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July 27, 2019 4:59 pm
(CNN)Textured breast implants made by Allergan were recalled globally this week after the US Food and Drug Administration reported an increased number of cancer cases and deaths linked to the products.
If you're one of the hundreds of thousands of people who have the textured implants, you might be concerned.
Here's what you should know.
What are textured breast implants?
Textured implants have a rough outer shell, with a surface that feels kind of like sandpaper. They're typically used for implants with a teardrop shape, which are fuller on the bottom and can look more like a natural breast. The texture is designed to help the implant stick to the surrounding soft tissue, making it less likely to move around and look distorted, Dr. Colleen McCarthy, a reconstructive surgeon at Memorial Sloan Kettering Cancer Center, wrote in an email to CNN.
As you might expect, smooth implants have a smooth outer surface. Though they tend to move around a lot more, that movement isn't a concern because they are symmetrically shaped and look the same despite their positioning.
Why are these breast implants being recalled?
Allergan's textured breast implants have been linked to an elevated risk of a cancer called breast implant-associated anaplastic large cell lymphoma, also known as BIA-ALCL. BIA-ALCL is a cancer of the immune system, not breast cancer.
The FDA said that the risk of BIA-ALCL with Allergan's Biocell textured implants is six times higher than with other textured implants, and added that continued distribution of Allergan's Biocell implants would likely cause "serious, adverse health consequences and potentially death from BIA-ALCL."
How many people are affected?
Textured implants aren't as common in the US as they are in other countries, according to the FDA. The agency says that textured implants make up about 10 percent of all implants in the US, with Allergan's textured implants accounting for less than five percent of that.
Still, hundreds of thousands of people are estimated to have the textured implants from Allergan, Dr. Binita Ashar, director of the office of surgical and infection control devices at the FDA, said at a press conference on Wednesday. She added that the FDA will get more information on those numbers in the coming weeks.
Which products are part of the worldwide recall?
These are the Allergan implants that have been recalled.
- Natrelle Saline-Filled breast implants: styles 163, 168, 363 and 468.
- Natrelle Silicone-Filled breast implants: styles 110, 115, 120, TRL, TRLP, TRM, TRF, TRX, TCL, TCLP, TCM, TCF, TCX, TSL, TSLP, TSM, TSF and TSX.
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants: styles 410FM, 410FF, 410MM, 410 MF, 410 FL, 410 ML, 410 LL, 410 LM, 410 LF, 410 FX, 410 MX, 410 LX.
These are the tissue expanders that have been recalled:
- Natrelle 133 Plus Tissue Expander.
- Natrelle 133 Tissue Expander with Suture Tabs.
If you're not sure about the manufacturer or model of your implants, ask your surgeon or get medical records from the place that performed your surgery.
I currently have one of the recalled implants. Should I get it removed?
For now, the FDA isn't recommending that patients with textured breast implants get them removed unless they're showing symptoms. Though the risk of developing cancer from Allergan's textured implants is higher than other implants, it's still pretty rare overall. The cancer is also considered easily treatable if it's detected in time.
"Most patients diagnosed with BIA-ALCL will be cured by removal of both breast implants along with the scar tissue, or capsule, surrounding each implant," McCarthy said. "A small minority of patients will also require chemotherapy and radiation."
Understandably though, an elevated risk of cancer can be scary for patients, regardless of how rare it is. The American Society of Plastic Surgeons recommends that patients who are still concerned have a conversation with their health care providers about the best course of action.
If I want to get my textured implants removed, do I have to pay out of pocket?
The American Society of Plastic Surgeons has advocated for insurance companies to cover the cost of breast implant removal and other treatments for patients diagnosed with BIA-ALCL, McCarthy said.
Some insurance companies will cover the removal and/or replacement. If you don't have symptoms of the cancer right now, it's best to contact your insurance provider to see what they'll pay for.
What symptoms should I be on the lookout for?
BIA-ALCL typically develops about seven to 10 years after the textured breast implants are put in, according to Alan Matarasso, president of the American Society of Plastic Surgeons.
