PEOPLE.COM HEALTH FDA Warns Breast Implants Increase the Risk of a Rare Type of Lymphoma The FDA has warned that implants are connected to a rare type of lymphoma By Maura Hohman February 08, 2019 05:28 PM As the Food and Drug Administration prepares to meet in March to discuss the safety of breast implants, the FDA is warning there may be an association between implants and a rare type of cancer. Of 457 confirmed cases of the condition caused by implants — called Breast Implant Associated-Anaplastic Large Cell Lymphoma or BIA- ALCL — nine patients have died. Based on existing research, the FDA says the frequency of the disease ranges anywhere from 1 in 3,000 women with implants to 1 in 30,000. Some 1.5 million women get breast implants every year. A letter addressed to health care providers on Wednesday states: “The FDA received reports indicating that patients with breast implants have an increased risk of developing this disease within the scar capsule adjacent to the implant.” The FDA goes on to explain that BIA-ALCL “is not a cancer of the breast tissue” and to ask doctors to be more cautious with patients experiencing “new swelling, lumps, or pain around breast implants.” RELATED: Former Playboy Models Get Their Breast Implants Removed Believing They Caused Illness Implants can come with smooth or textured exteriors and saline or silicone gel interiors, and the letter also explains that most cases of the disease have occurred in patients with textured implants. But it’s been found with smooth implants as well. Most of the women diagnosed with BIA-ALCL visited their doctors because of “pain, lumps, swelling, or asymmetry” that developed after they were fully healed. Europe has already taken steps to ban textured implants because of their association with BIA-ALCL, says Dr. Marguerite Barnett, one of the nation’s top surgeons for removing implants or “explanting.” “Initially, [BIA-ALCL] was said to be very rare, but as time goes by, they’re finding more and more cases,” Barnett explains to PEOPLE. “It’s a serious tumor capable of killing people.” While Barnett hasn’t personally dealt with any cases of BIA-ALCL in her patients, a more frequent issue she’s seen is what’s referred to as Breast Implant Illness or BII. There’s no official diagnosis, though, because, Barnett says, “95 percent of plastic surgeons don’t think it exists.” “It takes a while for symptoms to emerge, so most doctors don’t put two and two together,” she says. “I’ve been a little bit upset because some of my colleagues are saying it’s not a real thing.” The condition, in Barnett’s experience, looks like chronic fatigue, aches and trouble breathing, and there’s very little research into what about the implants may cause it. She says patients will come to her with such symptoms, often having read about BII on social media, and 60 percent of patients with saline and two thirds of patients with gel will feel better after getting them removed. While some of her colleagues, she says, have challenged her findings with accusations that it’s a placebo effect — which she concedes is “real” — she doesn’t believe it’s the case for her patients. “Usually about one-third of people feel better with placebos and it happens right away, but the effects fade over time,” she explains. “With my patients, it’s the opposite. About two-thirds feel better after at least a year, and they improve as time passes.” RELATED: Crystal Hefner Removes Her Breast Implants Because They ‘Slowly Poisoned Me’ In Wednesday’s letter, the FDA also urged surgeons who provide breast implants to provide their patients with the manufacturer’s labeling and educational material — and to have a discussion about the “benefits and risks” of implants. It’s exactly what Sia Cooper — who runs the popular blog Diary of a Fit Mommy and who openly suffered from what she believes is Breast Implant Illness — has been advocating for. She got her implants — smooth with gel — in 2011 and out in early December, Cooper tells PEOPLE. When she chose to have the surgery, she says her doctor told her nothing about the risks of implants beyond “capsular contracture” — which refers to the forming and tightening of scar tissue around the implants that happens to most women — and “infection with surgery.” After about a year, she started to “feel differently … My hair was falling out, and my weight was slowly climbing,” she recalls to PEOPLE. “I was inflamed. I felt like my body was attacking itself.” RELATED VIDEO: Chelsea Handler Slams Breast Implant Rumors Adding that there were days she couldn’t get out of bed, Cooper continues: “The illness hit me like a ton of bricks [last] year. I look back, and it was silently creeping up on me … I thought it was part of motherhood and getting older, but I’m like, ‘I’m 29. I shouldn’t be feeling like this.’ “ Some two months after her surgery, Cooper is feeling better. It’s unclear exactly what percentage of women with implants develop symptoms of BII, in part because there’s no registry for those who have them, Barnett says. She adds that this dearth in information is shocking because a registry is standard procedure for many devices implanted in the body, such as pacemakers. But, Barnett emphasizes that shouldn’t diminish the importance of tracking BII. “I believe these women,” she asserts. “It makes sense that if you put some foreign body in it that you’re going to have a reaction.” @mkhh09 SHOP | PEOPLE.com may receive compensation when you click through and purchase from links contained on this website. Magazines & More Learn More Subscribe Advertise Sitemap Student Offer Connect Follow Us Subscribe to Our Newsletter OTHER MEREDITH SITES © Copyright 2019 Meredith Corporation. People is a registered trademark of Meredith Corporation All Rights Reserved. People may receive compensation for some links to products and services on this website. 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PEOPLE .COM HEALTH
FDA Warns Breast ImplantsIncrease the Risk of a RareType of LymphomaThe FDA has warned that implants are connected to a rare type oflymphoma
By Maura Hohman February 08, 2019 05:28 PM
As the Food and Drug Administration prepares to meet in March todiscuss the safety of breast implants, the FDA is warning there maybe an association between implants and a rare type of cancer.
