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Implant Surgery Risks

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Like all surgery, implant surgery has some risks. Many of these risks are the same as the risks for mastectomy. However, there are some risks that are unique to implant reconstruction.

Scars: No matter which type of surgery you decide to have, you will have scars in the breast area. Scars do fade and recede over time in most women, but they don't go away completely. Still, most scars are generally out of sight during daily activities, even in a bathing suit or low-cut top or dress. Find out more about managing scar tissue formation.

Capsular contracture: Once a breast implant is in place, scar tissue forms around it, creating what's called a tissue capsule. These tissue capsules usually are soft or slightly firm and not noticeable. But in a small number of women, a hard tissue capsule forms that can be painful and distort the shape of the breast. This is called capsular contracture. Research has shown that implants with a textured surface can help reduce the risk of capsular contracture compared to implants with a smooth surface.

Radiation therapy given after reconstruction surgery can increase the risk of a scar tissue capsule forming. If you and your doctors decide that radiation therapy is right for you after you've had implant reconstruction, tell your radiation oncologist right away that you have an implant so you can minimize any risk.

If capsular contracture does happen, a surgeon can break up the scar tissue and replace the implant if necessary. The exercises your surgeon or physical therapist prescribes for you can help reduce the risk of a hard tissue capsule forming. Massage can also help. Ask your surgeon or nurse to show you how to massage the implant and the area around it to help prevent a hard tissue capsule. Learn more about capsular contracture.

Tissue breakdown: Sometimes the tissue in the breast area doesn't heal properly because of pressure from the implant or expander. The network of vessels that supply blood to the tissue could have been slightly damaged during surgery or radiation. Smoking and diabetes also can damage the small blood vessels that supply blood to the tissue and promote healing.

Doctors call this tissue breakdown “necrosis.” Some symptoms of tissue necrosis include pain and bleeding, the skin turning dark blue or black, numbness, and sores that ooze a bad-smelling discharge or pus. You also may run a fever or feel sick.

If tissue breakdown happens, the dead tissue will need to be removed and the open area has to be closed, either by regrowth of your own tissue or by using a dermal matrix product. In some cases, your surgeon may recommend a skin or tissue graft (taking skin or tissue from another place on your body) to cover or fill in the affected area.

There is also a high risk that the implant will have to be removed as a result of contamination.

Pain around implant: Some women feel pain or discomfort from the tissue expander, the implant, or scar tissue putting pressure on a nerve or other sensitive area. Your doctor may prescribe a program of exercise, stretching, and massage, and possibly anti-inflammatory medicines, to relieve mild pain. Acupuncture, breathing exercises, yoga, and meditation also can help. If you have pain that is intense, your doctor may recommend physical therapy, seeing a pain specialist, or stronger medicines.

“Dynamic distortion,” or distortion with movement: A breast reconstructed with an implant may move in unnatural ways as you flex your chest muscle (pectoralis muscle). Because the skin tends to scar down to the underlying muscle, any movement may cause distortion in the shape of the breast. Although this isn’t dangerous, some women find it uncomfortable or distressing -- especially if it wasn’t discussed as a possibility before surgery. Learn more about dynamic distortion.

Shifting, leaking: There's a small risk that your implant might shift slightly over time. If that happens, you may be able to massage it back into place. If your implant shifts a lot, schedule an appointment with your plastic surgeon to discuss ways to stop the problem. In some cases, your surgeon may have to build a reinforced pocket in your chest to hold the implant in place. This pocket is made from your own tissue and a dermal matrix product, if needed.

All implants have a slight risk of rupturing. The chance of your implant rupturing increases over time. Most implants that have been in place for 10 to 15 years have some leakage, but it's usually very small and not a problem.

If a saline implant ruptures, the saline leaks out quickly and the breast appears somewhat deflated, so you know immediately that it's ruptured. The salt water is absorbed by the body.

