Dana Casciotti, Cancer Prevention and Treatment Fund, October 24, 2011

I am the public health research director of the Cancer Prevention and Treatment Fund, a nonprofit center that uses research findings to improve prevention and treatment strategies.  Our nonprofit does not accept money from pharmaceutical or device companies so I have no conflicts of interest.

My perspective today is as someone trained in public health at Johns Hopkins and previously worked at the National Cancer Institute.  I am very familiar with clinical trials and research methodology.

You have already discussed how poor the follow-up was on the implant studies.  I was disappointed that an FDA official implied yesterday that most of the post-market studies were fine, and only a few were not.

I completely disagree.  It was not just the Mentor large study that was so outrageous after only 3 years, and Allergan barely kept half their augmentation patients after only two years.

The Adjunct studies were even worse – only 16-23% of the women were still in the studies after 5 years.  The Core Studies were slightly better, but Mentor had only 58% of their patients at 8 years, and that is not acceptable in any of the places where I have conducted research.

Our nonprofit has talked to many women who have had serious problems with their breast implants, and I am talking about recent patients, not patients from 20 years ago.  But, many of these patients have already missed work because of their illness and couldn’t take the time to be here this week.  Some told us that their kids are going back to school this week, and they need to be there.  Others didn’t even hear about this meeting in advance – it wasn’t exactly highly publicized to the general public.

But history should be our guide.  We know that most new breast implants seemed great at first.  It isn’t until years later that it becomes obvious that the “newer safer breast implants” also break and leak and cause problems.  So, it may take a few years to get a better idea about the safety of the “new cohesive gel implants” but we already know after yesterday’s testimony and from talking to many other patients that these new implants can bleed silicone into the scar capsule even when the implant is intact.  And even the new implants can break.

I also want to correct some misconceptions that were reflected in yesterday’s panel discussion.  The large studies done by Allergan and Mentor are not asking women to come to the plastic surgeon’s office every year.  Most years, they are asking women to fill out a questionnaire, which they can do online at home.  I have seen copies of these questionnaires and they are much too long.  By the time women get to the questions about their symptoms on page 22 of the Allergan questionnaire, for example, they will have already answered questions about 20 connective tissue diseases, many of which they never heard of and can’t pronounce, such as eosinophilic fasciitis.  They will also have answered the same 20 questions about each of their children.  I have to assume that by the time they get to page 22 to answer questions about symptoms they might actually have, they are in no mood to answer the question about “dilated red blood vessels under the skin surface that appear as red marks, especially on the face, hands, and lips.”  Given these questions, I think it is very unfair to blame the low response rate on the patients.

Similarly, Mentor patients have told us that the symptoms listed on their questionnaire were often confusing and difficult to answer.

I have one more thing to add.  The first 2 years of the Allergan and Mentor Core studies showed that self-esteem on the Rosenberg Self-esteem scale went down in most patients with implants, and that symptoms of connective tissue diseases went up.  Those data were reported at previous FDA Advisory Committee meetings.  But, those data are missing from the analyses that the FDA has reported for the 8-year and 10-year Core study follow-ups.  I ask the FDA to explain why.

Thank you for your time.

Diana Zuckerman, PhD, October 6, 2011

Conclusion of Post-Approval Studies: Many of these rates are too low to provide useful data for augmentation patients.

Rupture Rate: The FDA mistakenly reported the rupture rate per implant as if it were per patient. Previous data shows that the price per implant is approximately twice as high as per implant.

Why the Poor Follow-up?

Once company did a much better job than other. There is no excuse for Mentor’s poor performance because their patients and studies are like Allergan’s.

Plastic surgeons tell women that complaints are so safe that the women aren’t concerned about follow-up. Does the contribute to patient’s lack of interest in participating in these studies? Or are incentives poor? In addition, women are being “fired” by their plastic surgeons.

Cumulative Complications

Cumulative complication rates are decreasing in data the FDA has presented now compared to a few years ago! That’s impossible. They should stay the same or increase from 4 years to 10 years. (Allergan: swelling decreased from 23% to 9%)

Since come complication rates are going down there is a problem with the data. Either the company is not reporting complications correctly or the sample is changing in ways that reduce complications.

