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Breast Implants Tied to Cancer

Breast Implants and Cancer – What They Knew, When They Knew It

One of the main protocols for surgery is that the doctor will explain the risks of anesthesia, how the procedure will be performed and ways to promote healing, but often overlooked is educating the patient of the potential adverse effects that can result from a defective medical implant. If you or a loved one have breast implants, you should be aware of the increased potential for developing breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.

What They Knew

A recent study published in the journal JAMA Oncology supports the belief that cancer has a definite link to breast implants. Anaplastic large cell lymphoma (ALCL), a type of non-Hodgkin lymphoma, has been found in approximately one in 7,000 women who have implants. Scientists believe that the implants or bacteria on the implants may trigger an inflammatory response that over time could be linked to cancer. Most of the cases of ALCL have been reported in women who had textured, not smooth implants.

So far, there have been 359 reports of implant-associated lymphoma from around the world and nine women have died. While these numbers may seem low, this report has just been published and most doctors and patients haven’t been made aware of the signs and symptoms of this potential disease. These numbers may also appear to be sparse because the average diagnosis appeared 13 years after the initial implant surgery which caused doctors to at first question if the implants caused the cancer. However, the JAMA study states that women with ALCL were about 421 times more likely to have breast implants.

When They Knew It

While this JAMA study may be new, the first cases of ALCL and breast implants were reported way back in 1997. The FDA also issued a report in 2011 which said that breast implants were associated with an increased risk of non-anaplastic large cell lymphoma and that, “the FDA is aware of approximately 60 case reports of ALCL in women with breast implants.”

If the FDA knew for several decades that there was a risk for women who had breast implants to develop cancer, why weren’t these women informed? They should have been made aware of the danger and should have been educated on what signs to look for to ensure early detection (such as pain, swelling, or redness).

What Can You Do?

If you or a loved one was diagnosed with breast cancer after having breast implant surgery, you may be eligible to make a claim. You should have been informed of the risk for breast cancer and the possible threat to your health. If you had breast cancer surgery, you most likely have expensive medical bills to pay for or you lost wages when you had to take time off of work to recover. You deserve financial compensation to since you weren’t made aware of the potential for future complications. Contact us today to determine if you can make a claim.

Breast Implant Warnings In The News

BREAKING (8/5/19): Allergan Recalls Textured Breast Implants

On July 24, 2019, the FDA announced that they requested that Allergen pull from the market their textured breast implants due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). If you or a loved one has breast implants, here’s what you need to know.

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BREAKING (8/5/19): Recalled Allergen Breast Implants: There’s More to the Story That You Need to Know

We hear about recalls all the time on the news and usually, the problem requires an easy fix: your car needs a new part, you take it to the dealership. Your chair has a poorly constructed mechanism, you fill out a form and send it to the manufacturer for a refund. Your lettuce is contaminated with e.coli, so you return it to the grocery store and pick up a bag of Oreos instead. Simple enough, right? But what if you have a medical device that has been recalled? You can’t just make a short visit to your doctor’s office to remove it and it’s really scary to keep it in your body. It seems like enough studies and quality assurance tests should have been conducted to keep patients safe, right?

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BREAKING (7/29/19): Local impact of the Allergan BIOCELL breast implants recall

The U.S. Food and Drug Administration recently recalled a type of breast implant that has been linked with a rare type of cancer.

The FDA says out of 573 cases of this type of cancer worldwide, 481 occurred in women who have had Allergan’s BIOCELL textured implants, including 33 patient deaths. This type of cancer is not breast cancer but a cancer of the immune system called the anaplastic large cell lymphoma found in the scar tissue and fluid near the implant.
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BREAKING (7/24/19): Breast implants tied to rare form of cancer recalled at FDA request

Breast implant maker Allergan Inc. issued a worldwide recall Wednesday for textured models because of a link to a rare form of cancer. The U.S. Food and Drug Administration (FDA) said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface account for a disproportionate share of rare lymphoma cases. The move follows similar action in France, Australia and Canada.

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5/29/19: Allergan to recall textured breast implants in Canada

Allergan Plc said on Tuesday it will voluntarily recall and stop the sale of its Biocell textured breast implants in Canada after the country’s health agency suspended the company’s licenses for the implants, citing increased risk of cancer.

