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FDA Rarely Uses Its Power to Recall Dangerous Medical Devices. Why Not?

We Are Quoted
Meg Bryant, MedTech Dive: August 31, 2018.

The FDA has the authority to recall dangerous and risky medical devices, but it has rarely done so, largely relying on manufacturers to take necessary actions when a product defect or spike in serious adverse incidents occurs.

Since Congress passed the medical device amendments to the Food, Drug & Cosmetics Act in 1976, the agency has used its 518(e) mandatory recall authority just a handful of times. In 1991, the FDA ordered Medline to recall its Dynafeed enteral pump due to design flaws and failure to comply with good manufacturing practices. The agency issued three mandatory recall notices the following year and in 2008, recalled Nebion’s MRI device, citing lack of FDA approval and safety and effectiveness data, as well as noncompliance with GMPs.

There have been some recalls under federal consent orders, and the FDA has in four cases taken the unusual step of banning a medical device. The first time was in 1983 when it banned prosthetic hair fibers used to treat baldness because of serious risks including infections. Then in 2016, the agency simultaneously banned powdered surgeon gloves, powdered patient examination gloves and absorbable power used for lubricating surgeons’ gloves. The danger: Residue from the powder could be left behind in the body cavity, causing inflammation and scarring that could lead to complications later on. In addition, bits of latex from the gloves could bind the powder and be inhaled, putting people with latex allergies at risk.

Given Bayer’s recent decision to stop selling the Essure birth control device, following years of unmitigated safety concerns and mounting patient lawsuits, and the release of the Netflix documentary, The Bleeding Edge, many are questioning why the FDA seems so reluctant to wield its recall authority.

“The FDA has not taken them off the market, has not rescinded approval for specific uses, has not done a mandatory recall and has tried to put out [a] warning that the agency knows is not going to be effective,” said Diana Zuckerman, president of the National Center for Health Research. “They do that all the time.”

‘Insurmountable threshold’

“Once products are on the market, it’s almost an insurmountable threshold to get the agency to take action to pull them from the market,” said Michael Carome, director of Public Citizen’s Health Research Group. “In the case of [Bayer’s] Essure, had the company not voluntarily acted, I suspect FDA would not have pushed them to pull it from the market, based on statements they made over the last few years in the face of concerns.”

Approved in 2002, Essure was associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes and migration of the device into the pelvis or abdomen. The FDA required the addition of a boxed warning and patient decision checklist to the product’s labeling and in April restricted sales of Essure, but did not call for its withdrawal from the market.

That’s not unusual, says Jodi Scott, partner in Hogan Lovells’ Denver office and former FDA counsel. “By and large companies are pretty responsive to a very direct FDA request to take action,” she tol MedTech Dive. “And while I’m sure it doesn’t work in 100% of the cases, I will tell you it probably works 99% of the time.”

Mandatory recalls are also costly for FDA to take. According to the agency, the estimated annual reporting burden associated with section 518 actions is 1,098 hours.

As a last resort, FDA will order a recall, but it’s a lot easier to “look the company in the eye and tell them we think you need to do a recall and have them do it voluntarily,” Scott said. “And it happens much faster. To go to court and get an order takes a lot of time.”

It can also take time to sort out signals detected through the agency’s MDR reporting and Sentinel systems. If officials think there is an imminent risk of harm, they will do an analysis to determine whether the company needs to take some field action, which may or may not involve a recall. “You have to balance the risk and benefits,” Scott said, noting implants are often left in place and monitored when issues arise because of the risks associated with taking them out.

Still, she insists FDA “is not shy” about telling companies when reparative actions fall short and they need to do more. “But it’s all sort of informal, not invoking the mandatory recall authority,” she added.

Problem begins in premarket process

Critics say the real problem precedes FDA’s failure to act once a device is on the market and lies with the process used to bring most moderate and high-risk devices to market. Under the 510(k) premarket notification, companies need only to demonstrate that a device is substantially similar to another product in the market in terms of its intended uses and technological features. In most cases, no clinical trials are required.

