Category Archives: Helpful Articles

How to Report Problems With Medical Products to the FDA

Every year, tens of thousands of consumers suspect that their medicines or medical devices might be causing unexpected side effects. Side effects – also called adverse reactions – can be quite minor, such as a rash or stomach upset, or very serious, such as mental confusion, heart damage or an autoimmune reaction. It is sometimes difficult to tell if the health problem is caused by the medical product or is merely a coincidence. That is why serious problems that are possibly related to a medical product should be reported to your physician and to the Food and Drug Administration (FDA). You do not have to be certain that the health problem is caused by the medical product – the purpose of a tracking program is to figure out if there is a problem by looking for a pattern in the reports. By tracking these reports, the FDA can determine if there is a pattern that may indicate the need to warn consumers or even to withdraw a product from the market.

The FDA has a program called MedWatch for reporting serious reactions and problems with medical products, including drugs and implanted devices.

The process is relatively simple and is outlined on the MedWatch website. You may ask your doctor to fill out a MedWatch form detailing the problem you have been experiencing. The MedWatch form is available online or you or your doctor can request a copy of the form by calling the FDA toll free at 1-888-INFO-FDA (1-888-463-6332).

If for some reason you do not wish to have the form filled out by your doctor or your doctor refuses to fill out the form (doctors are not required by law to complete a report to the FDA), then you can complete the form yourself. MedWatch provides a set of instructions for completing the form on their website, as well as an online form that you can submit on the website.

If you prefer to report your problem over the telephone, you can do that by calling the at 1-800-FDA-1088.

If you have questions or comments about a specific drug or medical device, you can call the FDA toll free information number at 1-888-INFO-FDA (1-888-463-6332), press 2, followed by 1 for information, then:

  • for dietary supplements, press 2
  • for drug products, press 3
  • for medical devices, press 4
  • for biologics, including human cells, tissues and cellular and tissue-based products, press 6

Reporting problems helps fix them and ensure that other patients do not experience the same unexpected side effects or reactions.

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

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

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

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.

Breast Implants Causing Cancer

WJMN Local 3 News: September 8, 2017

Stacey Boone says she was trying to boost her self-esteem, and wound up fighting for her life.

Boone says, “It was, how I wanted to feel about myself.”

She had no idea hew new beast implants would nearly kill her.

Boone says, “I came close three different times to dying. It started metastasizing to my bones and it metastasized to my liver, my liver had shut down.”

Stacey says doctors determined the plastic from her textured implant caused breast implant-associated lymphoma. The symptoms include lumps or hardening of the implant and fluid behind the implant.

Dr. Frederick Locke, medical oncologist, Moffitt Cancer Center says, “The symptoms often come on years after the breast implants are surgically placed.”

Dr. Locke says recent FDA warnings show there have been 359 breast implant-associated lymphoma cases reported. Nine deaths have been documented.

Dr. Locke says, “When the FDA looked at whether it was associated with silicone or saline implants there wasn’t much of a difference.”

But the difference in these cases? 90% had textured implants, just like Boone. Locke says breast implant-associated lymphoma can affect 1-in-30,000 women. […]

Read the original article here.

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

CBS NewsJuly 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.

A Shocking Diagnosis: Breast Implants “Gave Me Cancer”

Denise Grady, New York Times: May 14, 2017

Raylene Hollrah was 33, with a young daughter, when she learned she had breast cancer. She made a difficult decision, one she hoped would save her life: She had her breasts removed, underwent grueling chemotherapy and then had reconstructive surgery.

