Safety And Silicone Breast Implants
Quality control
A few years ago, there were concerns about the quality of the silicone used to fill breast implants. This happened because unapproved silicone was found in breast implants made in France by a company called Poly Implant Prostheses . PIP implants have not been used in the UK since 2010.
Breast implants used in the UK must be approved by the Medicines and Healthcare Products Regulatory Agency . This organisation is responsible for ensuring that medical devices, including breast implants, are safe and fit for use.
If you are concerned about having breast implants, it is important to discuss this with your surgeon before your operation. They will be able to tell you the type of implants they use and who makes them.
Breast implant associated anaplastic large cell lymphoma
Anaplastic large cell lymphoma is an extremely rare type of non-Hodgkin lymphoma that can sometimes affect the breast. Women with breast implants have an increased risk of developing ALCL in the tissue around an implant. This is called breast implant associated anaplastic large cell lymphoma . The risk of this is extremely small with implants currently in use. The risk varies with the type of implant used. It is important to talk with your reconstructive surgeon before deciding on implant surgery.
Prevention Diagnosis And Treatment Of Breast Cancer
Knowing what kind of care you could need at each level of your cancer diagnosis is important.
Preventive screening: A mammogram is the most effective screening tool for breast cancer. Other imaging studies, such as breast ultrasound and breast MRI , could also occur if a person has symptoms, has dense breasts, is considered high risk, or has an abnormality that is found by a mammogram.
How Will These Rules Likely Impact Patients
Women considering breast reconstructive surgery using implants at MSK are routinely informed of the risks and the benefits of breast implants. Our patients are also presented with the other options reconstruction with their own tissues or external prosthesis, for example that may be suitable. At MSK, we take pride in providing individualized treatment plans for each patient. Our doctors and nurses clearly explain the pros and cons of each procedure, empowering our patients to make the best possible choices for themselves.
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What Should You Do If You Have Implants
Talk to your doctor. Most experts donât recommend removing textured implants just because of their link to ALCL. But if you do have textured implants and youâre concerned, talk with your doctor.
Itâs important to watch for the signs of ALCL. It can show up anywhere in your body. But most women with breast implants get it near scar tissue where their implants are.
Check your breasts regularly for:
- Lumps or other changes in the shape of your breast
- Pain in or near your breast thatâs regular or constant
- A skin rash near your breast
- Hardening in your breast or new scar tissue
Also look for:
- Exhaustion, which can be a sign of a weak immune system
These can be signs that you have ALCL. But they can also be signs of other things, like a ruptured implant. Thatâs why itâs important to see your doctor right away if you notice changes in your breasts.
ALCL is usually curable, especially when itâs found early. To find out if you have ALCL, a doctor will do a needle biopsy and an imaging test, such as an ultrasound or mammogram. Early treatment usually involves removing the implant and any tissue that has cancer.
Show Sources
Mayo Clinic: âIs There Any Connection Between Breast Implants and Cancer? And If So, How Serious is the Risk?â âNon-Hodgkinâs Lymphoma.â
M.D. Anderson Cancer Center: âWomen: Breast implants and Cancer Risk,â âImplant-Associated Anaplastic Large Cell Lymphoma.â
Wire Localization To Guide Surgery
Sometimes, if the cancer in your breast cant be felt, is hard to find, and/or is difficult to get to, the surgeon might use a mammogram or ultrasound to guide a wire to the right spot. This is called wire localization or needle localization. If a mammogram is used you may hear the term stereotactic wire localization. Rarely, an MRI might be used if using the mammogram or ultrasound is not successful.
After medicine is injected into your breast to numb the area, a mammogram or ultrasound is used to guide a thin hollow needle to the abnormal area. Once the tip of the needle is in the right spot, a thin wire is put in through the center of the needle. A small hook at the end of the wire keeps it in place. The needle is then taken out. Once in the operating room, the surgeon uses the wire as a guide to find the part of the breast to be removed.
The surgery done as part of the wire localization may be enough to count as breast-conserving surgery if all of the cancer is taken out and the margins are negative. If cancer cells are found at or near the edge of the removed tissue , more surgery may be needed.
It should be noted that a wire-localization procedure is sometimes used to perform a surgical biopsy of a suspicious area in the breast to find out if it is cancer or not.
There are other ways a surgeon can be guided to the tumor, but these techniques are newer and not used in every facility.
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What Is Msks Recommendation For The Removal Of Textured Breast Implants
There is no scientific evidence that removing a textured device eliminates the risk of BIA-ALCL. However, some women may choose to remove their textured implant with or without the scar around it to minimize the concern regarding this risk.
Neither the FDA, nor the American Society of Plastic Surgeons, nor the American College of Surgeons recommends that women remove their Allergan textured breast implants.