Cumulative Complications

Mentor seems to have stopped reporting certain complication rates. For example, asymmetry. For example, asymmetry and ptosis, 2 complications for reconstruction patients, are simply not reported at 8 years.

What else might Mentor have decided not to report?

Given these problems, it is difficult to have faith in the integrity of the Mentor data.

Conclusions:

Incentives are lacking for companies or surgeons to do post-market research correctly. Enforcement is needed to provide incentives.

Data are not capturing the problems many implant patients report-especially Mentor.

Literature is funded by silicone and implant companies, and medical foundations with conflicts of interest.

Pam Noonan-Saraceni

I was diagnosed with breast cancer and had a mastectomy at the age of 25.

I waited 5 years before I decided to have reconstructive surgery. I played tennis, jogged, and taught aerobics.  But the prosthesis often shifted or fell out of my bra when I perspired.  So, as a well-educated woman, I did my homework on breast implants prior to choosing the plastic surgeon to perform my reconstructive surgery. However, I was told that they would “last a lifetime” and “complication were rare”.

Within 3 months of the initial reconstruction, I was back on the operating table. My body had formed a capsule around the implant and the implant had shifted up under my collarbone. The searing pain at that time was causing my shoulder to become immobile.

My symptoms began slowly. At first I attributed the fatigue, aches, and pains to just getting older. (I was only 36 years old!) This was 6 years after I had been implanted.

Then I got a severe case of the flu, and 6 weeks later I was still so fatigued that my life was being drastically effected. I had GI problems, sleep disorders, night sweats, chronic fatigue, myalgias, and joint pain.

Before I had the implant removed  (10 years after the initial reconstruction), I was again wearing a partial prosthesis over the implant. Capsular contracture had again become a problem and I was misshapen and lopsided. The explantation was the 5th surgery at my breast site.

I never fully recovered.  I have gone to various doctors and specialists and have been given a list of various possible diagnoses. Atypical Connective Tissue Disease is number one, but that diagnosis was made quite a bit later, not within the first 10 years.

To date, my out of pocket medical expenses exceed $40,000. My husband and I are self-insured. The insurance policy that we took out carried an exclusion. I was not covered for any illness or disability related to the reconstructive surgery. Apparently the insurance companies understood that there are health risks associated with breast implants and they are not willing to bear the financial costs.

There is not a miracle cure for me. But I hope that by telling you what happened to me, you will understand why better research on breast implants is so important.

Kathleen Van Fossen Nye

My name is Kathleen Van Fossen Nye and I am from Reading PA. I am not well enough to travel to this meeting so I thank you for the opportunity to have my words read before this panel.

I first got breast implants after undergoing a bilateral mastectomy at the age of 22 at the U.S. Naval Hospital in Portsmouth, VA.

My experience with implants is like a history book on breast implants, because I started with some of the early implants and those were repeatedly replaced as newer models became available.

I beseach you to make sure that well-designed and implemented long-term studies are conducted on all breast implants that are sold. Then make these studies available to the public on the internet so women can read them for full disclosure.

When I was 22, the doctor claimed I was lucky to live when reconstruction was available with silicone breast implants. He said before the implants I would have walked around with a sunken chest. He also said they would never sag, that I would be the sexist old lady in the nursing home. In addition, they would self-seal if I was stabbed in the breast.

I wasn’t so lucky, after all.  My original breast implants had to be cut off my chest wall, because the mesh backing from the implants grew into the chest wall. The implants had become as hard as rocks.

I was told that the new silicone gel implants were greatly improved and would not get hard. In addition, if for any reason they do get hard, all the doctor had to do was squeeze the breast until they break the scar tissue capsule.

Claims of being able to break the scar capsule were not true. After 5 years of squeezing the hardened breast, I could no longer take the pain. My doctor told me it was my fault because I had no breast tissue. However, he told me that the new Meme implants were covered with polyurethane foam that would stay soft and never get hard, so he was going to use these new and improved implants.

