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Do Breast Implants Cause Cancer

Helping Your Ob/gyn Identify Alcl

Do Breast Implants Increase Cancer Risk?

Dr. Agarwal: Right. So patients who’ve had breast implants can present to their physician, OB/GYN, general family physician, or their plastic surgeon with a variety of different complaints. The breast is swollen, it’s become more painful, or they feel a mass. The most common presentation is fluid around the implant. And about 86 percent to 90 percent of patients who’ve had this ALCL presented with what we call an effusion or a seroma around the implant.

Dr. Jones: Was it years after their implant or . . . it must have been years because cancer doesn’t happen in a day.

Dr. Agarwal: Right. So the average time to presentation of the 400 to 500 patients that have had this has been 8 to 10 years after the breast implant has gone in.

Dr. Jones: Right. So if it’s 400 in the U.S., that means the vast majority of plastic surgeons, OB/GYNs, primary care docs, nurse practitioners have never seen this, have never heard of it. But if a patient comes with a new complaint some years after the breast implant should be pretty stable, they should know enough to say, “That’s not normal.”

Dr. Agarwal: That’s correct. Again, to put it in a little bit of context, as you mentioned in your opening, there are about 300,000 to 500,000 breast implants that are placed annually in the United States. It’s believed that worldwide there are about 35 million women who have textured implants, and it’s believed worldwide about 1.5 million implants are placed annually.

Breast Implants After Mastectomy: Risks You Need To Know

The complication rate for getting breast implants after mastectomy has been described by experts as alarmingly high and arguably unacceptable,1 even though most of the information about complications is based on studies that were paid for by companies that make breast implants or silicone.

How safe are breast implants and how many women have complications after getting reconstruction with breast implants after a mastectomy? When the Food and Drug Administration approved breast implants, they acknowledged that the complication rate is very high for all women, especially those undergoing reconstruction after a mastectomy. What the FDA did not know, however, is that early-stage breast cancer patients that undergo mastectomy and reconstruction with breast implants are 10 times as likely to commit suicide as other early-stage breast cancer mastectomy patients.

Complications from Implants

We do not know why the suicide rate is so high for mastectomy patients with breast implants, but we do know that complications are very common. For example, a study conducted by implant manufacturer Inamed found that 46% of reconstruction patients needed additional surgery within the first 2 to 3 years after getting silicone gel breast implants 2. Not surprisingly, the implant maker did not publish an article describing this high complication rate, which was more than twice as high as the 21% reported in a study funded by a company that makes silicone .1

What Is The Treatment And Prognosis For Breast Implant Associated Cancer

It is usual that care is provided by a multi-disciplinary team. A treatment plan may be developed with advice from a blood disease specialist with experience in lymphoma, a cancer specialist, and a surgeon with breast implant experience.

In about 80% of cases, the disease is detected in the early stage, with cancer cells found only in the fluid surrounding the implant. Most of these cases are cured by removal of the implant and surrounding capsule. Over the last 10 years, four Australian women have died from breast implant-associated lymphoma.

Usually, both implants are removed even if breast implant-associated ALCL has only occurred in one breast. This is because there is a small but real risk that breast implant-associated ALCL can develop in the opposite breast. If there is a solid lump or the cancer has spread, the patient may require additional treatment such as chemotherapy, radiotherapy or additional surgery. Follow up monitoring may require additional CT scans.

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Anger Over Uk’s Failure To Ban Breast Implants Linked To 61 Cancer Cases

Exclusive: solicitors call for UK ban of textured variety associated with lymphoma

At least 61 women in the UK have been diagnosed with a potentially fatal cancer linked to breast implants, but the type they received continues to be used, with no plans by the regulator to follow France and Australia in banning them.

Lawyers for more than 40 of the women, who are bringing legal action against the manufacturers as well as the clinics and doctors who carried out the surgery, say the textured implants linked to anaplastic large cell lymphoma should be withdrawn from the market. Smooth implants are available instead, which have no proven connection to the cancer of the white blood cells.

The Medicines and Healthcare Products Regulatory Agency says the disease is very rare, but Sarah Moore, a solicitor at Leigh Day law firm, believes there are more cases than the regulator is aware of. I think there has been misdiagnosis and under-diagnosis, and I think we have to bear in mind that in the last 18 months there have been 17 more reported cases of ALCL, she said.

There is now greater patient awareness and as a result, I think women are pushing for diagnosis. I think were going to see a significant increase in diagnosis, unfortunately.

France and Australia have since banned the sales of all textured implants, although neither has suggested that women should actively seek to have them removed.

Allergan Will Provide Replacement Implants Free Of Charge

Breast Implants Can Cause Rare Form of Cancer, FDA Says

Under its lifetime warranty for textured breast implants, Allergan states it will replace recalled products with smooth breast implants at no charge to women who opt to have the textured implants removed. This warranty covers the product only. Allergan will not reimburse you for surgical costs.

