Tag Archives: Implants

Breast Augmentation and Plastic Surgery Are on the Rise – What Are the Risks?

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Juliana Guarracino, Honeysuckle Magazine: December 29, 2021

In the past year, the Brazilian butt lift (BBL) has swarmed many TikTok feeds with women sharing their experiences, both good and bad. From 2017 to 2019, the number of BBL procedures has increased by about 38 percent. This is despite a 1 in 20,117 patient mortality rate when performed by a board-certified plastic surgeon in the United States, which is higher than the death rate of outpatient surgery overall. This has accompanied an overall 33 percent increase in cosmetic surgery for women between 2000 and 2020. Though, with a growing number of patients, the safety measures meant to guarantee their safety are disputed among experts.

[….]

What Are the Risks of Breast Augmentation Surgery?

A lot of information on social media, according to Youn, tends to be advertisements, rather than credible material. There is little regulation, however, on who is able to perform plastic surgery in the United States. As Youn mentioned, not all doctors seem to put patient safety first. By law, any licensed doctor can perform plastic surgery regardless of their field and qualifications. Board certification is also not required for plastic surgeons. With such a lack of legal oversight, the idea behind this checklist is that it can help inch patients and surgeons closer to honest and informative conversations.

“With breast augmentation, it is very appealing that a patient may want it so badly, [overlooking] that there are potential downsides or risks or maintenance,” said Dr. Allison Lied, board-certified plastic surgeon and member of HealthyWomen’s Health Advisory Council. Recent regulations seek to provide patients with the information necessary to make an educated decision. Since cosmetic surgery is elective, it is especially important that there be informed consent as the procedure has the ability to put a healthy individual into a potentially life-threatening condition, according to both Lied and Youn. “I think [checklists are] good because it makes the patient slow down and consider those potentials.”

With these new mandates, surgeons must review the checklist with patients, and to confirm their understanding, patients must initial and sign the document. While this may be satisfactory enough to ensure that patients receive all information needed to guarantee their safety, Dr. Diana Zuckerman, president of the National Center for Health Research, is still concerned about the enforcement of the regulation.

“There is nothing to stop the surgeon… from saying ‘I have to give this [checklist] to you and you have to sign it, but honestly this is the safest procedure possible, and breast implants have been studied and you really don’t have to worry at all,’” Zuckerman said. While she is glad to see further regulation, she questions how the FDA will be able to ensure the thoroughness of the consultation and discussion of the checklist. “Are the women actually reading [the checklist]? Are they understanding it?”

Despite the checklist being comprehensive and informative, the design of the checklist may hinder a patient’s ability to understand the surgery and how a patient’s health may be affected, according to Zuckerman. “It starts with information you’ve already heard about… then, by the time they get to page four or five where the more important information is, are [patients] even going to be paying attention?”

The Best Breast Augmentation Information Versus FDA Hesitation

Before the release of the FDA’s most recent mandate, The Breast Implant Working Group, which includes Zuckerman along with surgeons, health policy experts and patients, spoke with the FDA to request a checklist that is more “user-friendly” than the one that the FDA had planned to release. Suggestions included clarifying potential risks, such as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system, and Breast Implant Illness (BII), which includes symptoms like memory loss, chronic fatigue and a low-grade fever. They also advised implementing a more comprehensive list of possible symptoms with stronger descriptions. The Working Group recommended that the FDA work with manufacturers to create a certification course for surgeons using their implants as well in order to address the issue of enforcement for the checklist. While these experts and advocates believed that these revisions would help to ensure informed consent for patients, the FDA proceeded with their own checklist, largely ignoring the recommendations made by the team.

[….]

While it is understandable that the FDA would be cautious about passing new regulations on something that is perhaps novel and under-researched, this is not the case for breast augmentation. With 193,073 individuals receiving breast augmentation surgery in 2020, the FDA’s hesitancy to recommendations and research may prove more dangerous than beneficial.

“No matter what’s in writing and what’s required, once you are in the doctor’s office and it’s just you and the doctor or you and the nurse, what is there to ensure you are getting accurate information?” said Zuckerman. Patients can do their own research on surgeons and procedures, but experts and policy makers in the field can further support their education and safety. For those women going under the knife and the experts supporting them, being listened to may be what defines the future of women’s health. “It’s one thing to have a good idea, another to implement this idea and another idea to enforce it.”

To read the entire article, click here.

