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Sientra’s Silimed Brand “Gummy Bear” Silicone Gel Breast Implants Pose Safety Questions

gummy-bear-bubblegumMingxin Chen, MHS and Diana Zuckerman, PhD, The National Center for Health Research

In December 2012, the U.S. Food and Drug Administration (FDA) approved Sientra’s for its “Silimed silicone gel breast implants.” These implants are also called “gummy breast implants” because they are made of a thicker gel that is said to resemble candy gummy bears.

To gain approval, the company was required to submit the results of a clinical trial to prove that the implants were safe and effective. A 5-year study of these implants was published in the November 2012 issue of Plastic and Reconstructive Surgery, authored by three Sientra employees and several plastic surgeons who were paid by Sientra to conduct the research.1 The study included 1,788 participants with 3,506 breast implants.

Re-operation, Rupture, and Capsular Contracture

The three major complications measured were need for a re-operation, rupture, and capsular contracture. They can occur at any time, and become more common as the implants age. Capsular contracture refers to the formation of scar tissues around breast implants which becomes hard and potentially painful as the patients’ immune system reacts to the implant. MRIs were conducted on 571 of the 1788 participants to assess rupture that has no obvious symptoms.

The study indicated that the overall risk of rupture during the five years of the study was 2%, but that is misleading because the rupture rate was higher when “silent ruptures” measured by MRI were counted. MRI is the most accurate way to determine if an implant is ruptured, and more than 4% of first-time augmentation patients had a rupture within 5 years, which is much higher than expected. The risk of capsular contracture was 9% overall, and did not vary much for the different types of patients.

In contrast, the risk of reoperation varied considerably: 43% for first time reconstruction patients, 48% for reconstruction revision patients, compared to 17% for first time augmentation patients and 30% for augmentation revision patients. Revision patients are those whose previous implants were replaced with the Sientra implants.

Other Complications

There were many other complications affecting appearance and health. Most complications are highest for patients whose implants are for reconstruction after mastectomy; for example, 11% have asymmetry, 5% have an infection; 4% have breast pain, 4% of the implants are not in the correct position, and 3% have abnormal scarring. Complications are even higher for reconstruction patients who had earlier implants replaced by Sientra implants: 15% have breast asymmetry, 7% have implants in the wrong place, 5% have breast lumps or cysts, and 4% have breast pain.

For first-time augmentation patients, 3% have nipple sensation changes (either losing sensation or painfully sensitive) and 3% have sagging breasts. As noted earlier, reoperation, capsular contracture, and rupture are more common. Other complications, such as pain and swelling, add up, but each of these others complication is below 3%. Among revision augmentation patients, 5% have implants in the wrong position, 3% develop sagging breasts, 3% have wrinkling around the implant, and 3% have breasts that look asymmetrical.

Despite these high level of complications within only five years was high, the authors defended the implants. For example, they stated that over half of the patients who removed or replaced their implants did so for cosmetic reasons, predominantly patient request for style/size change. Regardless of the reason however, additional surgery is expensive and puts the patient at risk. And for breast cancer patients who chose mastectomy and implants so they would not have to think about cancer, these surgeries are a very unwelcome reminder.

The authors claimed Silimed is superior to the other two implant brands, Allergan and Mentor, in terms of risk of complications, as its risk of capsular contracture among first-time and revision augmentation patients within 5 years is 9% and 8%, in comparison with Allergan’s 13% and 17%, and Mentor’s 9% and 20%, both within 4 years.

Sientra, based in Santa Barbara, California, is the third largest global manufacturer of silicone implantable devices. The approval of the first gummy bear implants was welcomed by plastic surgeons, who pointed out that these implants had been manufactured and distributed outside of North America for 15 years.  However, the FDA approved the implants based on only 3 years of data, rather than the longer studies that would have been possible since the implants were on the market for 15 years.

Dollie Voyles

image1My name is Dollie Voyles and I am 48 years old. I’ve had  3 sets of breast implants over the past 21 years, starting in 1995.

I later learned that my plastic surgeon was originally an Ears, Nose, and Throat doctor . When I arrived at his office I was given a form to fill out for my basic health information. I went back to meet the doctor and he told me I would be in pain for a while and wouldn’t be able to move or lift my arms. That is all he told me about any possible risks .

I had smooth saline implants put under the muscle.  Initially, everything seemed fine. However, less than three years later, my right breast implant ruptured. I woke up flat . I called my plastic surgeon frantic and he said it’s ok because it’s just salty water. He had me come back for surgery 2 weeks later . I asked him why and how this happened. He  said he’s never had this happen in his practice and I believed him.