Even when clinical trials are required for novel devices subject to premarket approval, they aren’t always randomized. And in cases where devices are given conditional approval and required to undergo postmark testing, the FDA is often lax about seeing that companies complete studies in a timely manner, they argue.

“They allow these studies to drag on for years and years and years, and by the time the studies are done, or if they are ever done, nobody needs the information anyway anymore because the product’s not on the market anymore or the product has changed so much that the information you have about the product that was being sold three years ago is not relevant to the product being sold today,” Zuckerman said.

Zuckerman pointed to the case of breast implants. The FDA approved two silicone gel-filled breast implants in 2006, with the proviso the manufacturers — Johnson & Johnson’s Mentor and Allergan — each would study 40,000 women for 10 years. Neither completed the studies, which involved cumbersome online questionnaires and did not provide any incentives for women to complete them. 

Too close to industry?

“Ultimately, the agency is too industry-friendly,” Carome told MedTech Dive. “They view the industry as a partner rather than a regulated entity.” He believes the adoption of user fees has made the situation worse by allowing industry to negotiate benchmarks for FDA product reviews and other activities in return for payments for reviewing product submissions and other services.

Meanwhile, a 2016 proposal to ban electrical stimulation devices intended to treat people with mental or behavioral disorder that who exhibit self-injurious or aggressive behavior has yet to be finalized.

At the time of the proposed ban, only one facility in the U.S. was using the devices: the Judge Rotenberg Educational Center in Canton, Massachusetts. “Our primary concern is the safety and well-being of the individuals who are exposed to these devices,” William Maisel, chief scientist and deputy director science at CDRH, said at the time. “These devices are dangerous and a risk to the public health — and we believe they should not be used.”

No one is arguing the FDA should recall or ban every device that poses an imminent risk of harm, Zuckerman said. But in cases where FDA opts to keep a product on the market despite well-known risks, it should use the powers it has to require timely and well-designed studies that demonstrate safety and effectiveness versus available alternatives. The agency should “use the teeth it has,” she argued. […]

Read original article here.

Infection

Augmentation Risks, Reconstruction Risks

All surgical procedures come with immediate risks, like reactions to anesthesia, bleeding, and infections. Infections can happen after breast augmentation surgery if bacteria gets into the incision site. These infections can be serious. The Food and Drug Administration (FDA) warns that toxic shock syndrome, a life-threatening complication from bacterial infections, has been reported following breast augmentation surgery.

Plastic surgeons try to minimize the risk of infection during surgery by keeping the incision site and the implant sterile. There are different ways that surgeons put the implant into the breast to reduce the chances of infection.

Symptoms of infection include redness, heat, drainage, or swelling around the area of the stitches or scar. Other symptoms include a fever, rash, nausea, fatigue, nipple discharge, and vomiting. After augmentation surgery, you should monitor your breast(s) for signs of an infection. If you develop symptoms, you should see a doctor immediately.

Some women develop infections near or related to their breast implants months or years after surgery. Some studies have shown that textured implants, which have a bumpy surface, provide an ideal surface for bacteria to live and grow. If you have textured breast implants, you may be at a greater risk for an infection. Some women have also reported infections caused by saline filled implants that were contaminated with bacteria. If a contaminated saline filled implant ruptures,  the bacteria or fungus can get out into the surrounding area or travel throughout your body. This can be very dangerous. If you notice a change in the size or shape of your implant around the same time as symptoms like swelling, redness, or fever, you should see a doctor immediately.

If you develop an infection related to your breast implants, you will need antibiotics. Some women will require hospitalization and intravenous antibiotics (medications that go directly into your bloodstream to fight off the infection). If your infection doesn’t respond to antibiotics, your implants will need to be removed.

It is important for you to know that swelling can be a symptom of an even more serious medical issue called Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system caused by breast implants. ALCL is also more likely to develop around textured breast implants. If the swelling is not eliminated by the antibiotic, immediately ask your doctor to get the fluid tested for ALCL.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Breast Implants Have Harmed Me. How Can I Report this to the FDA?