The Botox-maker in December took its textured breast implants off the market in Europe after a French regulatory body ordered a recall.

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5/5/19: FDA to end program that hid millions of reports on faulty medical devices

The Food and Drug Administration announced it is shutting down its controversial “alternative summary reporting” program and ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public.

The agency said it will open past records to the public within weeks.

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2/7/19: FDA reports additional cases of cancer linked to breast implants

A deadly cancer linked to breast implants has been found in additional women in the United States, federal health officials said.

At least 457 women in the United States have so far been diagnosed with anaplastic large cell lymphoma, the Food and Drug Administration said in a statement Wednesday. Of those, nine have died as a result of the rare cancer, which affects cells in the immune system and can be found around the breast implant.

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1/5/18: Breast Implants Linked to a Rare Cancer: How Big Is the Risk?

Women with breast implants are at increased risk of developing a rare type of cancer of the immune system, but the overall chance of getting this cancer from implants is very low, according to a new study from the Netherlands.

The study provides one of the most precise estimates to date of the risk for women with breast implants of developing this cancer, which is called anaplastic large cell lymphoma (ALCL), the researchers said. ALCL is not breast cancer; rather, it is a type of lymphoma, which is a cancer of the immune system cells. When it occurs in women with breast implants, the cancer typically appears in the scar tissue around the implant.

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1/4/18: Breast Implants Increase Cancer Risk, Large Lymphoma Study Shows

Breast implants are associated with an increased risk of a rare form of cancer, according to a new study published Thursday in JAMA Oncology. Although the issue has been known about for two decades, this is the largest study of the association between breast implants and lymphoma to date.

Scientists still sure how breast implants might be increasing a person’s risk of cancer. As the paper describes, the implant may trigger an inflammatory response. Alternatively, a bacterial species could be hitching a ride on the implant’s surface. Some women may even be genetically predisposed to develop this kind of cancer after a breast implant.

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1/4/18: Rates of Rare, Breast Implant-related Cancer May Be Higher Than Reported

A new study published Thursday confirms what oncologists have noticed for some time: that breast implants are associated with a small increased risk of cancer.

Health Canada insists the risk is very small, and that only five cases have been confirmed in the last 10 years. But CTV News has learned there have actually been many more women affected — nearly two dozen and possibly more — and that doctors may be missing some of the signs.

The new study in the journal JAMA Oncology found that approximately one in 7,000 women who get breast implants will develop a rare form of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.

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3/21/17: FDA Updates Warning on Link Between Textured Breast Implants and Rare Cancer

On March 21, 2017, the U.S. Food and Drug Administration (FDA) updated its 2011 warning about a link between breast implants and a very rare form of cancer: anaplastic large-cell lymphoma. Because the cancer is linked to breast implants, the FDA calls the cancer breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).

According to the FDA, “All of the information to date suggests that women with breast implants have a very low but increased risk of developing anaplastic large-cell lymphoma compared to women who do not have breast implants.” The risk of BIA-ALCL is higher in women who have textured implants, which have a bumpy surface, as opposed to smooth implants, according to the FDA.

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GET YOUR FREE BREAST IMPLANT CASE REVIEW TODAY

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LATEST ARTICLES

No Testing, Fast Approval, Injured Patients: Is the FDA Finally Listening to Mesh Survivors?

Dr. Chris DeArmitt, who is a consultant to the top technology firms in America, told Sky News: “I see an absolute disregard for proper testing. Testing is way less than you would see on a vacuum cleaner or a washing machine. It’s shocking. I’ve never seen anything like it in my career.”

No Testing, Fast Approval, Injured Patients: Is the FDA Finally Listening to Mesh Survivors?

You might be wondering “Testing for what?” You would probably be shocked to find out that “more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to FDA clearance for distribution or sale,” shares Consumers Union project director Lisa McGiffert in an article from the Fowler Tribune.

This loophole in the FDA is called the 510(k) process and it has allowed millions of patients to be irreparably harmed – and even killed – by the very device that was intended to help them. Now after several decades of patient injuries, billions of dollars being fought over in court, and countless devices being pulled from market (too little, too late, we might add), the FDA is only now looking into changing this horrific flaw in their system.