My second set of breast implants, which replaced the ruptured ones, were  textured saline implants . My plastic surgeon said he’s using this style because he thought my body didn’t take to the last kind, and by putting in textured saline it would have something to grab on to. I trusted him. He never talked about risks at this meeting either. Over the next 7 years they became  so misshapen and physically unappealing that I was so embarrassed and felt so self-conscious.

I decided I needed to change doctors and get a new opinion so I went to a more experienced doctor. This doc seemed very confident and I wasn’t going to let him do anything to my body until I get some answers. This plastic surgeon said I needed silicone gel implants instead. He said they feel more real and they don’t change shape. I was immediately conflicted because I did hear somewhere where silicone was bad for your body. He assured me that the gummy bear silicone that he’s going to use  was the best thing for me, especially with all the FDA approvals! I asked him about ruptures and he said if they did it’s just like a gummy bear, it will stay in place. He said they hold their form. I thought well, he’s the professional. Again , I wasn’t given any information about implants and definitely I wasn’t given information about silicone implants .

For over 6 years these ” safe silicone gummy bear implants – FDA approved ”  changed shape and became  painful to touch.  And they burned. I was diagnosed with severe allergies,autoimmune reactions that caused pain in my joints and legs , itchy breasts, shooting pain in my breasts, headaches, anxiety,depression, brain fog and finally fatigue. In 2012 , three years after my silicone breast implants, I suffered a stroke. I was told that the reason for my stroke was that I have low potassium and I’m anemic. These findings was startling since I was completely healthy prior to my last set of implants .

With all my pain in my breast and how crappy I was feeling I finally had an MRI and its showed that I had intracapsular rupture in my right breast. I knew something was wrong. When my explant doc opened me up my breast gushed of silicone and apparently he had to scoop silicone off my chest wall. This was nothing like a gummy bear that keeps its shape.

And it wasn’t until a few weeks ago that I learned that gummy bear implants were not FDA-approved in the U.S. in 2009!  Was I in a clinical trial that my doctor never told me about?  I certainly never gave my doctor permission to put experimental implants in my body.

Why are celebrities removing their breast implants?

Amelia Murphy

Celebrities who removed their breast implants

Every now and then, a new celebrity is in the news after announcing her decision to remove her breast implants. They speak out about the importance of loving yourself the way you are, they post some Instagram pictures of “the new me,” and the public eagerly reads the related articles in tabloid magazines.

But most of these women aren’t just talking about body image; they are getting their implants removed because of their health. Breast implants can make some women so sick that removal is their best hope for feeling like themselves again.  Several celebrities are trying to spread this information to the general public.

crystal_hefner_2014Crystal Hefner, Hugh Hefner’s wife, opened up about her breast implant horror story on Facebook. She announced her implants had been slowly poisoning her and causing unexplained back pain, cognitive problems, constant neck and shoulder pain, recurring infections, and many other symptoms. Once she removed her breast implants, she instantly felt an improvement and continues to feel better. [Read more about her story in this Forbes article]

Yolanda Foster, of Real Housewives fame, removed her breast implants when she found out her silicone implants had ruptured and were leaking into her body. The silicone was making the symptoms of her Lyme disease even worse. She felt much better once she removed her implants.

Linda Blair, actress in the horror movie The Exorcist, described her experience with breast implants as a nightmare. After removing her implants, she advocated for the FDA to make sure breast implants are actually studied to be safe.

Mary McDonough, a child star in The Waltons who appeared as an adult in shows such as ER and Will and Grace, attributes her autoimmune disease (lupus) to her breast implants. She was healthy before getting implants, and it was only after her implants were removed that she immediately started to feel better. She has been one of the most outspoken celebrities on the risks of breast implants.

Mariel Hemingway, Sharon Osbourne, and Stevie Nicks are just a few of the other celebrities who chose to remove their breast implants because of serious health problems.

Celebrities are bringing attention to the health problems that thousands of women with implants have suffered from for decades.

First, a little history:

Women have been getting breast implants since the 1960’s, and although silicone gel implants were drastically restricted for many years during the mid-1990’s through 2005 because of safety concerns, the FDA approved them again in 2006 based on short-term studies done by breast implant manufacturers. FDA also required the manufacturers to do larger, longer-term studies after that, in order to make sure they were safe (these are called post-market studies).