Have Questions?

Breast implants do not last a lifetime and many women report complications that they did not expect. Many women with breast implants experience implant rupture, capsular contracture, breast or body pain, joint pain and other autoimmune symptoms, mental confusion, rashes, and even cancer of the immune system (ALCL). If you have experienced any of these complications, you could help other women by reporting it to the FDA.

The FDA is responsible for protecting patients and consumers by warning them about the risks of medical products, and taking products off the market if the risks outweigh the benefits.  The main way they gather information about the risks of breast implants (and other types of implants) is when doctors, nurses, and patients report problems through the FDA’s Voluntary MedWatch Report. If the FDA sees that complications are more serious or more frequent than expected, we will urge them to require manufacturers to conduct better research or to pull the product from the market.

You can report any problems caused by your breast implants using this short online form.

You don’t need to remember exactly when the symptoms or complications started, but give an estimate of how long it was after you got your implants.  If you don’t know the exact brand or model of your implant, you should report your problems anyway, but include the brand if you can.  From 2000 to 2015, most breast implants in the US were made  by either Mentor or Allergan (also called Inamed or McGhan).

If you are in Canada, you can report medical device complications to Health Canada using this short online form.

If you have problems completing the form, ask for help at info@center4research.org

The Human Tragedy of Poorly Regulated Medical Devices Gets the Spotlight in a Netflix Film

We Are Quoted
Amy Martyn, Consumer Affairs: July 27, 2018.

The motel where Ana Fuentes arrives one evening with her young daughters charges $110 for a single night and doesn’t offer weekly discounts. Fuentes asks the cashier for a moment so she can think about it.

Outside, the camera captures an anguished look on her face. It’s clear she can’t afford the expense. She books the room anyway. “Do you like it?” she asks her girls as they excitedly unpack their bags.

The family used to have an apartment, but Fuentes had to visit the emergency room so often that she lost her job, her daughters explain on camera.

Such situations aren’t rare in the United States, where experts have repeatedly warned that millions of Americans have almost nothing in savings and are a single medical disaster away from financial ruin. The problem is compounded nationwide by costly healthcare, lack of access to paid sick leave in the workforce, or a combination of the two.

But Fuentes’ story, like dozens of others featured in an upcoming expose about the medical device industry, has a particularly cruel twist. She says in the film that she was healthy until a doctor convinced her to undergo what was supposed to be a routine, non-surgical medical procedure — getting small birth control implants permanently embedded into her fallopian tubes.

The $155 billion medical device industry has mostly avoided the type of scrutiny that drug companies and health insurers sometimes face from elected officials and others. On Friday, a documentary about the device industry and patients like Fuentes called The Bleeding Edge is set to go live on Netflix, bringing what advocates hope will be widespread attention to an industry increasingly characterized by lax safety standards, enormous power in the operating room, and horrific side effects.

“If you’re going to have something implanted in your body for potentially the rest of your life, wouldn’t you like it to be really well-tested beforehand? Is that really too much to ask?” says Dr. Diana Zuckerman, a health policy analyst who has worked in the White House and as a staffer in Congress.

The current president of the National Center for Health Research, Zuckerman and the other researchers at her non-profit are among the few to have taken interest in faulty medical devices.  

Diving into the medical device industry

Hollywood directors Kirby Dick and Amy Ziering knew they wanted to make a documentary film about preventable medical injuries, Dick tells ConsumerAffairs, but that was about it.

Sitting in on one patient advocacy meeting for research, they caught a presentation that Zuckerman gave about the medical device industry and the ease with which questionable products get on the market. They decided that they had found their story.

The team interviewed approximately 70 patients to make their film, Dick tells ConsumerAffairs. The film also includes interviews with numerous whistleblowers, such as doctors, former Food and Drug Administration (FDA) researchers, and one medical device sales rep who requested anonymity in exchange for speaking on camera.

Dick and Ziering were previously nominated for an Oscar for The Hunting Ground, their documentary about sexual assault on college campuses. Another earlier film, The Invisible War, is an expose about sexual assault in the military.