Of 457 confirmed cases of the condition caused by implants — calledBreast Implant Associated-Anaplastic Large Cell Lymphoma or BIA-ALCL — nine patients have died. Based on existing research, the FDAsays the frequency of the disease ranges anywhere from 1 in 3,000women with implants to 1 in 30,000. Some 1.5 million women getbreast implants every year.
A letter addressed to health care providers on Wednesdaystates: “The FDA received reports indicating that patients with breastimplants have an increased risk of developing this disease within thescar capsule adjacent to the implant.”
The FDA goes on to explain that BIA-ALCL “is not a cancer of thebreast tissue” and to ask doctors to be more cautious with patientsexperiencing “new swelling, lumps, or pain around breast implants.”
RELATED: Former Playboy Models Get Their Breast ImplantsRemoved Believing They Caused Illness
Implants can come with smooth or textured exteriors and saline orsilicone gel interiors, and the letter also explains that most cases ofthe disease have occurred in patients with textured implants. But it’sbeen found with smooth implants as well. Most of the womendiagnosed with BIA-ALCL visited their doctors because of “pain,lumps, swelling, or asymmetry” that developed after they were fullyhealed.
Europe has already taken steps to ban textured implants because oftheir association with BIA-ALCL, says Dr. Marguerite Barnett, one ofthe nation’s top surgeons for removing implants or “explanting.”
“Initially, [BIA-ALCL] was said to be very rare, but as time goes by,they’re finding more and more cases,” Barnett explains to PEOPLE.“It’s a serious tumor capable of killing people.”
While Barnett hasn’t personally dealt with any cases of BIA-ALCL inher patients, a more frequent issue she’s seen is what’s referred to asBreast Implant Illness or BII. There’s no official diagnosis, though,because, Barnett says, “95 percent of plastic surgeons don’t think itexists.”
“It takes a while for symptoms to emerge, so most doctors don’t puttwo and two together,” she says. “I’ve been a little bit upset becausesome of my colleagues are saying it’s not a real thing.”
The condition, in Barnett’s experience, looks like chronic fatigue,aches and trouble breathing, and there’s very little research intowhat about the implants may cause it.
She says patients will come to her with such symptoms, often havingread about BII on social media, and 60 percent of patients withsaline and two thirds of patients with gel will feel better after gettingthem removed.
While some of her colleagues, she says, have challenged her findingswith accusations that it’s a placebo effect — which she concedes is“real” — she doesn’t believe it’s the case for her patients.
“Usually about one-third of people feel better with placebos and ithappens right away, but the effects fade over time,” she explains.“With my patients, it’s the opposite. About two-thirds feel betterafter at least a year, and they improve as time passes.”
RELATED: Crystal Hefner Removes Her Breast Implants BecauseThey ‘Slowly Poisoned Me’
In Wednesday’s letter, the FDA also urged surgeons who providebreast implants to provide their patients with the manufacturer’slabeling and educational material — and to have a discussion aboutthe “benefits and risks” of implants.
It’s exactly what Sia Cooper — who runs the popular blog Diary of aFit Mommy and who openly suffered from what she believes is BreastImplant Illness — has been advocating for. She got her implants —smooth with gel — in 2011 and out in early December, Cooper tellsPEOPLE.
When she chose to have the surgery, she says her doctor told hernothing about the risks of implants beyond “capsular contracture” —which refers to the forming and tightening of scar tissue around theimplants that happens to most women — and “infection withsurgery.”
After about a year, she started to “feel differently … My hair wasfalling out, and my weight was slowly climbing,” she recalls toPEOPLE. “I was inflamed. I felt like my body was attacking itself.”
RELATED VIDEO: Chelsea Handler Slams Breast Implant Rumors
Adding that there were days she couldn’t get out of bed, Coopercontinues: “The illness hit me like a ton of bricks [last] year. I lookback, and it was silently creeping up on me … I thought it was part ofmotherhood and getting older, but I’m like, ‘I’m 29. I shouldn’t befeeling like this.’ “
Some two months after her surgery, Cooper is feeling better.
It’s unclear exactly what percentage of women with implants developsymptoms of BII, in part because there’s no registry for those whohave them, Barnett says. She adds that this dearth in information isshocking because a registry is standard procedure for many devicesimplanted in the body, such as pacemakers.
But, Barnett emphasizes that shouldn’t diminish the importance oftracking BII.
“I believe these women,” she asserts. “It makes sense that if you putsome foreign body in it that you’re going to have a reaction.”
@mkhh09
SHOP |
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