# Fda Reports 457 Cases Of Rare Cancer Linked To Breast Implants



## 1QTPie (Feb 7, 2019)

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.

Women with breast implants have an increased risk of developing anaplastic large cell lymphoma, the FDA has said, compared to women who don't have breast implants.*

"We hope that this information prompts providers and patients to have important, informed conversations about breast implants," the federal agency said.

The FDA also issued a letter warning those in the medical field of the association between breast implants and anaplastic large cell lymphoma.

"We want all healthcare providers to be aware ... particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy," the letter said.

"We are also asking health care providers to report to the FDA cases of Breast Implant Associated - Anaplastic Large Cell Lymphoma. (BIA-ALCL) in patients with breast implants. This includes reporting individual cases as well as rates you may have experienced during your practice."

Most of the cancer cases occurred in people who had textured surfaces on their implants, rather than smooth surfaces. The illness is slow-growing and treatable when it's detected early.

*"When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle," the letter said.

"Over time, a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. In patients with breast implants, reported cases of BIA-ALCL were generally found adjacent to the implant itself and contained within the fibrous capsule."*

About 10 million to 11 million women in the world have breast implants, according to the American Society of Plastic Surgeons and the Plastic Surgeon Foundation.

The FDA first raised the possibility of the illness in 2011, saying there was a small but significant risk of developing the cancer after getting breast implants. It asked doctors whether they'd noticed changes in their patients and urged* women to check for symptoms such as fluid buildup or a mass around their implants. Symptoms of the cancer also include swelling and redness around the breast implants.*

Since that report, the scientific community has learned more about the link between breast implants and anaplastic large cell lymphoma.

People who are considering getting the surgery should do their research and discuss with their surgeons the risks and benefits of textured- and smooth-surfaced implants, the FDA has warned in the past.

*It said those who have breast implants should monitor them for any changes and get routine screenings such as mammograms or MRIs.*

https://edition.cnn.com/2019/02/07/health/fda-lymphoma-linked-to-breast-implants/index.html


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## HappilyLiberal (Feb 7, 2019)

The breasts are right by the lymph nodes.  Once cancer spreads to too many lymph nodes it's a wrap because those things spread the cancer throughout your body.  When I was diagnosed the cancer had only spread to two lymph nodes.  When he removed the mass, the surgeon also removed those two lymph nodes and ten additional lymph nodes surrounding those two to make sure he got all of the cancer.


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## RoundEyedGirl504 (Feb 7, 2019)

This is scary.


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## Leeda.the.Paladin (Feb 7, 2019)

I was just about to post this. Very scary!


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## Transformer (Feb 8, 2019)

Although I miss perky breast, I’m glad I had my implants removed.


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## Black Ambrosia (Feb 8, 2019)

I don’t know enough about implants. What’s the benefit of the textured surface? Do they feel different when you touch them? Are they supposed to be more resilient?


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## Everything Zen (Feb 10, 2019)

But is anyone really surprised?


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## Black Ambrosia (Feb 10, 2019)

Everything Zen said:


> But is anyone really surprised?


Yes and no. Cancer seems to be ubiquitous so its not surprising in that sense but breast implants are so common its surprising this didn't come out 20+ years ago unless the textured surfaces (the implied cause) are relatively new.


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## Everything Zen (Feb 10, 2019)

It’s seems apparent to me that the textured surface is being seen as an irritant to the body which is causing some form of inflammatory reaction leading to a gene expression signaling pathway causing this rare form of cancer.


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## Gin&Tonic (Feb 10, 2019)

I know someone who had to have her implant removed due to Brest implant illness. Luckily there was no cancer.


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## Transformer (Feb 10, 2019)

Black Ambrosia said:


> I don’t know enough about implants. What’s the benefit of the textured surface? Do they feel different when you touch them? Are they supposed to be more resilient?



Supposedly prevents encapsulation.


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## aminata (Feb 10, 2019)

It seems every 30 years or so there is a major backlash of some sort.  Wasnt in the 1980s there was an instance of women removing implants do to illness.  I think saline implants became popular then.


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## 1QTPie (Mar 20, 2019)

Days before a hearing on breast implant safety, US regulators have sent warning letters to two of the top implant manufacturers involved.  In the letters, the US Food and Drug Administration reprimanded Mentor and Sientra for historically failing to complete the safety studies required for medical devices to stay on the market.

If the firms do not have completed data within 15 days, the FDA warned, their blockbuster silicone implants could be pulled from the market.  The warning is a gesture to patients that the FDA intends to be firm with breast implant manufacturers, whose products have stayed on the market for years without adequate safety data, despite ranking in the highest-risk bracket for medical devices.

It comes amid global concerns over the safety of silicone breast implants, which have been officially linked to cancer of the immune system, and are alleged to cause autoimmune disorders.  

The US banned silicone implants in 1992, after 10 years of pushing industry for safety data to no avail.  But companies immediately mounted plans to get the incredibly lucrative product back into the most lucrative market.

Conferring with the FDA, they were able to keep administering the products to women in the US for the purpose of research.  The firms presented their data in 2004, but the FDA rejected their application as poor in quality. Seventy-five percent of women dropped out of the Mentor trial before their first follow-up.

In 2006, firms submitted three years of data - far less than the 10 years required - and the FDA conceded, on the grounds that companies engage in rigorous 10-year studies including at least 40,000 women.  Specifically, the FDA wanted to know the risks of rupture, leaks, scars contracting, difficulties performing mammograms around implants, links to lupus, and links to cancer.  To this date, nobody has seen complete data from those studies the firms promised to complete.

Until 2011, these gaps in data were dismissed as a work in progress.

But then the FDA, alongside regulators around the world, published a statement saying there is strong evidence silicone breast implants are linked to BIA-ALCL, a rare cancer of the immune system.  Since, thousands of women have reported autoimmune reactions, ruptures, scars contracting, and cancer.

Earlier this year, the FDA published data showing nine women have died and 457 have contracted BIA-ALCL related to breast implants.  The hearing on Monday and Tuesday is a bid to interrogate all of the major players in the market, amid pressure from researchers, patient groups, and other regulators around the world (France, for example, has banned Allergan's silicone implants).

The letters sent out to Mentor and Sientra focused on two products in particular.  The Mentor implant is called MemoryShape, approved in 2013.  On approval, Mentor agreed to conduct a specifically designed post-approval study.

The FDA cites 'several serious deficiencies in the manufacturer’s post-approval study', including low numbers of patients involved, a poor follow-up rate, and data inconsistencies, particularly failure to account for racial and ethnic disparities.

Sientra's Silicone Gel Implants, also approved in 2013 with an order to study them after, followed a similar fate.  The FDA slammed the poor follow-up rate of just 61 percent, and accused Sientra of doing little to improve that.


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## Maracujá (Mar 20, 2019)

Everything Zen said:


> But is anyone really surprised?



No ma'am.


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## momi (Mar 25, 2019)

Wow - I wonder if a lift can produce similar results?  I need to take care of some things.


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## intellectualuva (Mar 25, 2019)

Interesting. I wonder what is the protocol if they are pulled from the shelf and people still have them. Can insurance companies disqualify you from certain insurance coverage because you have/had them and/or didnt remove them.


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