Hello All,

President elect Obama’s team is asking for input on health care reform during the month of December.

Let you voice be heard!

We wanted you to know about this so you can go to the web site and give your thoughts.

Here is the link to the web site. Register your comments there.

Please go there and fill it out the simple form. We have written something you can cut and paste into the comments section, or you can write your own. See below for our request or in the attached file.

Please send this to your friends,family, web sites, post it on your Blogs, and send to your mailing lists. Get the word out there.

As we all know the FDA needs help and can use an overhaul so they can hold the manufacturers responsible and accountable to their commitments.

Feel free to cut and paste the below comment.
Pass it on.
Thanks. Happy safe Holidays to you all,

Sybil and Mary

_______________________________________

Over the past several years, we have seen that the FDA has not been up to the job of protecting our nation’s health. This problem has been especially apparent in the area of medical devices. The New York Times recently reported concerns that the FDA leadership has regularly ignored concerns of agency scientists and approved unsafe or ineffective medical devices.

We have seen these problems firsthand in the area of silicone breast implants. No one knows what effect these implants will have on women’s bodies beyond 10 years because the research just hasn’t been done, yet silicone implants were put back on the market in 2006 and since then have become the most popular plastic surgery in this country.

Despite this approval, there are still just too may unanswered questions about the safety of silicone breast implants. The facts are clear. Implants have caused serious health problems. We deserve to have a product that works safely. But right now, the FDA simply doesn’t have the authority to demand the science to prove that implants are really safe.

It is vital that the FDA be given the resources and the authority to insist that products are safe before they are put on the market and implanted into our bodies. The consequences are too dire to needlessly experiment with our health and our lives.

I reached an important anniversary on November 29th.  Four years ago, I had my breast implants removed.    

I, like many women, had breast augmentation because I didn’t feel very feminine.  I felt boyish and awkward in my thin body.  Too tall, too thin, too lanky, UGH!  I could have gone on and on with everything I felt was wrong with how I looked.  In reality, all this was in my head.  My perception of myself was very misguided by air brushed photos and beautiful movie stars that looked nothing like what I saw when I looked in the mirror.  This is something that I became obsessed with changing.

 It has been a very long journey for me.  Back in 1996, I made the decicsion to have my breasts augmented.  Feeling thilled with my outcome and finally feeling like I had a better body image, no one could tell me what lay ahead for me.  

In 2001, I became completely disabled and it took another 3 years to find out that my implants were making me very ill.  Those three years really delayed my recovery as I found myself becoming more and more ill and suicidal.  On October 19, 2004, I attempted to take my own life.  Unfortunately, this is another date that I will never forget but I have been able to rise above all of this and have slowly been getting pieces of my life back again along with my health. 

My implants were removed on November 29, 2004.  I have made so much progress since then.  I’m still disabled but my health has been slowly improving.  I feel better now than I have in many, many years.

Like Krista mentioned in her post regarding her explant anniversary, I look at this as a lesson learned.  I no longer look at women with big fake breasts and think they look beautiful.  The entire experience has changed the way I look at myself.  Surprisingly so!  Fake breasts are just not very attractive to me at all. 

 This experience has had other positive effects as well.  I no longer abuse my body with the wrong foods.  Healthy food and exercise are all part of my life now.  Sure I still have some body issues.  The only difference now is that I look to exercise in trying to improve my look.  This is something that I wish I would have thought about years ago. 

I’m angry that so many have lied to me about the safety of breast implants so I use my experience and research to educate other women.  Women should have all the facts prior to having something like this done.  In my opinion, there is nothing safe about breast implants.  You are inserting a foreign object in your body that has many chemicals in it.  Chemicals that cause cancer and autoimmune related diseases.  There is so much that can go wrong with this type of surgery. 