My breast implants are making me sick — and I’m not alone

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Pamela Appea, Salon: June 20, 2021

In November 2016, a few weeks after I had breast implant surgery, I came down with an unexpected case of thrush (an unappealing fungal infection characterized by a thick white coating on my tongue). As a Black married mother of two, even though I was still sick, I tried — but failed — to power through and take care of my kids. With intense flu-like aches, pain, and fever, it hurt to eat, drink, swallow, or even open my mouth. I couldn’t properly brush my teeth for several days.

Unfortunately, my primary care physician was on vacation. Panicked, I called the Manhattan oncologist whom I had seen a few weeks earlier. He’d been very kind to me following my DCIS breast cancer diagnosis, unilateral mastectomy and post-surgical treatment. The officer’s medical team could barely understand me when I tried to make the appointment on the phone.

“I don’t think you have thrush — didn’t I just see you a few weeks ago?” he said, trying to put me at ease as I stared at his cheerful neon tie. (I think he prided himself on his fun ties.)

It was torture opening my mouth so the doctor could diagnose me.

“Okay, that’s the worst case of thrush I’ve seen in some time,” the seasoned specialist said. He said he was putting me on antibiotics stat. I asked — or rather, wrote on a notepad, since I couldn’t speak clearly — if there could be any connection between the my immune system and the very new breast implant that was now in my body. The oncologist emphatically dismissed the notion as impossible.

Once he got the results of my lab work back, my physician said there was no evidence of anything wrong; I should bounce back in a few days. “These things sometimes happen,” he told me, smiling as he ushered me out.

While the antibiotics eventually cleared up the thrush, unfortunately I have never fully bounced back. In subsequent years since my breast implants were put in, it became even more clear that something was going on with my immune system. But none of my doctors really listened.

Although it was not formerly recognized by the medical community until recently, Breast Implant Illness (BII) has, in the past few years, finally received attention from both media and researchers. Nicole Daruda founded a Facebook’s support group, called Breast Implant Illness Healing by Nicole, in 2013; now, it boasts over 145,000 members. Daruda tentatively estimates that 50,000 women in the US have BII, although precise research-backed numbers are not readily available

“We are overwhelmed by women trying to join the Facebook group to be educated about Breast Implant Illness,” Daruda said. She estimates that 3,000 to 5,000 women message the group’s moderators every month. To try to meet the demand, Daruda later founded a nonprofit, Healing Breast Implant Illness Society of North America.

Research is just barely starting to emerge on BII. One study, published in Annals of Plastic Surgery in 2020, followed 750 women suffering from Breast Implant Illness over a multi-year time period. Once these women surgically removed their breast implants, the vast majority reported the majority of their symptoms had significantly improved or disappeared entirely.

Awareness appears to be growing, too. A wave of celebrities are talking more openly about breast implants and their health and wellness — including Victoria Beckham, Ayesha Curry, Ashley Tisdale, Chrissy Teigen and others.

A documentary that touches on the subject of BII, “Explant,” is screening right now at the Tribeca Film Festival. The film follows Michelle Visage, one of the celebrity judges on “RuPaul’s Drag Race.” Visage, a media personality, singer, DJ and actor who was well known for her signature Double-D breasts, found that doctors didn’t take her seriously when she told the specialists her immune system was out of whack. Visage experienced chronic health issues, including Hashimoto’s disease, that she now attributes to her breast implants.

Awareness of BII is crucial given the popularity of breast implants. Since 1998, the number of breast augmentation procedures in the US has increased threefold; now, they are one of the most sought-out cosmetic procedures.

“The desire for breast augmentation seems so powerful regardless of what else is going on in the world,” said Dr. Diana Zuckerman, founder of the National Center for Health Research. “What most concerns me is how reluctant most plastic surgeons have been to make sure their patients know the risks before making a decision.”

Because breast implant technology has existed for decades, many women erroneously believe they are safe.

[….]

In the years after my implant, some of my symptoms mirrored women on support groups I found online, which is how I figured out I had Breast Implant Illness. While symptoms sometimes waxed and waned, I got used to experiencing a host of autoimmune and other symptoms like insomnia, brain fog, extreme breathlessness, cuts that took weeks to heal, rashes, frequent colds and much more.

But BII is no longer regarded as a myth. Many or even most doctors, including plastic surgeon Dr. Anthony Youn, believe Breast Implant Illness is real. Dr. Youn acknowledges it is a controversial topic among many of his fellow American plastic surgeons.