Any abnormal swelling in one particular breast is a red flag. Patients should also be on the lookout for pain, rashes, itchiness, firmness, masses or changes in the size and shape of the breast.
McCarthy said it's important to note that these signs do not necessarily mean a person has BIA-ALCL. They can also be from a leaking implant or other causes of swelling. If you experience any of these symptoms, it's important to see your health care provider and get it checked out.
Weren't these implants banned in other countries?
Yes. In December 2018, Allergan halted sales of two types of textured breast implants in Europe after France refused to renew approval for them. Then in April of this year, France issued a sweeping ban on two types of textured breast implants across six manufacturers because of the link to a heightened risk of cancer.
Canada soon followed suit with a ban on Allergan's Biocell implants. And in July, Australian authorities proposed a ban on 25 models of textured breast implants.
Why weren't textured breast implants recalled in the US until now?
The FDA first identified a possible link between breast implants and lymphoma in 2011, but the agency says that at the time, it couldn't determine what factors increased the risk of cancer.
Though other countries took steps to ban the implants earlier this year, the FDA was slower in its decision. The agency said it based its decision on the results of a public hearing held in March, as well as new data reported to the FDA since then.
There have been 573 unique cases of BIA-ALCL, and 33 people have died from the cancer worldwide. Out of those 573 cases, 481 of them involved Allergan's Biocell implants, according to the FDA. The agency said it knew the manufacturer of the implant in 13 of the deaths -- Allergan was the manufacturer in 12 of those cases.
The manufacturer for the remaining 20 deaths is unknown.
It's important to note that so far, the FDA has only pushed for a recall of Allergan's textured breast implants -- other companies in the US still have textured implants on the market.
Topic starter
July 27, 2019 5:09 pm
It's a terrible thing to think what you have in your body is now very dangerous. I would remove them even though it was stated that the cancer is rare to develop. I think if deaths have been caused by Allergan's textured implants it is one to many!
The FDA needs to do some more investigating quickly of the other companies that are using these types of implants.
July 28, 2019 4:52 pm
It is ironic that the women most likely to use these implants have had mastectomies and survived a breast cancer diagnosis. I hope in the future it will become more acceptable for women who have had a double mastectomy to choose not to receive implants and focus instead on retaining the strength and function of the surrounding muscle and joints.
July 29, 2019 7:21 pm
I have a friend who had a double mastectomy and the process afterwards of reconstruction and getting the surrounding tissues ready for a breast implant was quite extensive and took a long time. But she went through it after surviving cancer to heal herself emotionally and physically. The scars were a terrible reminder of her ordeal, and all the reconstruction she went through made her feel whole again and put the cancer behind her. There are implants that have been around for a while, tested and proven safe, and fortunately she these and not the newer textured ones
July 30, 2019 12:02 pm
My mom has had issues with her implants where one breast was swollen and she went to the doctor. I'm not sure which type she had, but personally I don't think it's healthy either way.
July 31, 2019 12:41 pm
If they are having this reoccuring problem with a certain type of breast implant and even with a brand of that implant, I think if the FDA won't ban them there should at least be guidelines for surgeons to follow to inform their clients of higher risks for cancer, and what that means if they were to develop it (that it's not a breast cancer, it attacks your immune system, so just removing the breast implant might not solve it.) People thinking about getting these types of implants should be encouraged to do their own research, find out why certain countries have these banned and get multiple surgeons opinions before deciding what to get. Although, even with all the information about risks there are still women who will choose to get these given the choice to, and that just comes with personal decisions on what risks are worth the benefit, but if it was me I would have it removed anyways even if no symptoms were showing yet.
August 15, 2022 2:45 pm
I personally have always been interested in getting implants but after reading all the horror stories of ruptured and recalled implants I am rethinking them. It's horrifying to hear that these types of things aren't regulated better because they are going into bodies to give women a confidence booster.
August 15, 2022 2:47 pm
@mikaylaalleniectskin-com That's really scary! My friend hadn't even had her implants for a full year and one of them busted and they were recalled so she had to schedule another surgery to get different implants.
August 15, 2022 2:51 pm
I have always wanted impants to be honest and despite the horror stories i think id be willing to take the risk. There are hundreds of amazing surgeons out there you just have to remember you get what you pay for and you have to take the healing time seriously.