What Type Of Follow
If you dont receive radiation therapy or chemotherapy, you may be asked to see your provider on a routine basis perhaps every three to six months for a couple of years. Your visits may include PET/CT scans every six to 12 months to check for signs of recurrence.
Follow-up care after radiation therapy or chemotherapy will depend on your progress. Your healthcare provider will monitor you closely to provide appropriate follow-up care.
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Radiation Therapy And Breast Reconstruction With Implants
If your treatment plan includes mastectomy, radiation therapy and breast reconstruction, discuss possible risks with your plastic surgeon and radiation oncologist.
Learn more about breast reconstruction.
New radiation therapy methods are under study in clinical trials.
Learn more about clinical trials.
Is The Breast Cancer Treatment Just As Effective
Of course. The presence of breast implants does not change the effectiveness of the treatment. There is a possible risk of aesthetic alterations, which needs to be avoided. An implant or prosthesis in itself implies a percentage of retractions. Radiation therapy should be done so that this percentage does not rise or does so to the smallest extent possible.
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Possible Reasons For Not Having An Implant Reconstruction
This type of reconstruction is not always recommended if you are having radiotherapy to the area. Radiation increases the risk of the implant becoming hard and might distort the shape of the breast. It can also make the skin less stretchy.
Your surgeon will talk to you about the options for reconstruction if you need radiotherapy.
You can’t have this type of reconstruction if you have had a radical mastectomy because the chest muscles will have been removed.
Have You Developed Symptoms
The most common symptoms are unexplained breast enlargement, asymmetry, fluid buildup or a lump in the breast or armpit, but may be rarely more subtle such as overlying skin rash, hardening of the breast. Women who develop these symptoms should see their physician to be evaluated with a physical exam and further testing.
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What Types Of Implants Are Used For Breast Reconstruction
Several types of breast implants can be used to rebuild the breast. Most implants in the US are made of a flexible silicone outer shell, and they can contain saline or silicone gel. Other types of implants that have different shells and are filled with different materials are being studied, but these are only available if you are taking part in a clinical trial.
It’s important to discuss the benefits and risks of the different types of implants with your doctor.
What Is Breast Implant
Breast implant-associated anaplastic large cell lymphoma is also called BIA-ALCL. Its a rare form of lymphoma that occurs in some people whove had breast implants. Its a type of immune system cancer and isnt breast cancer.
This type of lymphoma occurs in the fluid and scar tissue around the implant. In more advanced cases, it may spread to lymph nodes near your breast and in other parts of your body. It can also enter your chest wall underneath your breast.
BIA-ALCL generally grows slowly. Usually, healthcare providers treat it surgically by removing the breast implant and surrounding capsule. In rare cases, it can be fatal.
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Switching Insurance For Better Breast Cancer Benefits
In a perfect world, your health plan would cover all the facilities, providers, and treatments you want. In reality, not all plans are created equal. Treatments your healthcare provider recommends may or may not be covered.
It may be in your best interest to change to a plan that gives you more treatment options. However, you cannot switch plans whenever you want.
Unless you have a major life event that qualifies you for a special enrollment period , you can usually only change your plan once a year. This occurs during a designated period known as the open enrollment period. These are:
- Employer plans: Enrollment period varies by employer.
- Medicaid: Year-round enrollment is based on eligibility.
- Medicare: Open Enrollment is October 15 to December 7.
Make sure you know when your open enrollment period is, so you dont miss an opportunity to sign up for a plan that best meets your needs.
How Do Surgeons Reconstruct The Nipple And Areola
After the chest heals from reconstruction surgery and the position of the breast mound on the chest wall has had time to stabilize, a surgeon can reconstruct the nipple and areola. Usually, the new nipple is created by cutting and moving small pieces of skin from the reconstructed breast to the nipple site and shaping them into a new nipple. A few months after nipple reconstruction, the surgeon can re-create the areola. This is usually done using tattoo ink. However, in some cases, skin grafts may be taken from the groin or abdomen and attached to the breast to create an areola at the time of the nipple reconstruction .
Some women who do not have surgical nipple reconstruction may consider getting a realistic picture of a nipple created on the reconstructed breast from a tattoo artist who specializes in 3-D nipple tattooing.
A mastectomy that preserves a woman’s own nipple and areola, called nipple-sparing mastectomy, may be an option for some women, depending on the size and location of the breast cancer and the shape and size of the breasts .
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Surgery To Remove Breast Cancer
There are two main types of surgery to remove breast cancer:
- Breast-conserving surgery is surgery to remove the cancer as well as some surrounding normal tissue. Only the part of the breast containing the cancer is removed. How much breast is removed depends on where and how big the tumor is, as well as other factors. This surgery is also called a lumpectomy, quadrantectomy, partial mastectomy, or segmental mastectomy.