In 2013, six years after her first diagnosis, cancer struck again — not breast cancer, but a rare malignancy of the immune system — caused by the implants used to rebuild her chest. […]

Her disease — breast implant-associated anaplastic large-cell lymphoma — is a mysterious cancer that has affected a tiny proportion of the more than 10 million women worldwide who have received implants.  […]

The Food and Drug Administration first reported a link between implants and the disease in 2011, and information was added to the products’ labeling […] An F.D.A. update in March that linked nine deaths to the implants has helped raise awareness. The agency had received 359 reports of implant-associated lymphoma from around the world, although the actual tally of cases is unknown because the F.D.A.’s monitoring system relies on voluntary reports from doctors or patients. The number is expected to rise as more doctors and pathologists recognize the connection between the implants and the disease. […]

As late as 2015, only about 30 percent of plastic surgeons were routinely discussing the cancer with patients, according to Dr. Mark W. Clemens II, a plastic surgeon and an expert on the disease at the University of Texas MD Anderson Cancer Center in Houston. […]

Diagnosis and Treatment

Most of the cancers have developed from two to 28 years after implant surgery, with a median of eight. A vast majority occurred with textured implants. […]

Researchers estimate that in Europe and the United States, one in 30,000 women with textured implants will develop the disease. But in Australia the estimate is higher: one in 10,000 to one in 1,000. No one knows why there is such a discrepancy. […]

Symptoms of the lymphoma usually include painful swelling and fluid buildup around the implant. Sometimes there are lumps in the breast or armpit. […]

What exactly causes the disease is not known. One theory is that bacteria may cling to textured implants and form a coating called a biofilm that stirs up the immune system and causes persistent inflammation, which may eventually lead to lymphoma. The idea is medically plausible, because other types of lymphoma stem from certain chronic infections. Professional societies for plastic surgeons recommend special techniques to avoid contamination in the operating room when implants are inserted […]

Read the original article here.

After Mastectomies, an Unexpected Blow: Numb New Breasts

Roni Caryn Rabin, The New York Times: January 29, 2017

After learning she had a high genetic risk for breast cancer, Dane’e McCree, like a growing number of women, decided to have her breasts removed. Her doctor assured her that reconstructive surgery would spare her nipples and leave her with natural-looking breasts.

It did. But while Ms. McCree’s rebuilt chest may resemble natural breasts, it is now completely numb. Her nipples lack any feeling. She cannot sense the slightest touch of her breasts, perceive warmth or cold, feel an itch if she has a rash or pain if she bangs into a door.

And no one warned her.

“I can’t even feel it when my kids hug me,” said Ms. McCree, 31, a store manager in Grand Junction, Colo., who is raising two daughters on her own.

Plastic surgeons performed more than 106,000 breast reconstructions in 2015, up 35 percent from 2000. And they have embraced cutting-edge techniques to improve the appearance of reconstructed breasts and give them a more natural “look and feel” — using a woman’s belly fat to create the new breast, sparing the nipple, minimizing scarring with creative incisions and offering enhancements like larger, firmer lifted breasts.

Read the original article here.

Crystal Hefner Shares The Health Problems Breast Implants Can Pose

Bruce Y. Lee, Forbes: July 24, 2016

Crystal Hefner, formerly Crystal Harris and the 30-year-old Playboy model and wife of Playboy founder Hugh Hefner, announced the recent removal of her breast implants by […] sharing a post on Facebook that began, “My Breast Implants Slowly Poisoned Me.” She rattles off a litany of health problems that she says she suffered from the implants such as:

  • Intolerance to foods and beverages
  • Unexplained back pain
  • Constant neck and shoulder pain
  • Cognitive dysfunction (brain fog, memory loss)
  • Stunted hair growth
  • Incapacitating fatigue
  • Burning bladder pain
  • Low immunity
  • Recurring infections
  • Problems with thyroid and adrenals
  • Days  when she couldn’t get out of bed

She explains that at first she was diagnosed with Lyme disease and toxic mold, but then learned via social media that her symptoms resembled “breast implant illness.”

After visiting a breast implant illness website and Facebook group with almost 3,000 members, she realized that her symptoms matched. On June 15th, 2016, plastic surgeon Dr Lu-Jean Feng removed Hefner’s breast implants. […] Her Facebook post continues: ”Instantly I noticed my neck and shoulder pain was gone and I could breathe much better. I know I won’t feel 100% overnight. My implants took 8 years to make me this sick, so I know it will take time to feel better. I also have other illnesses to address, but with the toxic bags removed, my immune system can focus on what it needs to.” […]

Read the original article here. 