But persuading people to speak out against the device industry made for the most challenging interviews they’ve done, Dick tells ConsumerAffairs. (A medical device industry lobbyist touts in one scene that the industry is more powerful than some national governments.)

The “E-sisters”

As the film and the research it is based on shows, the problem is bigger than any single device. The Bleeding Edge captures the story by focusing  on four implants — three of which were used exclusively women’s reproductive organs.

The narrative is driven forward by the story of the “E-sisters,” or the activists who say that they suffered debilitating side effects after receiving the permanent birth control implant Essure.

For years, the “E-sisters” have organized a grassroots campaign to convince regulators to ban Essure from doctors’ offices. That goal seemed like an uphill battle until last week, when Bayer suddenly released an announcement that Essure will no longer be sold in the United States by the end of the year.

Bayer frames the move as a “business decision.” The announcement came one week before the Netflix documentary was scheduled for release.

“I’m very glad that these issues are getting this kind of attention, and I hope that Bayer’s decision to take Essure off the market won’t take away from the bigger message of the film,” says Zuckerman, “which is the whole process for devices that makes no sense at all.”

“Why in the world would you want to have a regulatory agency in our government, the FDA, having much lower standards for devices than they do for prescription drugs?”

Essure implants

The story of Essure, in particular, only saw the light-of-day thanks to the “E-sisters,” who count 30,000 people in their Essure Problems Facebook group and have convinced numerous elected officials, doctors, and even early clinical trial participants to join their cause.

“One of the things that is disturbing to me is that these issues only came to light because of the work of victims,” former Representative Mike  Fitzpatrick (R-Pa.) said in an interview several years ago.

Women who agreed to participate in clinical trials for Essure in the late 90s have said that they there were sold on a pitch to get a free, non-hormonal, and permanent birth control that was already proven safe.

A nickel coil, the size of a ballpoint pen, would be placed in each fallopian tube. That was designed to create an inflammatory response so that the coils would become permanently encased in the resulting scar tissue.

Regulators with the FDA approved the device in 2002, despite admitting that they knew little about the long-term side effects of such a procedure, as footage that the E-sisters had obtained captures. What’s more, numerous clinical trial participants later said that their painful side effects were not included in the company’s official data.

Doctors not long after began using the devices without questioning potential risks. “For some reason we did that to women. And I did that, too,” Dr. Shawn Tassone, an Austin-based gynecologist, tells ConsumerAffairs.

Insurance and profit margins

The sales representatives who taught doctors how to place the devices — something that Bayer has defended as a common industry practice — offered no instructions on how the device should be removed if there were side effects.

“We were just told from the very beginning that even if they’re misplaced, you don’t have to remove them,” Tassone remembers.

The role that insurance coverage may have played isn’t examined specifically in The Bleeding Edge, but testimony from patients and doctors suggests that getting insurers to cover Essure proved much easier than getting them to cover removal.

Tassone remembers that both private plans and Medicaid paid fairly generously for the Essure procedure, especially considering that inserting Essure was much cheaper and less labor-intensive than tubal surgery, the older sterilization procedure.

“If you think about a tubal ligation where you go to the operating room, it’s $400 [in profit] give or take,” he say. “Essure in the office, after you subtract the amount of the device, it’s probably $1100.”

Treating any resulting side effects proved impossible for women navigating unfamiliar territory. Angie Firmalino, the New York City mail carrier who founded the E-sisters network, initially seeked help from a doctor who morcellated the coils into small pieces — sending the nickel elsewhere in her body.

Connecting patients with doctors who are willing and able to properly remove the devices, as well who are able to code it correctly so that insurance will pay, has since become one of the E-sister’s major tasks.

Tassone, for his part, implanted his last Essure device in 2013. He says it was a call from another doctor who convinced him not to perform the procedure anymore; a woman with Essure apparently had gotten pregnant, he was told, which can be extremely dangerous for both the baby and the mother. One researcher has counted 303 fetal deaths linked to the device.