“If you’re happy with your breast implants and you don’t believe they are adversely affecting your health, then there is no need for treatment. If you are sick and believe your implants may be the cause, speak with your primary care physician and a board-certified plastic surgeon about whether explantation may be a possible solution for you,” Dr Youn said. “There are many causes of the symptoms of Breast Implant Illness (BII) that don’t involve breast implants, so it’s often best to rule those out first,” he continued.

In his 17 years of practice in the metro Detroit region, Dr. Youn, a member of the American Society of Plastic Surgeons and The Aesthetic Society, has performed surgery on thousands of women who elected to get breast implants. Anecdotally, he estimates the number patients who later returned to his practice stating they had Breast Implant Illness symptoms is an extremely small percentage.

[….]

Though not all women with breast implants go on to develop Breast Implant Illness, all women deserve education, informed consent, insurance coverage and most important information about potential risks. If, in 2015, there had been an FDA Breast Implant Black Box Warning (which was officially unveiled in late 2020), I honestly never would have gotten breast implants in the first place.

To read the entire article, click here.

‘They killed her’: Why are breast implants still putting millions of women at risk?

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Maria Aspan, Fortune: May 18, 2020

Thirty-three years before her death, Paulette Parr visited her doctor for a popular and relatively routine procedure. It was 1986, and Parr was 35, working in human resources at the local hospital in Sikeston, a 16,000-person Missouri enclave midway between St. Louis and Memphis. A married mother of two young boys, she was interested in what plastic surgeons still call a “mommy makeover,” a catchall for the various procedures that nip, tuck, and lift women back to a pre-childbirth shape. For Parr, that meant getting her first set of breast implants.

For the next 15 years, through losing her first husband and remarrying and getting promoted to her hospital’s purchasing department, Parr was mostly happy with her implants, and with how they made her look and feel. But they were silicone-based, a type the U.S. Food and Drug Administration banned in 1992 over concerns that they were causing autoimmune and safety problems, and Parr eventually started to worry about them. So by 2002, when she learned that one of her implants had ruptured and was leaking silicone into her body, Parr’s surgeon replaced them with saline-filled versions. Her new Biocell implants were covered in a roughly textured silicone shell, designed to reduce movement of the device.

That’s when Parr’s implant-related health problems really began, according to a lawsuit her husband has filed against pharmaceutical company Allergan, the maker of Biocell products and one of three major manufacturers of American breast implants. In 2010, after one of her saline implants started leaking, her plastic surgeon replaced them with yet another set of Biocell textured implants, this time filled with silicone, which the FDA had allowed back onto the market in 2006.

“They were gorgeous, and they were put in by a reputable doctor,” says Paulette’s widower, Calvin Parr, months after her death. “We never gave it a second thought.”

Breast implants have long been a punch line, mocked as frivolous markers of female vanity. But that dismissive attitude overlooks a business with a serious and sometimes deadly impact on the health of its overwhelmingly female customer base. More than 8 million American women have undergone breast-related plastic surgeries since 2000; in 2018 alone, more than 400,000 women chose one for either cosmetic or reconstructive reasons. Breast augmentation is the most popular cosmetic procedure tracked by the American Society of Plastic Surgeons.

Many women, especially those affected by breast cancer, say they are grateful to have implants as an option. “It’s a decision that’s personal,” says Lynn Jeffers, the society’s current president, a plastic surgeon, and a cancer survivor who’s getting post-mastectomy reconstruction. “With the data that I have now, I’m comfortable having implants.”

And pharmaceutical companies have been very comfortable selling them, despite a long history of government recalls and product-liability lawsuits. Allergan, which was acquired by AbbVie in May, sold $399.5 million worth of implants in 2017, before regulators around the globe started banning some of its products. Its main rival, Johnson & Johnson, doesn’t break out results for its Mentor Worldwide breast implant business. Smaller specialist Sientra reported annual “breast products” revenues of $46.4 million in 2019.

Those numbers pale in comparison to blockbusters like Allergan bestseller Botox, which raked in $3.8 billion last year. But like Botox, breast implants can have attractive recurring revenue built in for manufacturers and the doctors who use their products. Even under ideal circumstances, breast implants “are not lifetime devices,” the FDA warns, and will likely need to be replaced every 10 to 15 years, for a cost of up to $12,000 per cosmetic procedure.