August 15, 2022 2:52 pm
@laurenjohnsoniectskin-com My friend just recently got hers done and they look so good , they havent "fluffed" yet but it comes with time.
August 15, 2022 2:59 pm
@abigailcochraneiectskin-com I agree if you do your research and find a board certified surgeon you have a better chance of finding someone who will do honest quality work. I would never go and get them done for a cheap price just because it's cheap!
August 16, 2022 12:32 pm
After care plays an important role in healing as you know from Masters Class. Pre and post op are the 2 concerns I have that many Doctor's do not do or advocate for
August 16, 2022 12:34 pm
Yes get several opinions and ask to see their work. There are doctor's that specialize in certain areas of the body.
August 16, 2022 12:35 pm
I've always been afraid of that happening but I do not think it happens as much as different materials are used for certain skin
August 16, 2022 6:01 pm
@deborahwatersiectskin-com I agree I think that checking the doctors portfolio, asking questions and seeing what their professional opinion is about what you should get done are all important steps. Certain doctors will not give a woman a certain size because they feel it won't look right and at the end of the day that's their name on your body!
August 23, 2022 4:19 pm
any type of plastic surgery scares me. there are so many risk that come with getting plastic surgery. breast implants are one of the more risky procedures. they could rupture, have constant breast pain, necrosis, etc.
This post was modified 2 years ago by Keyonna Starks
August 23, 2022 4:21 pm
@abigailcochraneiectskin-com i agree. there are a lot of great surgeons out there, you just have to be willing to do the research to find them.
August 26, 2022 4:58 am
I've always wanted breast implants, but at the same time the idea of a foreign object in my body kinda freaks me out. The thought of it rupturing, moving or possibly giving me cancer would constantly be on the back of my mind. I do wish there was a way to get larger breasts without implants. I've heard a fat transfer breast augmentation is possible, but I've never heard much about it in the media so I don't know much about the procedure, honestly.
August 26, 2022 5:07 am
@leejenkinsiectskin-com I'm really glad the implants worked out for your friend. Women who have survived cancer have already been through so much, it makes me really sad to think that on top of everything else, possible cancer caused by the implants is one more thing some of them may have to worry about.
August 26, 2022 5:12 am
@tabethapetersoniectskin-com I definitely agree with you, anyone making a decision this big should be fully informed of all the risks and dangers of the procedures. After they completely understand, it should be up to them whether or not it's a risk they're willing to take.
August 28, 2022 9:26 pm
Breast implants have always been a deep thought in the back of my mind. They scare me though. Something could always rupture or bring your harm.
August 28, 2022 9:30 pm
@lanajacksoniectskin-com It does scare me that they could possibly give you cancer.
August 28, 2022 9:32 pm
@lanajacksoniectskin-com It does scare me that they could possibly give you cancer.
August 28, 2022 9:34 pm
@lanajacksoniectskin-com It does scare me that they could possibly give you cancer.
August 28, 2022 9:42 pm
@keyonnastarksiectskin-com Plastic surgery isnt made for every body type. Sometimes the only way to find out if your body doesnt like it it just to get it done.
April 2, 2023 2:46 pm
I have thought about breast implants a couple of times but I know that it is not a safe idea. I hear some stories where they have no problems with their implants and I hear not good stories about getting implants.
April 2, 2023 2:49 pm
@abigailcochraneiectskin-com I agree there are amazing surgeons that probably have mastered breast implants. I think it is important to do a lot of research before getting them done.
April 2, 2023 2:51 pm
@cameranriddleiectskin-com I agree it does scare me a little. I wouldn't want any harm done to my body and the thought of them rupturing really scares me.
April 7, 2023 9:55 am
I know a few people that have gotten breast implants and love them. Any type of cosmetic surgery is risky I think. It is important to do research on the possible side effects, and the doctor you are going to see so you know you can trust your doctor with a smooth procedure.
April 7, 2023 9:57 am
@abigailcochraneiectskin-com pre and post op care is so important! If a person does not take the proper care it can lead to infection or other potential problems.
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