Tassone has since switched sides, counseling the E-sisters online and in the operating room. He estimates that he has conducted 600 Essure removal surgeries.

Trust remains despite ban

In recent years, the advocates have convinced the FDA to add a black box warning to Essure. Later on, they were able to help pass a rule which requires doctors to give patients more detailed warnings about the product.

But that didn’t appear to stop most doctors from trusting the device. The American College of Obstetricians and Gynecologists continues to say on its website that lasting pain from the procedure is “rare.” By contrast, nearly 27,000 reports have been filed to the FDA’s “adverse event” report database describing health problems caused by Essure and 16,000 lawsuits have been filed here. An estimated 750,000 women worldwide have undergone the procedure.

Now that Essure is off the market, doctors may be more willing to attempt removal surgery, Tassone says, something he thinks is necessary but frightening

“They’re going to think its not a big deal to take out,” he worries. (More detailed advice about removal surgeries is offered on the Essure Problems page).

Generally, before any major surgery involving a permanent implant, researchers advise patients to press doctors on the specific devices that will be used. Zuckerman, the health policy analyst who helped inspire the Netflix film, recalls that even she struggled to get specific answers when she asked a doctor what brand of hip he would choose for her own surgery.

The procedure ultimately went well, she says, but trying to search for good data comparing brands beforehand was nearly impossible.

“In the vast majority of cases, the surgeons are still quoting the company data,” Zuckerman says. “The company’s data on humans is nonexistent —  at least publicly.”

Breast Implant Problems? Obamacare Can Help!

Private Insurance

If you’re having problems with your breast implants, there’s a chance you could benefit from the Affordable Care Act (ACA, or “Obamacare”).

An important change was made when the Affordable Care Act was passed: health insurance companies could no longer refuse to pay for health care arising from a pre-existing condition. Pre-existing conditions are health problems you had before joining an insurance plan. For example, your health insurance company can’t refuse to cover your insulin medication if you were diagnosed with diabetes before buying their plan. This is important because before the Affordable Care Act, insurance companies considered breast implants a pre-existing condition. They refused to cover any breast implant problems and sometimes even problems that occurred in the breast tissue.

Now insurance companies are usually required to pay for “medically necessary” services. Most insurance companies define “medically necessary” as a service that is required to improve your health or keep you healthy. Although some insurance companies say they do not cover services related to cosmetic surgery, many have exceptions when those services are deemed medically necessary. It is important that you read the policies carefully before you choose!

Based on our experiences working with women having problems with their breast implants, we have found that many companies consider removal of breast implants to be medically necessary for these conditions:

  • Ruptured silicone gel breast implants
  • Severe capsular contracture
  • Infections that don’t go away
  • Chronic breast pain
  • ALCL (a rare cancer of the immune system)

Additionally, insurance companies such as Aetna, UnitedHealthcare, and Cigna tend to have good coverage for medically necessary breast implant removal if you meet their criteria that include the conditions listed above. The language that each policy uses can vary by state and plan type, so be sure to look for the language regarding breast implants in the specific plan you are considering.

There is a window of time called “Open Enrollment” each year when you are able to sign up for a plan through the health insurance marketplace.  Read below to see how to sign up for health insurance through the Affordable Care Act or Medicaid.

How Do I Sign Up During Open Enrollment?

During open enrollment, you will have the opportunity to choose an affordable health insurance policy through the government’s Health Insurance Marketplace. This Marketplace helps you to shop for insurance plans that everyone can afford.  For more information, read here: https://www.healthcare.gov/quick-guide/.

While open enrollment period for coverage in 2023 through the Health Insurance Marketplace has ended in most states but you’ve recently lost your health insurance coverage due to recent job loss, or have had a major life event, like getting married or having a baby,  you may be eligible to sign up for health insurance outside of the Open Enrollment period. If you follow this link: https://www.healthcare.gov/screener/ you can check whether you might be eligible for coverage in 2023 outside of the enrollment period.

