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Saline-Filled Breast Implant Rupture and Deflation

The term rupture is used for all types of breast implants, but the term deflation is only used for saline-filled implants. You and/or your doctor will be able to tell if your saline-filled implant ruptures because the saline solution leaks into your body immediately or over several days. You will notice that your implant loses its original size or shape.

The following surgical procedures are not recommended for FDA-approved saline-filled breast implants because they are known to cause rupture and deflation:

  • Closed capsulotomy - a technique used to relieve capsular contracture involving manually squeezing the breast to break the hard capsule
  • Placement of drugs or other substances inside the implant other than sterile saline
  • Any contact of the implant with Betadine, a povidone-iodine topical antiseptic made by Purdue Frederick Company
  • Injection through the implant shell
  • Alteration of the implant
  • Stacking of the implants (more than one implant per breast pocket).

The photograph below shows a 30-year-old woman whose left saline-filled breast implant deflated. The implant is thought to have deflated due to a particular design, which is no longer used by the manufacturer.

Deflation in augmentation patient.
Photo courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

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Silicone Gel-Filled Implant Rupture

Silicone breast implants can rupture at any time after your implant surgery, but the longer an implant is in place, the greater the possibility an implant may rupture.

If a silicone gel-filled breast implant ruptures, it is not likely that you or your doctor will immediately notice because most silicone implant ruptures are without symptoms, “silent ruptures”. A silent rupture doesn't change the way an implant looks or feels, and your health care provider may not be able to detect a silent rupture by a physical examination alone. Magnetic resonance imaging (MRI) is the most effective method for detecting silent rupture of silicone gel-filled breast implants.

However, occasionally when a silicone gel-filled implant ruptures, a woman may notice a decrease in breast size, change in breast implant shape, hard lumps over the implant or chest area, an uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation.

Generally, when silicone gel-filled implants rupture, the silicone gel escapes through a tear or hole in the implant shell but remains confined within the scar tissue capsule around the implant, called an intra-capsular rupture. If the gel migrates beyond the scar tissue around the breast implant, it is called an extracapsular rupture. Sometimes, after a rupture, the gel moves to other distant areas around the body, which is called extracapsular rupture with gel migration. It may be difficult or impossible to remove silicone gel after a rupture.

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Connective Tissue Disease

The FDA has not detected any association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. In order to rule out these and other complications, studies would need to be larger and longer than those conducted so far.

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Systemic Symptoms (Breast Implant Illness (BII))

Symptoms such as fatigue, memory loss, rash, “brain fog,” and joint pain have been reported by some patients with breast implants. Some patients may use the term “breast implant illness” (BII) to describe these symptoms. Researchers are investigating these symptoms to better understand their origins. These symptoms and what causes them are poorly understood.

We encourage patients to report any injury, adverse event or symptom related to a medical device, including the symptoms listed above to the FDA, by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.  Please include the following information:

  • Device Name (Brand Name)
  • Manufacturer's Name
  • Details of Adverse Event and Medical and/or Surgical Interventions (if applicable)

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

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a T-cell lymphoma that can develop following breast implants. For additional information, see: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

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Breastfeeding

Some women who undergo breast augmentation can successfully breastfeed and some cannot. Women who undergo mastectomies and then have breast implant reconstruction surgeries may not be able to breastfeed on the affected side due to loss of breast tissue and the glands that produce milk.

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Effects on Children

At this time, it is not known if a small amount of silicone may pass through from the breast implant silicone shell into breast milk during breastfeeding. Although there are currently no established methods for accurately detecting silicone levels in breast milk, a study measuring silicon (one component in silicone) levels did not indicate higher levels in breast milk from women with silicone gel-filled implants when compared to women without implants.

In addition, concerns have been raised regarding potential damaging effects on children born to mothers with implants. Two studies in humans have found no increased risk of birth defects in children born to mothers who have had breast implant surgery. Although low birth weight was reported in a third study, other factors (for example, lower pre-pregnancy weight) may explain this finding.

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Things to Consider Before Getting Breast Implants

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There are several important things to consider before deciding to undergo breast implant surgery, including understanding your own expectations and reasons for having the surgery. Below are some things the FDA thinks you should consider before undergoing breast augmentation, reconstruction or revision surgery.

  • Breast implants are not lifetime devices; the longer you have your implants, the more likely it will be for you to have them removed.
  • The longer you have breast implants, the more likely you are to experience local complications and adverse outcomes.
  • The most common local complications and adverse outcomes are capsular contracture, reoperation and implant removal. Other complications include rupture or deflation, wrinkling, asymmetry, scarring, pain, and infection at the incision site.
  • You should assume that you will need to have additional surgeries (reoperations).
  • Many of the changes to your breast following implantation may be cosmetically undesirable and irreversible.
  • If you have your implants removed but not replaced, you may experience changes to your natural breasts such as dimpling, puckering, wrinkling, breast tissue loss, or other undesirable cosmetic changes.
  • If you have breast implants, you will need to monitor your breasts for the rest of your life. If you notice any abnormal changes in your breasts, you will need to see a doctor promptly.
  • If you have silicone gel-filled breast implants, you will need to undergo periodic MRI examinations in order to detect ruptures that do not cause symptoms (“silent ruptures”). For early detection of silent rupture, the FDA recommends that women with silicone gel-filled breast implants receive MRI screenings 3 years after they receive a new implant and every 2 years after that. MRI screening for implant rupture is costly and may not be covered by your insurance.
  • If you have breast implants, you have a risk of developing a type of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in the breast tissue surrounding the implant. BIA-ALCL is not breast cancer. Women diagnosed with BIA-ALCL may need to be treated with surgery, chemotherapy and/or radiation therapy.

Page Last Updated: 04/19/2019
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