When asked about the safety of the foam, I was told to trust the doctor because he knew what was best for me.

And yet, the new implants also got hard.  The old Meme implants were removed and I had surgery to get a new set of Meme implants.

For 3 years I was weak and sick and after visiting three different doctors complaining of pain and lumps on the edge of the implant, two doctors told me it was scar tissue. The third doctor said to give me peace of mind he would remove the lumps. The implants were removed and the 3 lumps were biopsied.

Foreign material was found in two of the masses.  The mass that was sandwiched between the other two was cancer.

After chemo and radiations treatments I had two expanders and I was implanted once again, against my wishes.

Within 3 months, I developed necrosis and the implant pushed itself up and out through my skin.

My physical health has suffered greatly. I have had over 25 breast related surgeries, including 6 sets of implants and 4 single silicone implants, 2 expanders, and 4 individual saline for the left breast.

I now have lupus and many other health problems.

I have given my history to show you that there is always great optimism about the newly designed implants, but as the years go by, the optimism gives way to reality and those old implants are always replaced with new ones, until those new ones become the bad old implants that need to be replaced.

It is 49 years and about 3 generations of women since Drs Cronin and Gerow implanted the first breast implants. If the manufactures’ make safety claims, they should back them up with studies that really provide accurate long-term data, not biased samples where half of the patients are missing and we don’t know if the half that are missing are healthy or terribly sick.

Anne Stansell

My name is Anne Stansell and I live in New Mexico.  I wish I could be there today, but I hope you will listen to my story.

I am a breast cancer survivor. I was diagnosed at the age of 39. The doctor said I needed mastectomies, radiation therapy, and breast implants. Implants were just part of the treatment, no discussion. I trusted the doctors who I felt had just saved my life.

I was fine for the first five years. Then I became very ill. I was diagnosed with Graves Disease and fibromyalgia. My eyes were so dry that my retina tore.

My implants were taken out about two years later. I had to fight with my insurance company to get them to cover the removal.

Half of one of my implants was gone. Where did the silicone go? I don’t know.  Here is a photo of me with my half empty implants.

They couldn’t remove all the silicone from my body, but even so I began to get better almost immediately. My family noticed the difference even before I did.

I’m still recovering, and I can work some now.

When I heard about the new post-market studies, I saw that the complication rate was high, but was surprised that the complication rate wasn’t even higher.  I had many of the same local complications. I can’t even remember how many surgeries I needed. Silicone was found in my side, when it migrated from the broken implant.

At a previous meeting, the data indicated that cancer patients and augmentation patients also had an increase in some autoimmune symptoms during the first two years after getting implants. I think my symptoms started in the third year, so it is likely that those signs and symptoms will increase over time, just like mine did.  But it doesn’t seem that the post-market studies measured symptoms.  It seems that they just measured diagnosed diseases.

When the FDA approved breast implants, they demanded post-market studies to find out how often these debilitating complications occur.  But based on the women I’ve talked to with breast implants, it seems that the women with implant problems tend to stop going to their plastic surgeons and are therefore dropping out – or being intentionally dropped out – of the studies.

I didn’t have informed consent as a cancer patient, and from what I hear from other patients, that is still true today.

This meeting is focused on research but to do the right research, you need to listen to the patients who were harmed by implants.  We illustrate the data. We are the examples of what can – and has – happened to tens of thousands of women across the country.

Carolyn Wolf

My name is Carolyn Wolf; I live in Virginia. I have paid my expenses to be here and I have no conflicts of interest.

At 41, I had subcutaneous mastectomies due to fibrocystic disease.  Reconstruction was with Dow Corning silicone implants (1972).

Seven years later, small burning blisters formed on my neck. I stopped wearing neck jewelry, though allergy tests were negative. I wear no makeup.   I continue to develop these blisters, and other implants report they have similar blisters.