This Marketplace allows you to shop for insurance plans and apply savings based on your household income. The lower your income, the less you’ll have to pay. Want to know how much your health insurance plan will cost through the Affordable Care Act? Use this calculator to find out.

Is Medicaid an Option?

In many states, Medicaid is available for free to any individual or family under 133% of the poverty line (about $30,000/year for a family of 4). Medicaid provides coverage for surgery or services that a doctor determines are medically necessary. You can find out if you are eligible for Medicaid at www.healthcare.gov.

Read here for more information on getting Medicaid coverage for your breast implant removal surgery.

Unfortunately, fewer people are eligible for Medicaid in states that did not adopt the Medicaid expansion provided by Obamacare.

 

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Interference with Breast Cancer Detection

Augmentation Risks, Reconstruction Risks

Breast implants make it more difficult to detect breast cancer. If you are considering getting breast implants or already have breast implants, it is important to know how they can make mammography and breast exams less accurate.

Mammography is used to screen for and detect breast cancer. Breast implants make mammography less accurate because they can hide cancer that is growing behind or around the implant. 1 According to a research study published in the British Medical Journal, women with cosmetic breast implants who are diagnosed with breast cancer, are more likely to die from the disease compared to women without breast implants who are diagnosed with breast cancer.2 The study found that women with breast implants were more likely to be diagnosed with a later stage breast cancer, compared to women diagnosed with breast cancer without breast implants. This likely occurred because implants interfere with mammography, making it difficult to diagnose breast cancer early.

A mammogram is a type of x-ray. Breast tissue will look grey on the mammogram, and cancer will look white. In a mammogram, implants are also white and will look like a bright white orb. If there is cancer in breast tissue that is below or very near the implant on the mammogram, it probably will not be visible, and therefore won’t be detected.

Here is an example of what implants look like on a mammogram:3

Severe capsular contracture can interfere even more with the accuracy of mammography. It can also cause mammography to be unbearably painful. Capsular contracture is when the scar tissue capsule around the implant tightens and hardens. If you have severe capsular contracture, it may not be possible for you to have a mammogram.

If you have breast implants and need to have a mammogram, you should tell the technician that you have breast implants. You can go to a mammography center that has experience doing mammograms on women with breast implants. The technician will need to take extra x-ray pictures and will have to push your implants to the side, which can be painful.

Mammography also can cause breast implants to break (rupture) or leak. If you have silicone gel-filled implants, this rupture may not be noticeable, but it can cause pain or health problems. To prevent extensive leakage, it is important to have regular breast MRIs to check for silicone gel leakage. If the rupture is not detected, silicone gel can leak through the body and cause serious medical problems.

If you have silicone gel breast implants that are leaking, they can cause lumps (silicone granulomas) that can be mistaken for breast cancer. It can also be difficult to know when a lump really is breast cancer. If you have any lumps, be sure to have them checked for cancer right away. If they are from leaking silicone, it is important to have your implants removed.

All articles have been reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Complication Rates Following Breast Reconstruction

Reconstruction Options
Bennett KG et al. Comparison of 2-Year Complication Rates Among Common Techniques for Postmastectomy Breast Reconstruction. JAMA Surgery. 2018; 153(10):901-908.

Many women choose to have breast reconstruction after a mastectomy. There are many types of breast reconstruction procedures available, and each has benefits and risks. It is important to understand those potential risks and benefits when deciding what type of reconstruction, if any, is best for you. Research shows that the type of reconstruction affects short-term and long-term complications.

The two main types of reconstruction are 1) breast implants and 2) tissue transfer, also called “flap” procedures. A “flap” procedure uses a patient’s own tissue from somewhere else on their body (such as their stomach) to create a new breast. Overall, there are higher risks of short-term complications with “flap” procedures than with breast implants, but the flaps last much longer with fewer complications in the long term. 4 5

A study published in the Journal of the American Medical Association in 2018 followed more than 2,300 patients for 2 years after they had reconstruction. About half of the patients had reconstruction of both breasts. The study evaluated different types of breast reconstruction and three types of complications: infection, the failure of the surgery, and the need for another operation to fix any problems. The study measured complications in each breast, not in each woman.

