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by Dr. Gregory T. Lynam

Breast Implants

Breast implants are medical devices that are
implanted under the breast tissue or under
the chest muscle to increase breast size.

What are breast implants?

According to the Food and Drug Administration (FDA): Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation) or to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction). They are also used in revision surgeries, which correct or improve the result of an original surgery. There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled.

What are the current types of breast implants?

There are two basic types of breast implants for sale in the United States: saline and silicone gel. Both types have a silicone outer shell. They vary in size, shell thickness, shell surface texture, and shape (contour). Saline breast implants are filled with sterile salt water. Should the implant shell leak, a saline implant will collapse, and the saline will be absorbed and naturally expelled by the body. Saline breast implants provide a uniform shape, firmness and feel, and are FDA-approved for augmentation in women age 18 or older. Silicone breast implants are filled with silicone gel. The gel feels a bit more like natural breast tissue. If the implant leaks, the gel may remain within the implant shell, or may escape into the breast implant pocket. A leaking implant filled with silicone gel will not collapse. If you choose silicone implants, you may need to visit your plastic surgeon regularly to make sure the implants are functioning properly. An ultrasound or MRI screening can assess the condition of breast implants. Silicone breast implants are FDA-approved for augmentation in women age 22 or older. https://www.plasticsurgery.org/cosmetic-procedures/breast-augmentation/implants

What are the shapes/textures of breast implants?

Round breast implants have a tendency to make breasts appear fuller than form-stable implants. Higher profile options can achieve even more projection. Because round implants are the same shape all over, there is less concern about them rotating out of place. Smooth breast implants are the softest feeling. They can move with the breast implant pocket, which may give more natural movement. Smooth implants may have some palpable or visible rippling under the skin. Textured breast implants develop scar tissue to stick to the implant, making them less likely to move around inside of the breast and become repositioned. Texturing offers some advantage in diminishing the risk of a tight scar capsule.

https://www.plasticsurgery.org/cosmetic-procedures/breast-augmentation/implants

There are two main types of breast implants: smooth surfaced and textured. Texturing is required for anatomically shaped implants to stop them rotating. No confirmed cases of ALCL have been reported with round, smooth surface prostheses. The lymphoma seems exclusively associated with textured prostheses, and the risk is highest for more robustly textured or polyurethane covered implants. https://www.bmj.com/content/363/bmj.k5054

What is the difference between a smooth implant and a textured implant?

Smooth breast implants are covered by a smooth outer shell while textured breast implants are covered by a grained outer shell.

Are Breast Implants Safe?

According to the American Society of Plastic Surgeons, Breast implants are FDA-approved and safe devices that offer many quality-of-life benefits for women. Hundreds of thousands of patients each year opt for breast implants and report no adverse effects. When a possible association with a rare disease is reported, plastic surgeons follow the science to provide detailed, accurate information for full patient consent and decision making.

Breast implants are among the most studied medical devices in the world, and they will continue to be. Collaboration among the scientific community, patient advocacy groups and governments from around the world will continue to enhance the device and ensure the global plastic surgery community works together to keep all parties educated about the latest news and advancements to improve patient safety.

As noted, breast implants have been studied worldwide for decades, and the scientific literature shows no causal relationship between the device and autoimmune diseases. That’s not to say a patient could not have a negative reaction to any medical device, and if a woman desires to have her breast implants removed – for any reason – she should consult her plastic surgeon.

Breast implants remain an important option for breast reconstruction and augmentation. Like any medical device, breast implants carry a risk of complications, and in the event any complication develops, patients should consult their plastic surgeon to address it in a timely manner.

Patients considering breast implants should seek out a board-certified plastic surgeon to help weigh the benefits and potential risks to make the best possible decision.

BIA-ALCL: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare and highly treatable type of lymphoma that can develop around breast implants. Data show BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces. The current lifetime risk of BIA-ALCL is estimated to be 1:3817 – 1:30,000 for women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades. Since the initial case report in 1996, ASPS now recognize approximately 265 cases in the US and a total of 673 worldwide as of January 25, 2019.

Most patients with BIA-ALCL have an excellent prognosis following surgical removal of the breast implants and the surrounding scar tissue capsule. Continued follow-up after any breast implant surgery is suggested and important for patient health, but patients who notice pain, lumps, swelling, fluid collections or unexpected changes in breast shape, including asymmetry, should contact their plastic surgeon. In most cases, women diagnosed with BIA-ALCL observed changes in the look or feel of the area surrounding the implant greater than one year after their initial surgical sites were fully healed, and on average eight to ten years after receiving textured implants. https://www.plasticsurgery.org/patient-safety/breast-implant-safety

Know the Facts

According to the FDA, if you are considering breast implants, here are five tips:
Recognize that breast implants are not considered lifetime devices.The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery. The life of breast implants varies by person and can’t be predicted. That means everyone with breast implants will face additional surgeries—but no one can tell them when. And while a few people may keep their original implants for 20 to 30 years, that is not the common experience.Patients can also request additional surgeries to modify the aesthetic outcome, such as size or shape.