These longer-term studies had a lot of problems, and most women did not stay in the studies long enough to provide useful scientific information.  However, studies have shown that the longer women have silicone breast implants, the more likely they are to experience problems with them.  FDA reported that the studies found that as many as 1 out of every 5 women who get silicone breast implants for cosmetic reasons need to remove their implants within 10 years.[1] This number rises to 1 out of every 2 women if they got reconstruction after a mastectomy.[1]  Were the women who dropped out of the studies the ones that were more likely to have health problems, or less likely?  You can read more about the unanswered questions from these studies here.

Breast implants were approved by the FDA even though research showed that between 15% and 20% of first-time augmentation patients will need additional surgery to fix implant problems within 3 years, whether the implants are filled with silicone gel or saline. [2][3] The chances of needing additional surgery increases as time goes on — 28% of women are on the second set of implants after 3 years, and this number doubles when the women have their implants for 6 years. The percentage is even higher than that for mastectomy patients whose implants were for reconstruction.

Are Your Breast Implants Making You Sick- (2)What usually goes wrong?

  • Rupture: All breast implants will eventually break, sometimes within a few months or years, and usually within 10 years.
  • Capsular Contracture: This is when the breasts get firm, then hard, and they can be very painful. Breast implants are a “foreign body” and the natural response for most women is that their body forms scar tissue around the implant, inside their body, to protect their body from this “foreign invader.”  This is a natural process. However, it’s called capsular contracture when the scar tissue tightens or hardens around the implants and causes abnormal firmness, hardness, or pain.
  • Pain: Besides pain caused from capsular contracture (see above), breast implants can cause back, neck, and shoulder pain because of their weight. Leaking silicone gel can also cause a painful burning sensation.
  • Anaplastic Large Cell Lymphoma (ALCL): This is a rare kind of cancer of the immune system that is more likely to occur in women with breast implants. [4] If diagnosed early, removing the implants can cure the disease.
  • Autoimmune issues:  Experts disagree on whether breast implants cause specific autoimmune diseases.  However, the fact that implants can cause cancer of the immune system (ALCL) certainly makes it more likely that implants can cause other autoimmune problems.  FDA scientists found that women with ruptured and leaking silicone gel breast implants were more likely to have fibromyalgia, a painful autoimmune disease.[5]  Many women have reported suffering from autoimmune symptoms such as joint pain, hair loss, dry eyes, or mental confusion after getting breast implants, and have also reported that these symptoms often improve or disappear after removing the implants. One study even showed the autoimmune symptoms got better for 3 out of 4 women after they removed their implants.[6]
  • Constant flu-like symptoms: Many women report feeling constantly tired or like they’re trying to get over the flu.
  • Learn more about complications from breast implants in FDA’s consumer handbook.

Besides health problems, some celebrities decide to remove their implants simply because they were annoying or embarrassing. Just to name a few, Heather Morris, Heidi Montag, Pamela Anderson, Victoria Beckham, and Jane Fonda all removed their implants for this reason.

Plastic surgeons refer to breast augmentation as a very simple surgical procedure, and as a result many people think of breast implants as an insignificant surgery with few health risks.  Hearing about celebrities who removed their breast implants sometimes makes women think twice about getting them in the first place.  It helps remind all of us to do careful research before making any decision about putting something inside your body.

Are you considering breast implants? Find out more information here.

Are you thinking about removing your breast implants? Find out more information here.

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[1] FDA Update on the Safety of Silicone Gel-Filled Breast Implants. Center for Devices and Radiological Health U.S. Food and Drug Administration. Page 7. June 2011

[2] Important Information for Augmentation Patients About Mentor MemoryGel™ Silicone Gel-Filled Breast Implants, Mentor. (FDA Patient Brochure) November 2006. Pages 25-27. http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030053d.pdf

[3] Making An Informed Decision Saline-Filled Breast Implant Surgery, Inamed. 2004 Update. Pages 24, 32. http://www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm064457.pdf

[4] Miranda et al. Breast Implant–Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients. Journal of Clinical Oncology. Volume 32, Number 2. January 10 2014.

[5]  Brown SL, Pennello G, Berg WA, et al. Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women. J Rheumatology. 2001; 28:996-1003.

[6] de Boer M, Colaris M, van der Hulst RRWJ, Cohen Tervaert JW. Is explantation of silicone breast implants useful in patients with complaints? Immunologic Research. July 2016 DOI: 10.1007/s12026-016-8813-y\

Furor Over Drug Prices Puts Patient Advocacy Groups in Bind

By Katie Thomas, New York Times

September 27, 2016

Public anger over the cost of medical products has burned hot for a year, coursing through social media, popping up on the presidential campaign, and erupting in a series of congressional hearings, including one last week over the rising price of the allergy treatment EpiPen.