If a silicone implant ruptures, the gel leaks out more slowly because it's thicker, so it may take you longer to realize that the implant has ruptured, or you may not realize it at all. Silicone gel is not absorbed into the body and can show up on an MRI (magnetic resonance imaging) scan or sometimes on a regular X-ray. The FDA recommends that you receive MRI screening for “silent rupture” 3 years after receiving your implant and every 2 years after that for the rest of your life. Getting health insurance to cover this can be challenging, so you may have to work with your doctor’s office on this. If at any time you think your silicone implant is leaking, have your doctor check it. A leaking silicone implant should always be replaced. Your body may react to the silicone by forming more scar tissue, which might be uncomfortable or cause a distorted breast shape.

Breast implants and the risk of breast anaplastic large-cell lymphoma

In January 2011, the U.S. Food and Drug Administration (FDA) first reported a possible link between both saline and silicone breast implants and a very rare form of lymphoma — anaplastic large-cell lymphoma (ALCL) — in the tissue near the implant. Once a breast implant is in place, scar tissue forms around it, creating what's called a tissue capsule. ALCL can develop in and around the tissue capsule. The possible link came to light when a study identified 34 women diagnosed with ALCL in a breast with an implant. Because ALCL is incredibly rare, the researchers doing the study and the FDA took notice when these women were diagnosed.

In January 2018, a Dutch study estimated the risk of ALCL in women with breast implants to be:

  • 1 in 35,000 for women at age 50
  • 1 in 12,000 at age 70
  • 1 in 7,000 at age 75

The risk of ALCL is higher in women with textured implants, which have a bumpy surface, as opposed to smooth implants, according to the FDA. The material inside the implant — silicone or saline — doesn't seem to affect the risk of ALCL.

So while the risk of ALCL is low, women with breast implants, especially textured breast implants, do have a higher risk of the disease compared to women without breast implants.

Most of the women who have been diagnosed went to their doctors and were diagnosed with ALCL because fluid had collected around the implant (called a seroma) years after the implant was placed. In some cases, testing the seroma fluid led to the diagnosis. In other cases, ALCL was diagnosed after a mass was found in the breast or because the tissue capsule tightened (called capsular contracture) and caused discomfort or cosmetic problems.

Most ALCL associated with breast implants has been treated by removing the implant and the scar tissue capsule. Additional treatments such as radiation therapy and chemotherapy usually aren't needed but may be recommended in some cases.

In January 2019, a panel of expert oncologists and plastic surgeons from the National Comprehensive Cancer Network developed treatment guidelines for ALCL linked to textured breast implants.

On July 24, 2019, Allergan announced a global recall of Biocell textured breast implants and tissue expanders after the FDA requested the recall. Currently, 38 other countries have recalled the Biocell implant because of its link to ALCL.

On the same day, the FDA also updated the number of worldwide cases of ALCL associated with breast implants: 573 women have been diagnosed, and 33 women have died from the disease.

Of the 573 cases of ALCL, 481 are attributed to Allergan implants. Of the 33 deaths, the FDA reports that the implant maker was known for 13 women. Of these 13 women, 12 of them were confirmed to have an Allergan breast implant at the time of their ALCL diagnosis.

If you're considering implants, know that the FDA doesn't think that the possible link between implants and ALCL should discourage women from implant reconstruction. Still, it makes sense to talk to your doctor about the risks and benefits of implants, including the differences between textured and smooth implants.

If you have an implant, the FDA recommends:

  • regular monitoring for symptoms of ALCL
  • if you have no symptoms of ALCL, there is no need to remove the implant and no need to change your routine medical care and follow-up

If you have an implant and are concerned, don't hesitate to call your doctor. Definitely call your doctor if you have symptoms or problems with your implant, such as pain, lumps, swelling, or asymmetry, especially if these problems develop years after the implant was placed.

You also can report implant problems on the FDA MedWatch reporting site. Select the consumer/patient form link.

For more information on illness linked to breast implants and what is currently known, listen to our podcast episode with Frank DellaCroce, M.D., FACS.

CRBS

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