In general, women with Allergan textured breast implants need not panic over the current recall. Instead, you should consult your doctor for an examination to learn if your implants seem healthy, and you should monitor your breast health as normal, but with a special vigilance for the signs and symptoms of BIA-ALCL.

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Breast Implants And Cancer Of The Immune System : A History Of Who Knew What When

Experts now agree that breast implants can cause a type of cancer of the immune system known as anaplastic large cell lymphoma . The Food and Drug Administration finally admitted this risk of cancer in 2017, but other experts including plastic surgeons were aware of the risk years before. 1 Why did it take so long for the FDA, the media, and women with implants to find out that choosing breast implants could increase their chances of developing a potentially fatal disease?

Anaplastic large cell lymphoma is a rare type of cancer of the immune system that was estimated to affect 1 in half a million women. 2 It usually develops in the lymph nodes, skin, lungs, or liver. However, ALCL sometimes develops in the breast area of women with breast implants.

In 2008, Dutch researchers published a report of 11 women with breast implants and ALCL, and concluded that the implants seemed to be associated with ALCL.3 Although published in the Journal of the American Medical Association , this information was not widely reported.

And yet, it was not until March 2017 that the FDA finally updated its website to officially report that breast implants could cause ALCL. At the time of the FDA announcement, the agency reported that they had received 359 reports of ALCL among women with breast implants. Reports to the FDA of problems from medical devices are acknowledged to be the tip of the iceberg since surgeons frequently do not do these online reports.

What Causes Breast Implant Illness

Researchers dont know why some women with breast implants develop BII. A leading theory, according to experts, is that some people are predisposed to having an immune reaction to the materials that are used to construct breast implants, creating inflammation that leads to symptoms such as joint and muscle pain, rashes, and gastrointestinal problems.

Studies have shown that substances from breast implants can bleed through an intact shell and into the surrounding tissue. Substances from an implant can also spread within the capsule of scar tissue surrounding the implant or to other parts of the body, often because an implant has ruptured. The longer a breast implant is in place, the more likely it is to rupture. Some, but not all, people with BII turn out to have a ruptured implant.

All women with breast implants are exposed to silicone to some degree, because all implants have a silicone shell.

It may be that the immune system is reacting to the silicone polymers that have been dispersed from the implant into the body, says Lu-Jean Feng, MD, a plastic surgeon and the founder and medical director of the Lu-Jean Feng Clinic in Pepper Pike, Ohio, who has been treating patients with BII since the early 1990s. Certain people may be genetically predisposed to be more reactive.

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Do Breast Implant Cause Cancer

The constructive and augmented breast implants are in use for almost 55 years. According to the FDA, elective breast augmentation is one of the most common plastic surgery. However, the studies have proved that breast cancer risk is not higher among women who have breast implants than those who dont. However, in 2009 the medical authorities noticed a rare type of cancer called anaplastic large-cell lymphoma occurred in the patients with breast implants but with minimal risk. Furthermore, In 2017, the American Food and Drug Administration released a report stating a slight but increased association between anaplastic large-cell lymphoma and breast implants. The FDA experts noticed several cases of this type of lymphoma since 2011. By 2017, the FDA identified 495 cases and nine deaths associated with ALCL. Each year more than 300,000 implant surgeries occur in America, making the risk very minimal about 1 in 3800 at the most and 1 in 30,000 at the least. Most of the patients who developed lymphoma had a gummy bear or textured implants . The treatment involves the removal of the implant and rarely require chemotherapy or radiotherapy.

Have You Developed Symptoms

Do Breast Implants Really Cause Cancer? Plastic Surgery Hot Topics with Rod J. Rohrich, MD

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.

  • Schedule a follow-up appointment with your treating physician to discuss and concerns you may have about your breast health.
  • Following a physical examination, patients with BIA-ALCL symptoms may receive an ultrasound or a magnetic resonance imaging of the symptomatic breast to evaluate for fluid or lumps around the implant and in the lymph nodes.
  • If fluid or a mass is found, patients will require a needle biopsy with drainage of the fluid to test for BIA-ALCL. This fluid will be tested for CD30 immune staining performed by a pathologist. Testing for CD30IHC is required to confirm a diagnosis or rule out BIA-ALCL. Fluid collections ruled out by CD30IHC for BIA-ALCL will be treated as typical seromas by a physician. Specimens not testing for CD30 may miss the diagnosis of BIA-ALCL.
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    Only Allergan Implants Are Being Recalled

    Many companies make textured breast implants, but only those manufactured by Allergan are being recalled. The Allergan Natrelle implants, which use a technology called BIOCELL, have been linked to a majority of BIA-ALCL cases. Allergan has recalled both saline and silicone-filled Natrelle textured breast implants, along with textured tissue expanders . You can view a complete list of the devices and lot numbers subject to the recall at the FDA website.

    Do Breast Implants Really Cause Cancer

    Dr. William A. Stefani, F.A.C.S., cosmetic and reconstructive plastic surgeon, provides expert opinion on breast implants, their relation to ALCL and what the medical community is doing to protect and inform the public.