The research study found that the complication rate for all patients who had breast reconstruction was 33%, as shown in the table below. Forty-seven percent of “flap” patients had complications after surgery compared to 27% of patients who got breast implants. Some “flap” procedures had more complications than others. For example, the SIEA flap, which uses fat, skin, and blood vessels from the belly to reconstruct the breast, had a very high complication rate of 73%. In contrast, the TRAM flap, which uses muscle, fat, and skin from the abdomen, had a 38% complication rate.

While the study found that there were higher risks of short-term complications with “flap” procedures, other research shows that more breast implant complications can occur over time. Studies that followed women with breast implants for more than 10 years have found that about 50% of women will need additional surgery. 6 7 8

The study also found that a woman’s treatment decisions impact her risk of complications, such as undergoing radiation or chemotherapy during or immediately after reconstruction. Women undergoing radiation were 2 times more likely to develop complications and women undergoing chemotherapy were 1.5 times more likely to have complications. Other factors that can affect a patient’s risk of complications are high BMI and age. The research also found that women who delayed breast reconstruction were about 2 times less likely to develop complications compared to women who had reconstruction right after mastectomy.

Read the original article here.

Breast Implant Illness: Two Metro Women Say Implants Caused Years of Complications

Helpful Articles, ,
Ben Oldach, WHO TV: May 21, 2018.

Breast implants are the most popular form of plastic surgery in the United States. Katie Krug’s followed a botched breast reduction.

“There were quite a few people that asked me when I was in a bathing suit if I had open heart surgery, so it was something that I was really self-conscious about,” said Krug. […]

“About a year later is when I started noticing some really small symptoms. I was tired a lot more, started having some brain fog, started being really sensitive to smells, and then it just seemed like every year it got worse,” said Krug. […]

Both women say they went to doctors who couldn’t figure out what was wrong, all while new symptoms were developing. […] and after doing some research found a Facebook group of 35,000 women, all claiming similar symptoms.

The women in the group believe they are suffering or had suffered from something being called breast implant illness, although experts say it’s a symptomatic reaction rather than an actual disease. […]

Miller and Krug consulted with a local plastic surgeon who performs explants and had theirs removed. They say they immediately started feeling better. […]

Read the original article here.

After 17 Years with Breast Implants, Princeton Woman Leads Calls for More Education, Safety

Helpful Articles
Marie Saavedra, WFAA: April 16, 2018.

A North Texas woman says her implants were making her sick. Now, she’s lending her voice to the call for more information to be shared between the FDA, doctors and patients.

Jamee Cook was 21, engaged to be married and a paramedic when she made a decision that would shape the rest of her life.

“I was really active. Healthy, Young, skinny,” she said. “I was always really really flat chested and wanted to be more proportionate.”

At age 21, Cook chose to get breast implants. At 40, it is her biggest regret.

“I mean, I made this decision and I own it,” she said. “And I do feel guilty about it because it took a lot of things away from me.”

She says that included her health. Three years after surgery she developed an auto immune disease.

“Then it went downhill, just chronic fatigue, swollen lymph nodes all the time, chronic sinus infections,” Cook said. “I couldn’t get out of bed, I was having migraines two or three times a week, and I had three young kids at home!”

She says doctors had no more answers, which left her feeling helpless. Cook turned to the internet and researched, and she came to realize her implants could be the source. She was certain when she removed them after 17 years.

“I still battle fatigue off and on, but the majority of my other symptoms went away immediately,” she said.

Cook then gained new purpose. She created the group Breast Implant Victim Advocacy, a community of thousands women who say implants made them ill. She lobbied for implant safety in Washington. All of it, driven by a simple goal.

“I think that a lot of women don’t get the information they need to make a fully informed decision,” she said.

Last year, the American Society for Aesthetic Plastic Surgery said surgeons performed 333,329 breast augmentations. We asked Dallas plastic surgeon Dr. Lawrence Weider about what warnings patients can currently expect to hear from their doctors.

