Tag Archives: implant

FDA Warns Allergan Over Breast Implant Studies

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Sasha Chavkin, International Consortium of Investigative Journalists: May 19, 2020

United States health authorities issued a warning letter to leading global breast implant manufacturer Allergan for failing to properly carry out post-market safety studies.

The U.S. Food and Drug Administration found that Allergan did not meet its standards for recruiting and following up with participants in studies that included several styles of implants withdrawn from sale worldwide last year due to cancer risks.

Another company, Ideal Implant Incorporated, was rebuked for failing to properly track complaints by customers or take adequate corrective actions for problems identified during a site inspection.

“The FDA will continue to hold manufacturers accountable if they fail to fulfill their obligations,” Dr. Binita Ashar of the FDA’s Center for Devices and Radiological Health said in an agency statement announcing the warning letters.

In November 2018, the International Consortium of Investigative Journalists revealed that thousands of women around the world were suffering from serious illnesses after receiving breast implants, a finding that was part of its global Implant Files investigation.

In the months after the Implant Files’ publication, regulators around the world took action to better protect patients. Authorities in France, Canada, and the United States announced bans on Allergan Biocell implants, which were associated with increased risk of a rare form of cancer.

The moves prompted Allergan to announce a global recall of Biocell products last July. (Earlier this month, Allergan was acquired by global pharmaceutical giant AbbVie.)

The recalled implants are among the ones that Allergan was failing to properly study, the FDA found. The agency noted that the studies were crucial to identifying the risks for patients already implanted with Biocells.

“Post-approval studies are especially important to inform our understanding of the long-term potential risks associated with Allergan’s implants, including the models that have since been recalled from the market,” Ashar said in the FDA’s statement.

The agency touted the warning letters as a part of its “ongoing efforts” to better protect breast implant patients, also citing its Medical Device Safety Action Plan and the development of a National Breast Implant Registry to collect data on breast implant safety.

But Dr. Diana Zuckerman, the director of the National Center for Health Research, a health policy think tank, said the agency must also be willing to take tough measures against companies that fail to follow its rules.

Zuckerman noted that breast implant makers have a history of poor compliance with safety studies mandated by the FDA, which approved silicone breast implants for the U.S. market in 2006 despite scant data on their long-term safety.

Instead, the agency allowed manufacturers Allergan and Mentor to conduct long-term safety studies after their products were already on the market. Within three years, Allergan and Mentor lost touch with 40% and 80% of the patients, respectively, in key sections of these post-approval studies, torpedoing the FDA’s demand that they collect reliable long-term data.

Nonetheless, the agency permitted the implants to remain on the market.

Zuckerman was skeptical that the warning letters would have much effect unless the FDA showed it was willing to take products that violated its rules for safety studies off the market.

“It absolutely should be possible to take off the ones that aren’t studied properly,” Zuckerman said. “I guarantee if they did that the ones that are still on the market would finish their studies.”

Read the full article here. 

Former Playmate of the Year on Removing Breast Implants: ‘I Literally Thought I Was Dying’

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Kris Pickel, AZ Family: May 4, 2017.
Karen McDougal
Karen McDougal

It wasn’t a decision Karen McDougal took lightly.

As a former Playboy Playmate of the Year, her career is built on beauty and fitness, but McDougal says her health deteriorated to the point she felt like she was going to die.

In January, McDougal made the decision to explant & have her breast implants removed.

McDougal says she battled health problems – issues she now believes stemmed from her implants — for more than a decade. Her health issues began eight years after she got her implants.  McDougal said she would get sick for six to eight weeks at a time, get better for a month or two and then get sick again.

It became a running joke among McDougal’s family and friends that she was the “healthiest sick person.”

For a decade, doctors failed to diagnose the cause of her sickness.  She said one doctor told her she was suffering from depression. Another told her that her implants looked great there was no need to replace them. […]

I talked to Dr. Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C. She has a long history on breast implant safety.

“From 1983 to 1993, Dr. Zuckerman worked as a Congressional staffer in the U.S. Congress, working for the House subcommittee that has oversight jurisdiction over the U.S. Department of Health and Human Services, including the FDA,” according to her biography on BreastImplantInfo.org. “She was responsible for more than a dozen Congressional investigations and hearings on a wide range of health issues, including the first Congressional hearings on breast implants. It was Dr. Zuckerman’s congressional investigation of breast implants that first raised questions about the lack of safety data, which led to the FDA requiring safety studies of silicone gel implants in 1991. When the companies did not provide evidence that implants are safe, the FDA restricted their availability in 1992.”

Zuckerman said many studies over the years have been funded by organizations representing plastic surgeons and implant makers, all of which have a financial interest in making implants look safe.

She says the companies and organizations sometimes help shape studies with results that are not scientifically valid.

Zuckerman also said some studies might have been manipulated in a number of ways.

“I’ve spoken with some of the women in some of the studies who said as soon as they started complaining to their plastic surgeon about how sick they were feeling, suddenly they stopped hearing from the plastic surgeon about coming in to continue the study,” she said. “Suddenly, they weren’t in the study anymore. One very effective way to have studies proving that a product is safe is to just get rid of the patients in the study who aren’t feeling well — just stop talking to them and stop asking them how they are.”

Zuckerman said there are additional problems with some studies, including basing data on hospital records when most symptoms of chronic illnesses, such as fatigue and hair loss, do not require hospital stays. Also, many studies are done over short periods of time, between two and five years after the implant surgery, when illness may not start showing until several years later.

Zuckerman says if a woman decides to have her implants removed, there is a specific procedure. The implants must be removed with the scar tissue that forms around each implant, the capsule, still in place.

Read the original article here.

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

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Chloe Tejada, The Huffington Post Canada: July 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. 

Silicone Implants Backed by FDA Panel

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Marc Kaufman, Washington Post: April 14, 2005.

A Food and Drug Administration advisory panel recommended yesterday that silicone gel breast implants made by Mentor Corp. be allowed back on the market for wider use — a surprise decision that came a day after the same panel rejected the application of a rival company.

Mentor officials were delighted by the panel vote.

In explaining their decision, several panel members said they were more impressed by Mentor’s data on how and why implants rupture and by the lower rupture rate of its implants. While Inamed reported a yearly ruptue rate of about 1.4 percent, the yearly Mentor rate was 0.2 percent — a figure that had been questioned by FDA reviewers.

The panel decision was sharply questioned by Inamed officials, who had been criticized the day before for not having sufficiently long-term data.

“Inamed views today’s panel decision as curious and inconsistent with the decision reached by the panel yesterday on Inamed’s [application] — we look forward to working with Dr. [Lester M.] Crawford and FDA staff on addressing these inconsistencies,” Inamed president and chief executive Nicholas L. Teti said in a statement.

About 260,000 American women had their breasts enlarged with implants last year, and an additional 60,000 had received them after surgery for breast cancer.

Because of health concerns, the FDA in recent years has allowed silicone gel implants to be used only in women who had mastectomies and in some who take part in clinical trials; all others received implants filled with a saline solution. Many women say the silicone gel looks and feels more natural, and it is widely used in other parts of the world.

The panel’s decision was also criticized by some public interest groups, which have long argued that the potential dangers of silicone gel implants remain insufficiently studied.

“I think this was a triumph of wishful thinking which overruled the lack of science,” said Diana Zuckerman, president of the National Center for Policy Research for Women and Families. “Because of all the conditions, it’s far from a done deal regarding the FDA. It’s not helpful to women to have a product approved on the basis of two years of safety data.”

[…]

Read the original article here.