Review product labeling.The FDA advises that people look at the Summary of Safety and Effectiveness Data (SSED) for each implant to learn about their characteristics and the fillers used. SSEDs have been produced for all approved saline and silicone gel-filled breast implants. These summaries provide information on the indications for use, risks, warnings, precautions, and studies associated with FDA approval of the device. They also provide information on how often serious complications occurred. The most serious complications are those that lead to further surgeries, such as ruptures or capsular contracture.

The FDA advises health care providers to give people the full product labeling—all of the patient information from the manufacturer—for implants. Ask your surgeon for the most recent version of the labeling and read it carefully. If you have questions about any of these documents, talk to your surgeon.

Communicate with your surgeon.Surgeons must evaluate the shape, size, surface texture, and placement of the implant and the incision site for each person. Ask the surgeon questions about his or her experience in performing breast implant surgery, the surgical procedure, and the ways the implant might affect your life.

Also, tell the surgeon about previous surgeries and your body’s response—for example, whether surgeries resulted in a larger than expected amount of scar tissue—and discuss your expectations. This discussion helps the surgeon make operative decisions that achieve the desired appearance, including decisions about incision location and size as well as implant size, material, and placement. Many people have additional operations to change implant size. To achieve the best results after the first procedure, careful planning and reasonable expectations are necessary.

Learn about long-term risks.The FDA has identified an association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a type of non-Hodgkin’s lymphoma. People who have breast implants may have an increased risk of developing ALCL in the fluid or scar tissue surrounding the implant. Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells). BIA-ALCL appears to develop more frequently in individuals with textured implants than in people with smooth-surfaced implants. Remember, like other lymphomas, ALCL is a cancer of the immune system and not of breast tissue.

Although some women with implants may have experienced health problems such as connective tissue diseases (such as lupus and rheumatoid arthritis), trouble breastfeeding, or reproductive problems, current evidence does not support an association between breast implants and these conditions.

Know that monitoring is important.In general, follow your health care provider’s instructions on how to monitor your breast implants.

If you notice any unusual signs or symptoms, report these changes promptly to your health care provider. Also, follow your health care provider’s instructions for how to monitor your breast implants and for routine mammography screening for breast cancer. When you make your appointment, make sure to inform the mammography facility that you have breast implants so enough time is scheduled for your mammogram. Your health care provider may also recommend other tests, such as magnetic resonance imaging (MRI). The FDA recommends that people with silicone implants get MRI screenings to detect silent ruptures three years after their surgery and every two years after that.https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm338144.htm

Know the Risks

FDA-approved implants undergo extensive testing to establish reasonable assurance of safety and effectiveness.Nonetheless, there are risks associated with all breast implants, including:
• additional surgeries
• breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), a cancer of the infection-fighting cells (lymphocytes) of the immune system
• capsular contracture, which is scar tissue that squeezes the implant
• breast pain
• rupture (tears or holes in the shell) with deflation of saline and silicone gel-filled implants
• silent (without symptoms) rupture of silicone gel-filled implants
• infection

Note: The silicone used for breast implants is different than injectable silicone. Injectable silicone is not FDA approved for body contouring.

Should I have breast reconstructive surgery?

Whatever your age, relationship status, sexual activity, or orientation, you can’t predict how you will react to losing a breast. It’s normal to feel anxious, uncertain, sad, and mournful about giving up a part of your body that was one of the hallmarks of becoming a woman: a significant part of your sexuality, what made you look good in clothes, how you might have fed your babies. No one can ever take that away from you. Moving forward, you now have the opportunity to determine what you want to have happen next. But first you must do some careful thinking and delving into your feelings in order to figure out what is best for you. In this section, we’ll talk you through each of the reconstruction options, what’s involved, and any risks, as well as alternatives to reconstruction.

Asking yourself some questions can help you start to think about what type of reconstruction you want — if you want reconstruction at all:
• How important is rebuilding your breast to you?
• Can you live with a breast form that you take off and put on?
• Will breast reconstruction help you to feel whole again?
• Are you OK with having more surgery for breast reconstruction after mastectomy or lumpectomy?

It’s also important to know that while breast reconstruction rebuilds the shape of the breast, it doesn’t restore sensation to the breast or the nipple. Over time, the skin over the reconstructed breast can become more sensitive to touch, but it won’t be exactly the same as it was before surgery.https://www.breastcancer.org/treatment/surgery/reconstruction

How do I know if I have textured implants?

If you have a breast implant…don’t hesitate to call your doctor if you’re concerned. Definitelycall 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.

If you are considering breast reconstruction with an implant, talk to your doctor about the risks and benefits of implants, including the differences between textured and smooth implants.

Still, there are two questions that don’t have good answers:
• Does it make sense to leave an implant with no problems in place if the opposite breast had an implant and tissue capsule removed because of BIA-ALCL?
• Is it safe to replace an implant removed because of BIA-ALCL with a new implant?

More research is needed to address these issues.

It’s important to know that the FDA emphasized that the risk of ALCL in women with breast implants is extremely low. The FDA doesn’t think that the link should discourage women from implant reconstruction.

https://www.breastcancer.org/research-news/study-estimates-risk-of-rare-cancer-from-implants

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