At least 12 deaths in the last two years have been linked to a popular treatment for obesity, the U.S. Food and Drug Administration warned in a letter to health care providers earlier this week. In most cases, patients died within a month of having a liquid-filled balloon inserted in their stomachs, a procedure that limits the amount a person can eat and helps them feel fuller faster.

Two types of liquid-filled balloon systems have been on the market since 2015: the ReShape Integrated Dual Balloon System and the Orbera Intragastric Balloon System. These balloons are inserted via a minimally invasive endoscopic procedure and are inflated with a saline solution once in place in the stomach.

The balloons are designed to remain in place for several months, while patients receive counseling on diet, exercise, and healthy lifestyle changes. In clinical trials for both devices, patients lost at least twice as much weight with these procedures than with diet and exercise alone.

But in August 2017, the FDA issued a warning about seven deaths that had been linked to the two types of liquid-filled balloons. At the time, the FDA said that it wasn’t clear whether those deaths were caused by the balloon systems, but that it was looking into the possibility.

This week, the agency revealed that five more deaths had been reported since last year’s warning, several of which were linked to perforations of the stomach wall after balloon implantation. In addition to the deaths, other complications related to the placement and use of these devices—such as inflammation of the pancreas, and the balloon filling with air or more liquid and getting too large—have also been reported.

The FDA approved labeling changes last week to reflect this new information and is encouraging doctors to closely monitor patients with intragastric balloons for complications. Health care providers should also talk with their patients about symptoms that could be signs of serious problems, the FDA said, and advise them on what to do if those symptoms occur.

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But the letter does not discourage all use of the Orbera and ReShape balloons. “While these devices remain an appropriate treatment option for some patients with obesity, patients should always discuss with their doctors which treatment option is best for them,” said William Maisel, MD, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, in an FDA brief.

Aurora Pryor, MD, director of the Bariatric and Metabolic Weight Loss Center at Stony Brook University in New York, treats patients with both Orbera and ReShape, along with other forms of bariatric surgery. She says doctors and patients should take the FDA’s letter seriously, but that overall, complication rates from these devices remain low.

“Any death in a patient raises red flags and concern, but you also have to consider the large number of people who are using these balloons and look at that proportionately,” says Dr. Pryor. Hundreds of thousands of these balloons have been implanted worldwide, she says, compared to just 12 deaths reported. In statements, Orbera and ReShape manufacturers cited mortality rates of lower than 0.01% and 0.06%, respectively.

“You can’t say that this is a completely safe operation—there are definitely some risks involved. And for a fair consent process, you have to discuss these things with your patients,” says Dr. Pryor. “But I do think if you’re aware of these complications, and you’re looking out for pain and other symptoms, these things can be managed if identified early.”

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Liquid-filled balloons are one of several options for patients considering surgical treatments for obesity. Patients who fit the criteria for traditional weight-loss surgery—usually a body mass index of 40 or higher, or 35 with other health problems—can also opt for a gastric bypass or a sleeve gastrectomy.

Like any surgery, these procedures also come with risks. But they’re generally considered very safe: One 2012 report found that mortality and complication rates for both gastric bypass and sleeve procedures were lower than those generally associated with gallbladder or hip replacement surgery. And according to the American Society for Metabolic and Bariatric Surgery, the mortality rate during the 30 days following bariatric surgery is around 0.13%.

“If people meet the parameters, I will strongly encourage them to have either a sleeve or gastric bypass procedure, as those are the most studied to be effective for weight loss,” says Dr. Pryor. “If somebody has a lower BMI or they don’t qualify for surgery or aren’t interested in surgery, that’s where other options, such as balloons, come in.”

A newer balloon system, called Obalon, is swallowed rather than inserted endoscopically, and is then filled with gas rather than with liquid. At this time, the FDA is not aware of any deaths or serious adverse events related to these newer devices, an agency spokesperson told Health via email. 

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When deciding on any treatment options, Dr. Pryor says, it’s important doctors and patients consider both the risks and the benefits. In the case of intragastric balloons, benefits can include not just weight loss, but also reductions in obesity-related complications like heart disease and diabetes. “Despite the FDA’s warning, I think the balloons are still an excellent procedure,” she says, “and an important option for many patients struggling with their weight.”

Photographer, author, and blogger Natalie McCain has spent the last three years building The Honest Body Project, a community focused on body and parenting-positivity. Her inspiring photo series have given a voice and a platform to several difficult topics that many moms struggle with, including postpartum depression and C-section anxiety. But now she’s taking the stage to share a vulnerable experience of her own: McCain was diagnosed with type 2 diabetes in late November. With her diagnosis came her desire to share her story and encourage other moms to prioritize their own health, before it’s too late.