But one set of voices has been oddly muted — the nation’s biggest patient advocacy groups. The groups wield multimillion-dollar budgets and influence on Capitol Hill, but they have been largely absent in the public debate over pricing.

To those who have closely followed the drug world, the reason is simple: Many of the groups receive millions of dollars a year in donations from companies behind the drugs used by their members. When they prod drug companies, it is generally for better — not less expensive — treatments.

But critics say that by avoiding the debate over cost, they are failing in their patient-advocacy duties..

“It is a conflict of interest, because the interests of the pharmaceutical industry, from whom they are getting support, may be different from the interests of the patients,” said Dr. Michael Carome, the director of the Health Research Group at Public Citizen, a consumer advocacy group.

Over the last year, pharmaceutical companies have increased prices on medications as varied as breakthrough hepatitis C drugs and little-known generics that have been around for decades. The higher prices have hit American pocketbooks harder than usual, as insurers have increasingly shifted costs to patients.

And for patient groups, loudly addressing the issue can be perilous, as Cyndi Zagieboylo, the chief executive of the National Multiple Sclerosis Society, recently discovered.

She said members of her group, one of the most influential patient charities, had identified cost as a priority. The average annual cost for multiple sclerosis medications is $78,000 today, nearly 400 percent higher than the $16,000 average in 2004, the group says.

But as soon as Ms. Zagieboylo started discussing a plan — a modest proposal that involved bringing together drug makers, insurers and others to find solutions — she said she encountered resistance. Other patient groups would not join her, and she said she was told by members of Congress, as well as some of the pharmaceutical companies that donate to her group, to tread carefully.

“We were warned, you know, in a number of ways, just sort of to be careful about this,” Ms. Zagieboylo said. “A couple of pharmaceutical companies mentioned, ‘Boy, we support you, why are you doing this to us?’”

The group went ahead with the new campaign anyway, announcing it last week at an event attended by the National Health Council, an umbrella group for patient advocacy groups.

But Ms. Zagieboylo said the pushback gave her pause. She said she and the group’s board members decided they had to be ready to lose donors over the issue, including drug companies. The pharmaceutical industry donated about $10 million to the group in 2015, according to its website, accounting for about 4 percent of its annual budget.

“They are taking a lot of heat,” she said of the companies, who she said were not solely to blame for higher drug prices. “And they don’t want us to pile onto that, because they know we have influence.”

That influence is what makes patient groups so attractive to the drug industry. Some of the largest groups can call on millions of dedicated and highly motivated members and help drug companies by signing up participants for clinical trials, running financial assistance programs and even lobbying government officials for drug approvals or favorable legislation.

“It’s much more compelling when a parent reaches out to their congressman and says, ‘Please contact the F.D.A., because my child is dying,’” said Diana Zuckerman, the president of the National Center for Health Research, a nonprofit that does not accept money from industry.

But she said patient groups were less likely to take positions that might undermine a drug company’s business. “I’ve found almost none that are focused on the public health issues of affordable health care, affordable insurance, a sustainable system,” she said.

Some patient groups have directly challenged the industry. The American Diabetes Association, for example, this year called on drug companies to be more open about their prices and to allow the federal government to negotiate over Medicare drug pricing. The association said it received $26.7 million from the pharmaceutical industry in 2015, accounting for 14.5 percent of its budget.

But those actions have been the exceptions. And when patient groups have discussed pricing, their ire is largely focused on insurance companies, expressing arguments similar to those used by the pharmaceutical industry.

The Leukemia & Lymphoma Society, for instance, one of the largestcharities in the United States, has frequently criticized insurers for exposing patients to high out-of-pocket costs for patients, commissioning two studiesthat looked at the impact of these high costs. But it has not been as outspoken about the decision by drug companies to set those prices. Some blood cancer drugs that the society’s members need cost tens of thousands of dollars.

The group, which has an annual budget of about $300 million, spends millions of dollars a year funding research at universities and pharmaceutical companies that it hopes will lead to new treatments for blood cancers. According to its annual report, of the group’s 16 largest donors, eight were pharmaceutical companies. All eight donated more than $1 million to the society in 2015.

The group has been soliciting corporate sponsorships as well. On its website promoting sponsorships, aimed at drug and other companies, the society pointed to its “powerful footprint” of millions of constituents, and described itself as “an outstanding cause to build good will, positive public relations and marketing benefits that align with your brand and reputation.”