Yet as doctors, patients, lawyers, and public health experts tell Fortune, breast implants have remained on the market despite decades of inadequate testing and study, recurrent safety concerns, and poor regulatory oversight. Those problems plague many medical devices, which range from machines used outside the body to artificial parts implanted within it. But breast implants are unique in their affiliation with female sexuality and physical appearance, their intersecting roles as elective beauty products and clinical tools that can help cancer survivors feel more like themselves—and the degree to which patients’ mounting concerns about them have been dismissed for decades. Now, that accumulated failure of oversight has created sweeping, sometimes tragic crises for potentially millions of women.

“There are a lot of women who are really suffering,” says Diana Zuckerman, president of the National Center for Health Research. “You have these products that are widely, widely sold, and every few years we learn something new about the problems they cause.”

Breast implant makers walk a particularly fine line when it comes to creating a product that is both safe and “realistic.” Today’s implants are either filled with saline (more likely to break) or silicone (more natural looking and feeling but plagued by a history of safety concerns). Their exteriors can be either smooth or made of a “textured” silicone shell. Smooth implants are more popular in the U.S., but surgeons working with mastectomy patients sometimes prefer textured versions, because the products’ rougher surface enables tissue to grow onto the implant more easily.

All of these variations are prone to malfunctions or side effects, which can include ruptured implants; a buildup of scar tissue that can cause pain and tissue hardening; a large collection of symptoms often known as “breast implant illness,” which can include joint pain, migraines, and chronic fatigue; and, increasingly, a sometimes fatal cancer of the immune system known as ­BIA-ALCL, for “breast implant–­associated anaplastic large cell lymphoma.”

“The breast implants that are on the market right now all have issues,” says Madris Tomes, a former FDA manager who tracks reported medical device failures at her Device Events firm. “I wouldn’t recommend them to anyone that I care about.”

The causes of the various problems with breast implants are still poorly understood, which public health experts blame on a lack of testing or objective, long-term studies that do not rely on manufacturer-provided data or funding. Device makers also have yet to fully report the data the FDA required as a condition of allowing silicone implants back on the market in 2006.

[…]

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Woman with Rare Cancer Linked to Breast Implants Seeks to Spread Awareness

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CBS News: July 13, 2017.

[…] The American Society of Plastic Surgeons says around 550,000 women last year received breast implants, but the FDA published a report this year linking a rare cancer to the implants.

So far, there have been 359 reported cases globally, including nine deaths.

The risk is low, but one in 30,000 women with implants could develop it, including one patient who says she is battling the disease and her insurance company, reports CBS News correspondent Anna Werner.

Kimra Rogers was shocked to find a tumor under her arm. […]

Then she learned it was cancer, possibly connected to the cosmetic breast implants she’d had put in 17 years ago. […]

It’s called breast implant-associated anaplastic large-cell lymphoma, a rare cancer the FDA says can develop following breast implants, something doctors at MD Anderson Cancer Center in Houston have been studying for five years.

“This is a type of lymphoma. It is not a breast cancer. It’s actually a cancer that develops in the scar tissue around a breast implant,” said Dr. Mark Clemens. […]

But insurance companies don’t always agree to pay. Rogers says her insurer, Blue Cross Blue Shield of Montana, denied payment for removal of her implants three times, telling her it was a contract exclusion because her implants were cosmetic. […]

But Dr. Clemens said, “We can’t wait months or years till an insurance company say, ‘okay, we’re gonna cover it.'” […]

But if you notice any changes in the implants or your breasts, such as swelling, head to your doctor’s office as soon as possible to have any problems checked out.

Read the original article here.

Janice Dickinson Regrets Getting Breast Implants, Believes It Affected Cancer Diagnosis

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Ali Venosa, Medical Daily: May 21, 2016.

Breast implants are one of the most popular cosmetic procedures on the planet, but that doesn’t mean they’re never regretted. Supermodel Janice Dickinson, 61, told Entertainment Tonight that when her doctor told her she had stage 1 breast cancer, she wished she never went under the knife.

The mammogram technician added it’s more difficult to detect abnormalities in the breasts when a woman has implants, to which Dickinson replied, “Take them out! Take them out, cut them out! Just take them out now!” Luckily, she doesn’t need to undergo a mastectomy, and instead will begin radiation treatments next week. If she had to do it all over again, Dickinson said she “would have never gotten breast implants in the first place. […]

Though breast implants do not appear to increase a woman’s risk of breast cancer, there may be a link between implants and an increased risk of anaplastic large cell lymphoma (ALCL). In 90 percent of breast cancer cases, women find a breast lump themselves and bring it to the attention of their doctor. With implants, it can be a little more difficult to recognize changes in the breasts. According to one study, 55 percent of breast tumors were missed in women with implants compared to 33 percent of tumors in women without them. […]

For women worried that a mammogram will damage their implants, Bevers said not to worry: The benefits of a mammogram far outweigh any small risk of implant damage. But if women do have them, they should tell their clinician so that it’s easier for them to spot any unusual changes that may be taking place. Regardless of implants, though, the best defense against breast cancer is to be familiar with your breasts and to attend screenings regularly.