In an eye-opening blog post, McCain admits she has neglected her own health to tend to the needs of her children—an experience many moms know all too well. “I had intense brain fog that I assumed was due to not getting enough sleep,” McCain wrote. “I had tingling in my fingers, but assumed it was from sleeping wrong on my arm or an old carpal tunnel injury. I started to feel weird after eating desserts, but it didn’t click that it could be from the sugar. I would often get headaches after exercise or upon waking,” she explained.

Despite her symptoms, she didn’t immediately see a doctor. “As moms, we tend to explain things away when it comes to our own health,” she wrote. “I didn’t take any of the symptoms seriously, even though my body was trying desperately to alert me that something was wrong.”

Time to Take Action

When her doctor told her that her A1C level—or the three-month average of blood sugar—was on the extremely high spectrum at around 300, McCain says she was overcome with anger, mostly at herself. She knew diabetes ran in her family, and as the doctor revealed she had ‘raging, out-of-control’ type 2, she wondered what she could have done differently.

“I exercised frequently prior to my diagnosis and I was not a junk food eating person,” she told Parents.com. “I didn’t think I was treating my body badly, but clearly my body was not thriving off of what I was fueling it with.”

To begin her road to better health, her doctor insisted on insulin, but her pharmacy wasn’t able to fulfill her prescription for a few days. Frantic for answers, McCain turned to a friend with expert knowledge on diabetes who suggested she shift her diet. “I started immediately and within two weeks my sugar readings were all at normal levels without ever starting medication,” she said. “I was in shock—as was my doctor when I returned to see her.”

Though McCain is now managing her type 2 diabetes with a strict, nutritional diet and exercise routine, she’s committed to helping other moms put their health first, so they can avoid a similar scary health experience. She wants to shed light on the many warning signals our bodies send—many of which are easy to miss or ignore.

Know the Warning Signs

It’s common for type 2 diabetics to go several weeks, months, or even years, without realizing something is off since the indicators aren’t always clear, explains Allison A. Vorderstrasse, DNSc, APRN, FAAN, an associate professor at NYU Rory Meyers College of Nursing. Many diabetics experience increased hunger or thirst, more frequent trips to the bathroom, and fatigue. These symptoms are all due to the fact your body isn’t receiving what it needs from fuel, Vorderstrasse explains.

But for moms, these warning signs could just feel like a result of any other jam-packed, overworked day: “A mom might think that feeling tired, hungry, or thirsty are part of the fatigue or lack of sleep associated with having children, family, or work-related responsibilities. She may be less focused on taking care of herself with these multiple competing demands for her time and attention,” Vorderstrasse says.

In the same way you listen to your gut about your children’s ailments, McCain urges mothers to seek medical attention for themselves sooner than later. It’s important to remember that what your children need most is a healthy, vibrant parent who will be around for a long time.

Don’t let shame get the best of you, McCain urges. “Being a body-positive activist, I have been preaching about loving your body for years. When I realized I wasn’t truly taking care of my health, I felt guilty. The symptoms went on for nearly a year, only getting worse with time,” she says. “I knew I needed to share my story to help raise awareness that part of self-love is not only celebrating and accepting your body, it is also being responsible for your health.”

This article originally appeared on Parents.com.

Like so many women, fitness influencer Siobhan O’Hagan, 29, has seen her weight go up and down as she cycled between dieting and training. But instead of bemoaning the weight fluctuation, she decided to make a much more optimistic point about the dangers of thinking that having cut, toned abs is synonymous with being happy.

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“I’ve been so many different shapes and sizes and I can tell you – abs are not the key to happiness,” O'Hagan captioned a post she put on Instagram on Monday, along with four images of her midsection over the years. “It’s down to having an attitude to training and nutrition that allows you to enjoy your life while feeling your best.”

O’Hagan admitted that previously, she celebrated losing “loads” of weight, and at other moments, she felt great while training for a bikini competition. Her happiness was the same no matter how her abs looked—an important point in a world where rock-hard abs are a beauty standard most of us can't achieve. 

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She also calls out the first photo, taken before she began dieting and strength training. “I just wasn’t enjoying my life or my training or anything (I think you can tell by my face),” she wrote. "It takes a lot of hard work and will power to change your body dramatically and now I’ve done it [and] I’m like meh I’m happy up here.’”

Her more intuitive approach to living is aspirational, and she is totally fine with not being “shredded.” 

Posing in a two-piece, she radiates body confidence.