One undercurrent: Inadequacy of post-approval studies and spotty adverse event reporting, leading to incomplete data with which panelists could form opinions.

It was a busy year for FDA’s expert advisory committees, called on to tackle many of its biggest medical device questions in 2019, new and old.

[…]

Repeated meetings aren’t necessarily a negative, said Diana Zuckerman, president at the National Center for Health Research since 1999.

“We can’t think of these public meetings as a bad outcome … We wish that people weren’t being harmed by breast implants, by mesh, by Essure, and so on. But if they are being harmed, then I’d much rather there be a public meeting about it then to have it covered up,” Zuckerman said. “For breast implants especially, it’s made an enormous difference in terms of public awareness.”?

[…]

Read original story here.

Marilynn Marchione, Associated Press: September 14, 2018.

U.S. health regulators say they’ll convene a public meeting of medical advisers next year to discuss new science on breast implant safety, including an independent analysis that suggests certain rare health problems might be more common with silicone gel implants.

The Food and Drug Administration said it would hold the meeting even as its officials and several independent experts disputed the new work. Leaders of the study concede that it has big limitations and cannot prove that implants cause any of these problems.

Yet it involves nearly 100,000 women and is the largest long-term safety analysis of silicone implants since 2006, when they were allowed back on the U.S. market after a 14-year gap due to safety concerns.

“We completely stand behind this study and we do feel it’s our best data to date,” said lead researcher Dr. Mark Clemens, a plastic surgeon at the University of Texas MD Anderson Cancer Center. Women need as much information as possible to make an informed decision about whether and what kind of implant to get, he said.

The journal Annals of Surgery plans to publish the report on Monday. Study leaders have no current ties to implant makers although Clemens consulted for one in the past.

A POPULAR CHOICE

Each year in the U.S., about 400,000 women get an implant and most choose silicone over saline; surgeons say it can give a more natural look. Three-fourths are for women who want bigger breasts; the rest are for reconstruction after cancer surgery.

“Breast implants are not lifetime devices” and up to 20 percent of women getting them for enlargement need to have them removed within 8 to 10 years, the FDA’s website warns.

Complications can include infections, wrinkling, scarring, pain, swelling and implant rupture. Implant users also may have a very small but increased risk of a rare lymphoma, a type of cancer, the FDA has said.

But the agency decided there was not enough evidence to tie silicone implants to other problems such as immune system and connective tissue disorders, so it approved devices from two makers — Allergan and Mentor Corp. — in 2006. FDA required the companies to do more studies on how women fared, and the Texas researchers used these reports in an FDA database for their analysis.

WHAT THEY FOUND

Compared to women without implants, those with silicone implants seemed to have greater rates of an immune system disorder called Sjogren syndrome, a connective tissue disorder called scleroderma, and the skin cancer melanoma, although cases of these were rare, the researchers reported. But rates for other problems such as fibromyalgia were lower among implant users. Reproductive problems such as birth defects and stillbirths were mixed and inconsistent.

Furthermore, a higher rate of rheumatoid arthritis was tied to one brand but a lower rate for another. The difference gets to what critics called a fundamental flaw in the data used for the analysis: One implant maker required proof of diagnosis by a doctor rather than just a patient reporting a problem to include it in the database; the other did not.

Another study weakness is that more than half of women dropped out of touch within two years of their operations.

Because of these and other shortcomings, “we respectfully disagree” with the researchers’ conclusions and urge that they be viewed with caution, Dr. Binita Ashar of the FDA’s Center for Devices and Radiological Health said in a statement.

WHAT OTHERS SAY

“This study is messy” and has the potential to create more anxiety than insight, said Dr. Andrea Pusic, plastic surgery chief at Brigham and Women’s Hospital in Boston and president-elect of the Plastic Surgery Foundation, which supports research and advocacy by the American Society of Plastic Surgeons.

The group gets industry grants for some of its work, and Pusic gets royalties from a questionnaire used in many studies including this one.

Dr. Charles Thorne, plastic surgery chairman at Lenox Hill Hospital in New York and president elect of the American Society of Aesthetic Plastic Surgery, said the inconsistency in some of the results “is a little hard to explain” since the devices are similar chemically.

But the study is a worthy effort, he said.

“We have to constantly reevaluate the data and make sure things are safe,” Thorne said. “The best evidence we have now indicates there’s no increased likelihood of these systemic diseases.”

Read the original article here.

Daralene Jones, WFTV News: September 12, 2018.

CENTRAL FLORIDA – Local women are taking their fight against breast implants to the nation’s capital.

They first contacted 9 Investigates more than a year ago with claims their silicone gel-filled implants made them sick, and that they only got better once the implants were removed.

An FDA spokesperson confirms the closed-door meeting to 9 Investigates. The public and media were not allowed to attend.

The Central Florida women who attended the meeting said they want more transparency about the ingredients as well as better public awareness about risks that sometimes don’t show up for years.

They also want manufacturers to provide doctors with a checklist – that must be signed — warning women about illnesses some feel are only caused by implants and a rare cancer that’s already been linked to them.

“I’m still having trouble digesting food,” said Terri Diaz, who was one of 20 women who recently went to Washington to meet with the FDA.

Diaz is still trying to get her body back to a healthy state after she finally had her breast implants removed a year and eight months ago with a procedure commonly called, “ex-plant” surgery.

“That’s what we’re trying to do, hold the FDA accountable. They’re supposed to protect us,” Diaz said.

Last summer, 9 Investigates first reported about women blaming their implants for unexplained illnesses.

At the time, nearly 20,000 women were discussing the problem in a Facebook group. There are now more than 50,000 in that group.

Diaz also formed a Facebook group specifically for Florida women. It has the attention of nearly 2,000 implant patients.

Dr. Marguerite Barnett has a six-month waiting list for women who want their implants removed, and has expressed frustration with the FDA for not setting up a registry promised to track the implants.

“We have no idea of the failure rate, other than what the manufacturers choose to report,” Barnett said. It’s sad that we’re lacking all of this basic data.

The FDA granted pre-market approval to two breast implant manufacturers in 1996, expanding marketing of implants, but both companies were required to perform post studies to monitor safety and effectiveness.

Dr. Barnett says some of her patients never received proper follow-up care.

And although manufacturers do provide warnings about the health risks that can be associated with the class three medical devices, there are questions about whether patients are getting the message.

“So much of it is in technical terms, I think we really have failed to give really good informed consent,” Barnett said.

One of the implant manufactures told 9 Investigates in a statement they are partnering with groups to develop that breast implant registry — to better understand the cause the cause, incidence and potential risk factors associated with that rare form of cancer–no mention of other illnesses.

The FDA did not commit to any changes during the meeting, but told us 9 Investigates that they continue work to develop that registry.

The women in that meeting said they feel the FDA is strongly considering an Advisory Committee Panel meeting on breast implant issues.

Read the original article here.

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.