    We have known about a very rare form of cancer associated with breast implants called anaplastic large cell lymphoma or ALCL since 1990 when it was first reported says Dr. Stefani. The risk of developing ALCL is about 300 in 10,000,000, so the rate is extremely low and its generally treatable. Breast implant use is tremendously popular for breast augmentation as well as reconstruction. In 2016, augmentation solely accounted for nearly 200,000 cases in the United States and reconstruction added another 100,000.

    Since the 1990s, approximately 350 cases of ALCL have been associated with breast implants. Unfortunately, the exact number of cases is unclear due to noncompliance and reporting limitations but we do know that of the reported cases, only 231 have information of the implants surface texture.

    One of the predictive signs of ALCL is sudden swelling from fluid around the implant. This symptom typically has a better outcome than a firm mass on the capsule, with zero deaths reported, if the implant and capsule are removed.

    For more information on Spa Renaissance & Renaissance Plastic Surgery please visit www.renaissanceps.com or contact Dr. Stefani and Dr. Williams.

    Have a question? Wed love to hear from you.

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    Number Of Cases Of Breast Implant Illness

    To date, there havent been any studies that looked at the number of women with breast implants who develop BII. More women have been reporting BII symptoms to doctors and to the FDA during the last few years, which may be because social media groups and media coverage helped to raise awareness of the condition. Thousands of women have joined online communities related to breast implant illness. For example, the Breast Implant Illness and Healing by Nicole Facebook group currently has more than 100,000 members.

    Currently, there are no commonly used diagnostic tests or diagnostic criteria specifically for BII.

    Plastic surgeons who have treated a lot of patients with BII say that its common for those who seek treatment to have multiple symptoms that are interfering with their ability to function. Many have gone to a number of other doctors before realizing that their symptoms may be connected to their implants.

    Usually, my clients with BII find me after exhausting all other medical avenues and going through exhaustive medical testing, says Robert Whitfield, MD, FACS, a plastic surgeon in Austin, TX, who treats patients with BII and is the 2019 president of the Aesthetic Surgery Education and Research Foundation.

    Questions About The Materials In Implants

    Breast Implant

    A key question that needs further investigation is whether some people may be predisposed to having a reaction to the materials in breast implants, causing inflammation and autoimmune problems. While the exact cause of BII and BIA-ALCL isnt known, some researchers have theorized that an inflammatory reaction could play a role in both conditions.

    Its clear that women whove had breast implants with a textured surface have a greater risk of developing BIA-ALCL compared to women who have only ever had implants with a smooth surface. But researchers dont know why. Some have theorized that the rough surface of textured implants might cause chronic inflammation that can lead to lymphoma. Others have proposed that the rough surface and greater surface area traps more bacteria, creating a biofilm that causes inflammation and leads to lymphoma.

    Some doctors consider saline-filled implants to be a safer choice for women who are concerned about the potential health risks of breast implants. If a saline-filled implant ruptures or its valve fails, its fairly easy to detect the leak because the breast will quickly appear deflated. Also, the saline that leaks out will be absorbed by the body.

    However, it’s important to know that all women with breast implants are exposed to silicone to some degree, because both silicone and saline implants have a silicone shell.

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    Emerging Risks Of Breast Implants

    Doctors often present breast reconstruction surgery as an important step that can help women move forward and feel more comfortable with their appearance after a mastectomy. And for many, it does more than 60% of women choose to have some kind of reconstruction after mastectomy, and most report they are satisfied with the results. 1

    Like any surgery, breast reconstruction procedures carry risks, and reconstruction with implants the most common type of breast reconstruction carries risks that some women whove undergone the procedure say they werent adequately warned about.

    The FDA has long advised women considering breast implants that they shouldnt expect them to last a lifetime, and should assume theyll need additional surgeries at some point because of well-known complications like capsular contracture and implant rupture. But there are also two serious risks that recently started to receive more attention from health authorities, doctors, and the media because of new research and because women who were affected are speaking out.

    Implants Linked To A Type Of Lymphoma

    The FDA first reported a possible link between breast implants and anaplastic large cell lymphoma in 2011. Evidence showed this rare type of lymphoma occurs more often in women who have implants with textured surfaces compared with smooth surfaces.

    Since then, more evidence has strengthened the FDAs understanding of this link. In announcing the recall, the FDA stated that the overall incidence of BIA-ALCL appears to be low, but the risk is greater than previously thought. The risk appears to be more closely linked with Allergan BioCell implants than with other types of textured implants.

    • 573 cases of BIA-ALCL and 33 deaths have been reported around the world, up from 457 cases and 9 deaths in February 2019.
    • Of the 573 cases of BIA-ALCL, 481 have been attributed to Allergan implants.
    • Of the 33 deaths, 12 patients had an Allergan breast implant at the time of their BIA-ALCL diagnosis, and one was from another company. The manufacturer of the other 20 patients implants is not known.

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