“There’s a whole host of risks that we discuss,” said Dr. Weider. “We have a several page consent for that we go through with them.”

But Cook argues there’s more to be done. Right now, The FDA is researching the ties between a specific type of implant causing a rare lymphoma, and last month a woman suffering from that cancer sued an implant maker in California. […]

Read the original article here.

Making Your Decision

Augmentation Decision

Deciding whether to get breast implants is a big decision. Before going forward, you should know as much as you can about the types of implants available, how much they will cost you in the short-term and long-term, and immediate and future health considerations.

Breast Implant Types

There are two types of implants: saline-filled and silicone gel-filled. Saline implants consist of a smooth or textured silicone envelope filled with saline (salt water). Silicone gel implants consist of a smooth or textured silicone envelope filled with silicone gel (a synthetic material). Breast implants also come in different shapes and sizes.  There are different reasons why some individuals prefer certain implants over others. You can read more about the different types of implants here.

Implant Costs

In 2016, the all-inclusive cost for initial implant surgery was between $5,000 and $8,000. Silicone gel implants usually cost about $1,000 more than saline implants.

Complications, such as infection, rupture, pain, or asymmetry, are very common. You can read more about breast implant complications here. Breast implants are not lifetime devices. You should expect to need additional surgery at some point, which can cost as much, if not more, than the initial surgery. Additional surgery can be needed because of health issues or cosmetic problems, and is rare during the first year but becomes more likely every year after that.  Some women have reported developing autoimmune problems or connective tissue disorder after receiving their implants. In addition, breast implants can cause Anaplastic Large Cell Lymphoma (ALCL), a rare cancer of the immune system.

All breast implants eventually break and leak, which requires removal and/or replacement.  Leakage is more obvious with saline implants, which usually deflate quickly, while silicone gel-filled implant ruptures are less noticeable. Because most women don’t notice when a silicone gel implant ruptures, the FDA recommends having breast MRIs regularly to detect ruptures that have no symptoms.  When silicone breast implants were first approved, the FDA recommended that all women undergo a breast MRI 3 years after getting breast implants, and every other year after that. However, because of the expense and the reluctance of plastic surgeons to encourage MRIs for silent ruptures, very few women followed the FDA’s advice.  As of October 2020, FDA now recommends an MRI 5-6 years after the initial surgery and every 2-3 years after that.

Breast MRIs to check for implant leakage cost about $2,000 and are not usually covered by health insurance, so that is a substantial expense to be aware of.

Health Considerations

Saline Implants

  • All breast implants interfere with mammography, making mammograms less accurate.
  • The silicone envelope of the implant will tear or fall apart over time. This can cause the implant to leak and deflate, which is usually noticeable.
  • If the implant ruptures, the saline solution is usually not dangerous, but after being in the body it may contain bacteria or mold that can sometimes cause infections
  • Textured implants are more likely than smooth implants to cause Anaplastic Large Cell Lymphoma (ALCL), a type of cancer of the immune system.

Silicone Implants

  • All breast implants interfere with mammography, making mammograms less accurate.
  • The silicone envelope of the implant will tear or fall apart over time, causing the implant to leak.
  • Leaks aren’t usually obvious, so silicone gel can travel to other parts of your body for years before the leak is detected. Silicone gel can be impossible to remove once it travels to breast tissue or other organs, such as the lungs or liver.
    • To avoid the health risks of leaking silicone gel, women with silicone gel implants need regular breast MRIs to check for silicone gel leaks. The FDA now recommends an MRI 5-6 years after the initial surgery and every 2-3 years after that.
    • Leaking silicone gel can cause pain or swelling. It could cause allergic and/or autoimmune reactions.
  • Textured implants are more likely than smooth implants to cause Anaplastic Large Cell Lymphoma (ALCL), a type of cancer of the immune system.

If you have a family history or a diagnosis of an autoimmune or connective tissue disease, you should know that implants have not been tested for safety in women with those conditions because of health concerns. You can read more about autoimmune reactions here.