Overall, Dickinson herself doesn’t plan on slowing down. It’s not a “big pity party,” she said. “I am living and I am happy.”

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FDA explores possible link between breast implants, cancer

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Andrew Zajac, The Los Angeles Times: January 26, 2011.

The Food and Drug Administration announced Wednesday that it has begun investigating the possible connection between breast implants and an increased risk of a rare form of cancer.

Though the number of women who may develop the disease is small, there is apparently no way to identify those who are likely to develop it — making it a source of potential concern to all women with the implants.

Among women who do not have implants, the cancer — anaplastic large cell lymphoma, or ALCL — develops in the breast tissue of about 3 out of 100 million women nationwide. [..]

“It raises a red flag about what other immune disease could be occurring that are not obvious,” said Diana Zuckerman, president of the National Research Center for Women & Families.

The FDA based its announcement on a review of scientific literature between 1997 and last May, which reported 34 cases of ALCL in women with breast implants, as well as other information from international regulatory agencies, scientific experts and implant manufacturers, which turned up additional cases. […]

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Some Hidden Choices in Breast Reconstruction

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Natasha Singer, New York Times: December 23, 2008

For many cancer patients undergoing mastectomies, reconstructive breast surgery can seem like a first step to reclaiming their bodies.

But even as promising new operations are gaining traction at academic medical centers, plastic surgeons often fail to tell patients about them. One reason is that not all surgeons have trained to perform the latest procedures. Another reason is money: some complex surgeries are less profitable for doctors and hospitals, so they have less of an incentive to offer them, doctors say.

“It is clear that many reconstruction patients are not being given the full picture of their options,” said Diana Zuckerman, the president of the National Research Center for Women and Families, a nonprofit group in Washington. […]

Implant surgery is the most popular reconstruction method in the United States. Often performed immediately after a mastectomy, it initially involves the least surgery usually a short procedure to insert a temporary balloon-like device called an expander and the shortest recovery time.

But implants come with the likelihood of future operations. Within four years of implant reconstruction, more than one third of reconstruction patients in clinical studies had undergone a second operation, primarily to fix problems like ruptures and infections, and a few for cosmetic reasons, according to studies submitted by implant makers to the Food and Drug Administration. (Reconstructive patients are more likely to develop complications after implant surgery than cosmetic patients with healthy breast tissue.)

“Patients should not necessarily accept the first thing they hear as the end-all, because that is not necessarily the full story,” Dr. Allen said.

[…]

Read the original article here.

Silicone: Now a Solid ‘Maybe’

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Melissa Healy, The Los Angeles Times: November 27, 2006.

The days before Thanksgiving are typically quiet in the offices of plastic surgeons. But a long-awaited decision to approve silicone breast implants for women older than 22 prompted a flurry of excited calls and inquiries last week from prospective patients. […]

The agency’s decision “does create a whole host of questions” for women considering silicone breast augmentation and for the doctors who perform those procedures, said Dr. Walter Erhardt, chairman of the American Society of Plastic Surgeons’ public education committee. […]

Cleared but questioned

The FDA’s approval — after 14 years of study — had been expected to end the controversy around silicone gel implants.

The devices were pulled from the general marketplace in 1992 amid concerns that they could rupture and endanger women, possibly contributing to autoimmune diseases. Although a link to health problems was never proved, long-term safety has remained an issue. In the meantime, the implants have remained available to cancer survivors and a wide range of women who agreed to enroll in studies of the implants’ safety.

But the new recommendations present patients and their plastic and aesthetic surgeons with additional uncertainties: Who will pay for the recommended MRI scans? What danger does the FDA foresee if patients, as expected, fail to get them? Does the FDA consider that a ruptured implant device — even one that presents no discomfort or proven danger to the patient — must necessarily be surgically removed and replaced? If so, whose financial responsibility would that be?