Crystal Hefner Removes Breast Implants, Says They ‘Slowly Poisoned’ Her

Chloe Tejada, The Huffington Post CanadaJuly 21, 2016

[…]On Tuesday, Crystal Hefner posted an update to her social media accounts, revealing to her fans that she removed her breast implants after they caused several major health problems and bad side effects. […]

“My Breast Implants Slowly Poisoned Me,” she titled her post. “Intolerance to foods and beverages, unexplained back pain, constant neck and shoulder pain, cognitive dysfunction (brain fog, memory loss), stunted hair growth, incapacitating fatigue, burning bladder pain, low immunity, recurring infections and problems with my thyroid and adrenals,” she wrote. Hefner went on to explain that symptoms started a few years ago but she ignored them, despite the fact that she was not feeling well.

“The aches, the bladder pain, brain fog, fatigue. I ignored it, labeling myself a hypochondriac, despite truly worrying that there was something wrong with me. I joked about losing my memory to age, and about getting ‘lazy.'”

As the negative side effects worsened, her work as a model and DJ suffered […]

After announcing that she had been diagnosed with Lyme Disease and toxic mold, commenters said her symptoms were similar to the effects of those suffering from Breast Implant Illness.

She became a patient at The Lu-Jean Feng Clinic in Ohio, where, after discussing it with Dr. Lu-Jean Feng, she had her implants removed.

“Instantly I noticed my neck and shoulder pain was gone and I could breathe much better,” she wrote about how she felt after the surgery. “I know I won’t feel 100% overnight. My implants took 8 years to make me this sick, so I know it will take time to feel better. I also have other illnesses to address, but with the toxic bags removed, my immune system can focus on what it needs to.” […]

Here’s to wishing Crystal a safe, and healthy recovery.

Read the original article here. 

Stephanie March Opens Up About Breast Augmentation Health Scare

Katie Kindelan, ABC News: June 30, 2016

Actress Stephanie March, best known for playing an assistant district attorney on “Law & Order: SVU,” has opened up about a dangerous reaction she experienced after undergoing breast augmentation.

March, 41, described the episode in a candid essay she wrote for Refinery29. The actress said she decided to have the surgery during a painful time in her life — her split from her then-husband, chef Bobby Flay. […]

March wrote that just two months after the surgery she experienced complications and learned her right implant was infected and the seams of her scar on her right side had burst. Her surgeon removed the implant and sent her to an infectious disease doctor.

“I [had] a hole in my breast for 6 weeks while I blasted my body with antibiotics. I had the implant put back in. I had another infection and rupture on Christmas Eve. I had it taken out again. I had more cultures and tests and conversations with doctors than I care to recall,” March wrote.

March said she came to the conclusion that her complication was not something anyone could have prevented but that, “I am allergic to implants. Plain and simple. My body did. Not. Want. Them. I kept trying to ‘fix’ my body, and it kept telling me to leave it alone.”

The actress, whose divorce from Flay was finalized in July 2015, ultimately had her implants removed. […]

March told ABC News in a statement she is “overwhelmed” and “very moved” by the “positive reaction” to her article.

Dr. Jennifer Ashton, ABC News Chief women’s health correspondent, said today on “Good Morning America” that even common plastic surgery procedures like breast augmentation are “not without complications.”

“You need to know about these possible complications and they do differ based on the type of implant used, the approach used, the incision and generally the skill and the expertise of the surgeon, although these can happen with the best surgical technique,” Ashton said, adding that March noted in her Refinery29 article she did not blame her own surgeon.

Ashton recommends that patients ask their doctor the following three questions before undergoing plastic surgery: Are you board-certified in plastic surgery? How many of these operations you do per year? What is your complication rate?

“If you think that having cosmetic surgery is going to change your life, it’s not,” Ashton added. “And there’s no such thing as minor surgery. You get a complication, it becomes major real fast.”

Read the original article here.