Tag Archives: Implants

How the FDA Handles Recalls of Life-Saving Implants Could Put People at Risk, Patients Say

Nicole Carr, WSBTV; May 20, 2019



Jonesboro resident Geraldine Robinson is one of millions of Americans who use an implanted medical device to improve, and possibly extend her life.

In 2013 she was implanted with a defibrillator to help with her congestive heart failure. She went to the doctor for checkups every six months. Robinson thought her device would keep her healthy for years. But last month the hospital called to tell her that device’s battery was failing. Robinson rushed to the emergency room.

“I was scared they wasn’t going to get to me in time,” Geraldine said.

The next day doctors replaced her device. The reason for the surgery noted on her patient information card was, recall.

Channel 2’s Nicole Carr searched the FDA recall database and found Robinson’s device had been recalled two years earlier. The manufacturer’s suggested course of action was to monitor the device.

While Robinson said she had no idea her device was recalled, her hospital said she was mailed a letter to notify her. Robinson said she never got that letter.

Diana Zuckerman, president of The National Center for Health Research, said she wasn’t surprised that Robinson’s recalled device remained implanted for years.

“This is the doctor having to say to the patient, ‘This implant in your body has been recalled but we don’t think you should have it removed unless you’re having obvious problems with it,” Zuckerman said.

Zuckerman was also said Robinson is most likely not alone in her confusion, and often patients don’t learn their device is recalled.

“Perhaps the patient has moved and the doctor or even the hospital doesn’t know where that patient is anymore,” Zuckerman said.

Linda Radach, an implant recipient herself, said she believes the recall process needs an overhaul.

“The FDA is very, very slow to use their authority to issue a recall instead requiring warning letters and requiring post market surveillance studies. Most of which are never completed,” Radach said.

According the FDA website they hardly every issue a recall, instead trusting manufacturers to self-report. An FDA spokeswoman said recalls are not the only way they get dangerous products off the market.

There are several patient resources available for medical device recipients, including questions to ask your doctor about the approval process.

Radach said a 2006 metal on metal hip replacement failed leaving dangerous cobalt chromium debris in her system.

“I’ve now had six total hip replacements,” Radach said. She said her issues were never reported to the FDA by her doctors and her device was never recalled. She did her own research and found her device had been approved for market three years after it was put in her body. “That alarmed me enough to realize this was much, much bigger than just me.”

Radach told Channel 2 Action News many of the parts that made up her implant were cleared through the 510k process which rarely requires clinical trials on human patients. The process has been in place since 1976.

Zuckerman said the 501K process it’s not enough.

“All those companies have to do is prove that their new device is substantially equivalent to a device that’s already on the market,” Zuckerman said.

In 2011 Zuckerman co-authored a report that found from 2005 until 2009, 113 recalls were class one. Only 21 of those recalls went through clinical trials. She said things haven’t improved.

“Instead of saying ‘let’s be more stringent and require clinical trials for more implants,’ they’re doing exactly the opposite,” Zuckerman said. […]

See the original story 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.

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

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.”

Read the original article here.

FDA explores possible link between breast implants, cancer

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. […]

Read the original article here.

Some Hidden Choices in Breast Reconstruction

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’

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.” […]

Read the original article here

FDA Ends Ban on Silicone Implants

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. […]

Read the original article here.

Implants, Mastectomies Linked to Problems

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. […]

Read the original article here

FDA Panel Backs Breast Implants From One Maker

Gardiner Harris, The New York Times: April 14, 2005.

Silicone breast implants made by a California company should be available to women who undergo cosmetic breast surgery, a federal advisory panel voted on Wednesday, rejecting arguments about serious health problems.

The panel chairman called the 7-to-2 vote to approve an application by the company, the Mentor Corporation, unexpected.

On Tuesday, the panel voted, 5 to 4, to reject a similar application from the Inamed Corporation. […]

The three-day hearing on implants began on Monday and included more than 160 witnesses who gave impassioned pleas to approve or reject silicone implants.

Dozens of women said implants had sickened them severely, and some gave gruesome testimony about silicone from ruptured implants squeezing out of their eyes and ears. […]

At the moment, just saline implants are allowed for purely cosmetic operations, even though many patients and doctors say silicone implants feel more natural and look better. Several panel members said they had voted to approved the implants because Mentor made a more convincing presentation than Inamed. […]

Inamed and women’s groups complained about the votes.

“I’m stunned and amazed by a bizarre and strange decision by a few panel members who yesterday demanded longer-term safety data and today accepted shorter-term data,” a vice president of Inamed, Dan Cohen, said.

Dr. Diana Zuckerman, president of the National Research Center for Health Research, called the conflicting votes illogical and predicted that the drug agency would reject both applications.

[…]

Read the original article here.

More Teens See Implants As a Right

Jodi Mailander Farrell, Knight Ridder Newspapers: December 07, 2004.

Melissa Gonzalez knew her family intended to give her enough money to buy a new car when she turned 18. But she had her heart set on something else: Bigger breasts. […]

Gonzalez is not alone. In just one year, the number of girls 18 and younger getting breast implants jumped nearly threefold — from 3,872 in 2002 to 11,326 in 2003, the American Society for Aesthetic Plastic Surgery reports. […]

Dr. Jose M. Soler-Baillo, a South Miami plastic surgeon who performed Gonzalez’s augmentation, says getting implants has become a ”coming-of-age type of thing” for many young women, “especially here in Miami.” […]

Critics say the timing couldn’t be worse for adolescent girls, who are often unhappy with their looks. They say teenagers are too young and shortsighted to comprehend the long-term affects of surgery, particularly the risks, which include the possibility of rupture or permanent scarring, the need for periodic operations to replace or remove the implants and the potential problems with breast-feeding and mammography. Also, little is known about the implants’ long-term safety; no studies have been done on females this young.

”It might feel to a 17-year-old like it’s the end of the world to wait a few years, but their bodies are still changing,” says Diana Zuckerman, president of the National Research Center for Women & Families. ‘Those breasts are likely to get larger, especially when they go off to school and gain the `freshman 15,’ the pounds girls often put on between ages 18 and 21. Their whole body begins to look more voluptuous.” […]

There is no law forbidding implants in patients younger than 18, but the FDA advises against it. In the past 15 years, implants have been the subject of furious controversy over their safety. The FDA has banned silicone-gel implants because of unanswered questions about their safety, but it permits the use of saline-filled implants, which have a silicone shell. Both types are the subject of ongoing FDA studies.

Zuckerman, the mother of two teenagers, says girls should wait until they are 21 to consider breast surgery. […]

Read the original article here.