“Do you think [insurance companies] are going to say, ‘No problem, we want what’s best for the patient?’ ” asks plastic surgeon Marcel Daniels of Long Beach. “No. A lot of third-party payers have ruled out payment for any treatment — including complications — related to breast implants.”

What to do if those MRI scans detect cracks or breaks in an implant “is another conundrum that’s created by this [FDA] recommendation,” said Erhardt, of Albany, Ga. By calling for costly MRIs to detect silent ruptures and potential replacement surgery in such cases, the FDA is suggesting to patients and physicians that leakage may present safety concerns. “But we still don’t have science that [a silent rupture] creates a harmful situation for the patients. And the FDA hasn’t addressed that either,” Erhardt said. […]

The specialized MRI images required to detect the integrity of a breast implant typically cost between $1,500 and $1,800, said Diana Zuckerman, director of the National Research Center for Women & Families, a nonprofit research and education organization in Washington, D.C. Costs at some centers can reach up to $4,000, and many women would have to travel long distances to get the recommended images, added Zuckerman, whose organization testified against the latest silicone implant approval.

“These young girls are often going into debt that they can’t really afford to get out of, and they’re paying for something on installment that they can barely afford,” Zuckerman said. “I certainly think any woman who is not affluent would be crazy to choose silicone because of the additional cost.” […]

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FDA Ends Ban on Silicone Implants

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David Brown and Christopher Lee, The Seattle Times: November 18, 2006.

The Food and Drug Administration ended its 14-year ban on the cosmetic use of silicone breast implants yesterday, despite lingering safety concerns from some health advocates.

The FDA is requiring that manufacturers tell women that the implants “are not lifetime devices” and that most recipients will need at least one additional surgery to remove or replace their implants. The agency is requiring the makers, Mentor Corp. and Allergan Inc., to conduct an extensive study of at least 40,000 implant recipients over the next decade and provide their findings to the government. […]

Silicone implants were first marketed more than 30 years ago, but a moratorium was placed on them in 1992 after many women who had received them reported pain, deformity and serious illness caused when the implants ruptured or leaked. At the time, the FDA concluded there was “inadequate information to demonstrate that breast implants were safe and effective.” A major implant manufacturer, Dow Corning Corp., was pushed into bankruptcy because of lawsuits stemming from the problematic devices. […]

Diana Zuckerman, president of the National Research Center for Women and Families, said the approval was the product of corporate lobbying rather than good science.

Zuckerman, a former Capitol Hill staffer who has worked on breast implant safety issues for more than 15 years, said too little is known about the long-term health risks of the implants. She said what is known indicates that some women will experience joint pain, chronic fatigue and leakage. […]

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Implants, Mastectomies Linked to Problems

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Lindsey Tanner, Associated Press: December 5, 2005.

Breast implants in women who have undergone mastectomies often result in complications that require more surgery, a study in Denmark found.

Over a period of up to four years, about one-third developed at least one potentially serious complication, including thick, tight scarring and infections, the researchers reported. Implant ruptures were rare, with only five reported among the 574 Danish women studied.

Overall, about 20 percent of the women studied required surgery to treat the problems, according to the study by Danish Cancer Society researchers and scientists at the International Epidemiology Institute in Rockville, Md.

One surgeon said in an accompanying editorial that the numbers are “alarmingly high and arguably unacceptable.”

The study appears in the December issue of Archives of Surgery. It was paid for by the institute, which receives funding from the Dow Corning Corp., a former maker of silicone breast implants.

Diana Zuckerman, president of the National Research Center for Women and Families, said the complication rate for implants in mastectomy patients is actually much higher than the study suggests.

Most participants got implants several weeks after breast removal surgery, whereas most U.S. mastectomy patients who choose implants get them when their breasts are removed, Zuckerman said. That method, involving a single round of surgery, is often easier psychologically because women wake up from their mastectomies with refashioned breasts, but it is also more stressful on the body, she said.

Also, she said the participants in the study did not undergo MRI scans, which are the best way to detect ruptures.

“This study is really missing the boat,” said Zuckerman, whose group has opposed efforts to return silicone implants to the market.

All of the women studied got implants, most of them made of silicone.

Silicone implants have been restricted in the United States for over a decade because of fears that ruptures and leakage might damage women’s health. But some mastectomy patients have continued to receive them.

The American Cancer Society estimates more than 200,000 U.S. women will be diagnosed with breast cancer this year. At least half will have mastectomies, and Zuckerman said about two-thirds of those patients choose some type of reconstructive surgery. […]

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