- Mastectomy is a surgery in which the entire breast is removed, including all of the breast tissue and sometimes other nearby tissues. There are several different types of mastectomies. Some women may also have both breasts removed in a double mastectomy.
Breast Reconstruction After Surgery
Many woman having surgery for breast cancer might have the option of breast reconstruction. A woman having a mastectomy might want to consider having the breast mound rebuilt to restore the breasts appearance after surgery. In some breast-conserving surgeries, a woman may consider having fat grafted into the affected breast to correct any dimples left from the surgery. The options will depend on each womans situation.
There are several types of reconstructive surgery, but your options depend on your medical situation and personal preferences. You may have a choice between having breast reconstruction at the same time as the breast cancer surgery or at a later time .
If you are thinking about having reconstructive surgery, its a good idea to discuss it with your breast surgeon and a plastic surgeon before your mastectomy or BCS. This gives the surgical team time to plan out the treatment options that might be best for you, even if you wait and have the reconstructive surgery later.
To learn about different breast reconstruction options, see Breast Reconstruction Surgery.
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Reporting Of Confirmed Cases
The U.S. Food and Drug Administration specifically recommends that all confirmed cases be reported to the PROFILE registry. The PROFILE registry is a joint effort of the FDA and ASPS/PSF. If you have been diagnosed with BIA-ALCL, please ensure your physician has reported the case to the PROFILE registry for tracking of cases. Information reported to PROFILE is updated with the FDA on a monthly basis. While PROFILE is a physician reporting system, if you would like to report your case directly, you may contact PSF who can get you in contact with a physician willing and able to report your case.
I Have Breast Implants
Breast-cancer treatment is challenging enough on its own, but what if you have cosmetic breast implants?
According to Charlene Laino of WebMD News, breast augmentation is the most common cosmetic procedure in the U.S. However, little research has focused on how implants may affect treatment.
As you may know, breast-cancer treatment usually involves one of two types of surgery: either a mastectomy, where the entire breast is removed, or a lumpectomy, where only the tumor is removed, radiation applied, and the rest of the breast reconstructed. For women with implants, a mastectomy typically involves an implant exchange, whereas a lumpectomy may or may not leave the implant intact.
So far, it seems that treatment outcomes are about the same for women with and without implants, at least as far as survival and recurrence rates are concerned. Mastectomy outcomes, as well, seem about equal. For women with implants, researchers say that in the early stages of the disease, mastectomy with reconstruction-particularly if radiation is not required-has very positive outcomes, with possible lowered sensitivity in the nipple area the only downside.
According to Robert Kuske, a clinical professor at the University of Arizona Health Sciences Center and radiation oncologist at Arizona Oncology Services in Scottsdale, AZ, about 55 percent of women with breast implants experience unwanted hardening of their implants after undergoing traditional whole-breast irradiation.
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What Factors Can Affect The Choice Of Breast Reconstruction Method
Several factors can influence the type of reconstructive surgery a woman chooses. These include the size and shape of the breast that is being rebuilt, the womans age and health, her history of past surgeries, surgical risk factors , the availability of autologous tissue, and the location of the tumor in the breast . Women who have had past abdominal surgery may not be candidates for an abdominally based flap reconstruction.
Each type of reconstruction has factors that a woman should think about before making a decision. Some of the more common considerations are listed below.
Reconstruction with Implants
- Enough skin and muscle must remain after mastectomy to cover the implant
- Shorter surgical procedure than for reconstruction with autologous tissue little blood loss
- Recovery period may be shorter than with autologous reconstruction
- Many follow-up visits may be needed to inflate the expander and insert the implant
Possible complications
Risks Of Illness From Breast Implants
In the past, there were concerns about possible health issues from ruptured silicone-filled implants, such as connective tissue disease, breast cancer, or reproductive problems. So far, studies show that silicone implants do not increase the risk of these health problems. Some people with breast implants may have symptoms of joint pain, memory loss, or fatigue. It is not clear if these symptoms are related to the breast implants and more research is being done.
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Finding Out Breast Cancer Coverage With An Existing Policy
When the Affordable Care Act was passed in 2010, it required that insurance plans cover 10 essential health benefits. Those benefits included the services needed to treat serious conditions like cancer.
Screening mammograms were made free, and ambulatory care , hospital care, laboratory tests, prescription drug coverage , and rehabilitation services were included in all plans.
Unfortunately, not all health plans have to follow the ACA rules. Individual private plans and small group plans do. However, plans that existed before the ACA and large-group plans do not. Depending on the type of insurance you have, your cancer coverage may vary.