What is the FDA’s 510(k) Process?

The FDA’s 510(k) process allows medical devices companies to quickly fast-track a product to market based on a pre-approved product. This idea came about decades ago with the purpose to promote innovation but has instead become a way for big companies to slip their products to market for high profits while avoiding expensive testing. This has caused several inexcusable problems to arise. Here’s one tragic example: 

Transvaginal Mesh

A medical device can be approved for market based on a previous model, even one that was recalled. This is what happened in the huge debacle involving vaginal mesh. Protegen was the first vaginal mesh product on the market, but was recalled due to patient harm. However, even after it was pulled, dozens of additional mesh devices were sold and implanted in patients based on this poor design. Currently, hundreds of thousands of women are suffering from mesh and many will have to live with chronic pain, the impossibility of holding down a job, and the inability to have sex with their partners for the rest of their lives. 

But this story includes many more products beyond vaginal mesh-like IVC filters to prevent blood clots, Essure female sterilization devices, hip replacement products, and countless others.  The New York Times reports that these fast-tracked devices have caused 80,000 deaths and more than two million injuries.

Change is in the Air 

Fortunately, with documentaries like The Bleeding Edge, social media groups criticizing the FDA’s process, and advocacy groups, the FDA is reevaluating how it approves devices for market. According to the JAMA (Journal of the American Medical Association) Network,

“For premarket review of 510(k) devices, on February 1, 2019, the FDA released a Final Guidance Document for the ‘Safety and Performance Based Pathway.’ This optional pathway consists of using criteria that involve conformance to FDA-recognized consensus standards, FDA guidance, and/or special controls. It enables 510(k) clearance for certain medical devices if the device meets these specific criteria, which should include safety and effectiveness (as opposed to the often ill-defined ‘substantial equivalence’ to predicate devices). The decision to use this new pathway is determined by manufacturers, although the FDA can disagree with this determination.”

While this is a step in the right direction by requiring device companies to prove safety and effectiveness, many think that these changes don’t go far enough towards protecting patient health. For instance, JAMA suggests that “legislation should mandate that 510(k) devices show improved safety and effectiveness compared with marketed devices for the same clinical purpose, using meaningful clinical criteria to gain clearance. Although these criteria will differ based on the intended use of the device, all criteria should be based on patient-oriented clinical outcomes.”

Additionally, once a product is approved for market, many times the post-market surveillance falls to the wayside. Medical devices should have a registry so that patients can know what devices are implanted in them, doctors can properly treat problems that may arise, and companies can monitor their products more effectively. Car parts are meticulously tracked, shouldn’t medical devices be all the more!?!

Too Little, Too Late

It’s great that the FDA is reviewing it’s 510(k) process that has been grossly overused and under monitored for decades, but what about those who have already been harmed by an agency that favored billion-dollar medical device companies over the health and wellness of patients?

One way that this FDA change was brought about was through the voices and bravery of those who were injured by these faulty medical devices. If you or a loved one had vaginal mesh and had corrective surgery, your voice needs to be heard. Please call Periscope Group today at (800) 511-3838. It’s time to hold medical device companies accountable for the unbearable pain they caused you. We want to hear your story and we want to help you if we can.

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Sources
“Vaginal mesh: Tests on plastic material ‘way less’ thorough than on washing machine”. Sky News. Accessed August 5, 2019. https://news.sky.com/story/vaginal-mesh-tests-on-plastic-material-way-less-thorough-than-on-washing-machine-11772530?fbclid=IwAR0ieT27Sh1V8q53Vt7y3BH2PK1M9akqoLCAFvnf1JskMeAOu10yvzgEi20
“Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices”. JAMA Network. Accessed August 5, 2019. https://jamanetwork.com/journals/jama/fullarticle/2744408?fbclid=IwAR04Fkrn-A1NbJDUkuOOOU-EhA55G5kkXUYJWGIb8y-MftOdFTQ0hrk_Bl0
“Medical Device Testing: Too Much, or Not Enough?” ADMET. Accessed August 5, 2019. https://www.admet.com/medical-device-testing-too-much-or-not-enough/

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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