Last week, the society removed its corporate sponsorship page from its website, after The New York Times asked a spokeswoman about the language on the web page. She said the page was removed because the information was out of date.

Andrea Greif, a spokeswoman for the leukemia society, said the group considered access to drugs a key issue, and that it was meeting later this year with patients, insurers and manufacturers to address the problem.

She also said the group was “in the process of taking a fresh look at our position to ensure that we are living up to our role as the voice for all blood cancer patients.”

Part of the problem for the patient groups, many people said, is that there are no easy answers. Drug pricing is notoriously opaque and complex, involving a series of companies — such as pharmacy benefit managers like Express Scripts, drug distributors like Cardinal Health, or pharmacies like CVS or Walgreens — that can also profit from higher prices.

“We’re in an environment where all the stakeholders are blaming each other, and undermining each other, because of escalating costs,” said Marc Boutin, chief executive of the National Health Council, the organization that represents patient groups. Pharmaceutical companies accounted for 62 percent of the council’s $3.5 million budget in 2015, a spokeswoman said, and representatives from drug companies and an insurer sit on its board.

Representatives for the drug industry say the spotlight on pricing has obscured the headway companies have made in treating serious conditions.

“We are on the cusp of a new era of medicine,” said Robert Zirkelbach, a spokesman for the Pharmaceutical Research and Manufacturers of America, an industry lobbying group.

Yet patient groups may be increasingly pulled into the pricing debate whether they like it or not. Dr. James R. Baker Jr. and his group, Food Allergy Research & Education, got an uncomfortably close look at the shifting landscape several weeks ago, when they were criticized for taking money from Mylan, the company that makes the EpiPen.

This month, the group announced it would stop taking money from Mylan until there was meaningful competition in the market. Dr. Baker said about 6 percent of the group’s budget came from the pharmaceutical industry, but did not say how much came from Mylan, citing a confidentiality agreement with the company.

Part of the reason patient groups have not taken up the drug pricing issue, Dr. Baker said, is because for years, many of their members had insurance with low co-payments and deductibles, shielding them from the total cost of drugs.

“It was more of an issue of whether or not they could get the drug, and whether it was on the formulary, than what they were paying for it,” he said. “I think that is changing.”

Breast Implants In France To Carry Cancer Warning: Researchers Find A ‘Clearly Established Link’

By Dana Dovey, Medical Daily

March 18, 2015

Following France’s National Cancer Institute finding a “clearly established link” between breast implants and a specific type of cancer, the country will now order all breast implants to come with a cancer warning. This announcement came after 18 cases of anaplastic large cell lymphoma were directly linked to women with silicone breast implants since 2011.

Anaplastic large cell lymphoma (ALCL) is a type of non-Hodgkin’s lymphoma that affects the blood. The link between breast implants and this form of cancer is extremely rare, so French officials have urged women who already have the implants not to remove them, the Daily Mail reported. Given the severity of the cancer in the few women who do develop it, French officials felt it necessary to inform women of all the possible risks associated with the surgery.

ALCL is extremely rare, affecting around one to six in every three million women who undergo breast augmentation, Medical News Today reported. However, a study conducted by researchers from Cambridge University in the UK found that nearly all cases of ALCL in breasts occurred in patients who had undergone breast augmentation, suggesting a link between the two. Although it’s not clear why silicone breast implants can sometimes cause cancer, the Cambridge investigation did shed some light on the mystery.

“It’s becoming clear that implant-related ALCL is a distinct clinical entity in itself,” Dr. Suzanne Turner, lead researcher of the Cambridge study, told Medical News Today. “There are still unanswered questions and only by getting to the bottom of this very rare disease will we be able to find alternative ways to treat it.”

Breast implants are a very popular surgery, with Dr. Diana Zukerman, president of the National Center for Health Research, explaining that in 2013 alone 300,000 American women opted for the operation. Of these women, around 80 percent undergo breast enhancement for cosmetic reasons while a further 20 percent have breast implants following breast cancer.

This is far from the first time that breast implants have been implicated in causing a health hazard. In 2011, French firm PIP caused global hysteria when plastic surgeons reported an abnormal amount of the implants rupture, the Daily Mail reported. It was later found that the firm had been manufacturing these breast implants using industrial grade silicone intended for use in mattresses.

The implants were subsequently found faulty and banned from use. Women who had already received the implants were advised to have them removed, although European health officials found no medical or toxicological evidence to back this advice.

See original article here.