By the 15^th year, my implants had become very hard; after 17 years I was hospitalized for 3 days with all the  symptoms of a heart attack, but tests showed no heart problems. I asked the internist “could the implants have caused this?” and was told “no”. In hindsight, I think this episode was the result of silicone leaking from my left implant.

Three years later, I had developed joint problems on my left side,  my shoulder, elbow, knee, ankle and foot. Gradually my fingers and toes became numb.

I went for checkups every year at Walter Reed. No suggestion was ever made for an MRI until a bubble appeared on top of my right breast, about 26 years after getting implants. Because there was a long wait to get an MRI, a radiologist did an ultrasound. The report was “no cancer, everything okay”.

About a year later, I started feeling burning in my scalp; it felt like a red hot worm crawling along the part line.  I also had three episodes when long strings of silicone came out of my ear.

Twenty-eight years after implantation, the left breast collapsed fully.  I finally had my firstMRI, which showed both implants extensively ruptured. When the implants were  surgically removed in 2000, the total material that came out would not have filled a small sized Styrofoam coffee cup.  Obviously the rest had leaked or deteriorated into my body.

Because of continuing dizziness and brain fog, a brain MRI was performed in 2001.  This showed more than 20 lesions on my brain.  EMG tests showed much damage to my left eye, to my left arm and hand, and extensive neuropathy in the extremities. The neurologist studied a Mayo –he was no charlatan.

Three years ago I was hospitalized with Giant Cell Temporal Arteritis, with the same pain in my scalp.  I have been able to control the inflammation with high doses of Prednisone.

I am diagnosed with connective tissue disease, multi-nodal thyroid chronic fatigue; fibromyalgia, PMR, asthma and COPD; MS-like syndrome with neuropathy; platinum poisoning (my platinum lever is 140, 35 times normal by CDC/OSHA standards), and Irritable Bowel Syndrome.

I am not the only woman with these kids of experiences.  There are still thousands of women who have had leaking silicone breast implants in their bodies for decades.  Many cannot afford surgery to remove them. Others, like me, had doctors who told them that their health problems are unrelated to their implants.  In recent years, many of those doctors are saying “the FDA says they are safe and leaking silicone does not cause problems.”  And many women believe the doctors, and just get sicker and sicker.  Many of them just “give up” and even commit suicide – and it is NOT because they don’t have knobs on their chests.

I ask the Advisory Committee to think about how your recommendations will affect these women.  Why is there no research focused on the women with leaking silicone implants and what happens to them??  The FDA did such a study 10 years ago, but the manufacturers say the newer implants are safer.  But there are not studies to PROVE whether that is true, because the studies required by the FDA follow women for only 10 years.

Is the FDA willing to publicly state that silicone and platinum leaking into women’s bodies, year after year,  is “perfectly safe”?

So far, the FDA keeps requiring the companies to do research, but the research if NOT getting done properly.  Women are being terribly harmed as a result.

Please make sure that these research requirements are enforced.

Conclusions of Pam, Kathleen, and Anne in their Joint Testimony

So far, the post-market studies have all started studying women from the time they got implants for the next 10 years — although many women dropped out of the studies before 10 years had passed.  In our experience, many women with implant problems have told us that they no longer felt welcome in their plastic surgeon’s office, so they sought health care from other doctors.  We are concerned those are the women who dropped out of the post-market studies.  If they are, then the complication rate is much higher than the studies are reporting.

We have heard on the news where plastic surgeons say that breast implants have been studied more than any other medical device.  We don’t know if that is true, but if it is true, that is an indictment of research on other medical devices.  The studies of breast implants aren’t asking the right questions.  You need independent researchers, not the implant companies, to do this research.

We may not be your typical breast cancer reconstruction patients, but we have talked to a lot of women who have stories just like ours.  The FDA needs to interview women like us, and ask questions about our kinds of symptoms.  Then, include those symptoms in the studies that are done.

And why not find the women who were in the implant studies that started 10 years ago, and follow them for the next 10 years?  Complications are much more rare at first and increase over time.  So, starting with women who had implants put in 10 years ago would provide much more useful safety information than starting with women who got implants 2 years ago.