For all the ladies out there thinking of having this done, please do your research.  Thoroughly do your research and make sure you read the chemical list.  Seeing that alone 12 years ago would have made me realize that these are not safe to put into the body.  Don’t be fooled into thinking that only silicone gel implants contain these chemicals.  The outer shell of a saline implant is silicone so you are being exposed to these chemicals with all implants.

This indeed was a hard lesson learned!

beth

KATY PERRY has insisted “the rack is real” - hitting back at rumours that she has breast implants.

The controversial I Kissed A Girl singer is furious at suggestions that she’s had work done on her breasts.

Flaunting the goods in question, Katy ranted: “How could people think these are fake? Look at ‘em. Ask them! They are as real as real can be. One hundred per cent genuine and untouched… well sort of.”

“I would never spend money on fake boobs. Shoes, maybe. A handbag, maybe. But plastic tits – no way!”

Katy – who is dating GYM CLASS HEROES star TRAVIS McCOY – added: “I am not against people who get things done. A tuck or a lift never hurt anyone. In 50 years time I may look like a Siamese cat in a wind tunnel but as of this moment I haven’t and the rack is real.”

Here is another example of how we have heard about how safe some of these fillers are when used in the body.  I have been a skeptic all along.  Just biding my time waiting to hear about complications.  I ran across this article that says fillers, Restylane and Juvederm can cause blindness.  What shocked me was that some are using SILICONE oil!  I’ve read that fillers like Restylane is a natural substance found in the body.  Well NOT if it can cause blindness!

I’m glad that the NYT came out with the article.  Maybe it will make women stop and think before using these fillers anywhere on the body. 

COSMETIC doctors have a new way to mitigate tear troughs, those shadowy under-eye indentations that are the bane of people trying to camouflage an aging appearance: the injection of viscous substances around the eye socket.

But as more doctors embrace the procedure, some physicians said they were seeing more complications. While the Food and Drug Administration has approved dermal fillers like Restylane and Juvéderm for treatment of facial wrinkles and folds — a use for which those substances have a high safety record — the fillers have not been approved for the eye area. Nonetheless, several thousand physicians now offer off-label under-eye injections, according to the estimates of six doctors interviewed recently. At a recent plastic surgery conference in Chicago, doctors anecdotally reported an increased incidence of short-term under-eye mounds, discoloration and persistent hard nodules. There are also a handful of reports by doctors in Japan, Brazil, South Korea and Austria of blindness caused by cosmetic injections of silicone oil, fat and other materials under the eyes. Now some doctors are growing concerned. “Certainly I wouldn’t’t do it myself or have it done on me,” said Dr. René S. Rodriguez-Sains, a Manhattan oculoplastic surgeon. Five years ago, he saw four to six patients a year with problems caused by under-eye injections performed elsewhere. This year, the number has risen to one or two patients a month. On Tuesday, the F.D.A. held a public meeting to review facial fillers and to examine whether their popularization is getting ahead of safety and efficacy studies. In the past, the agency has required companies that market fillers to conduct small, short-term trials before approval, as well as post approval studies. Representatives of manufacturers and medical societies addressed the F.D.A.’s panel to assure them that the materials are safe. A representative of Allergan, for example, said that it had sold a million syringes of Juvéderm in the United States since 2006 and received reports of complaints in less than 0.25 percent of cases; the most common problem was swelling. Juvéderm is a gel made from sugar molecules called hyaluronic acid that temporarily reduces nasolabial folds, the wrinkles from the nose to the corners of the mouth. Another hyaluronic acid filler is Restylane, from Medicis Pharmaceutical. Other approved fillers include Radiesse, and ArteFill, which contains permanent nonabsorbable plastic beads.

Doctors in the United States performed about 1.5 million soft-tissue filler injections last year, up from about 1.2 million in 2006, according to estimates from the American Society of Plastic Surgeons. With the growing popularity of the treatments, the F.D.A.’s advisory panel on general and plastic surgery devices met to weigh whether the agency should require makers to conduct longer-term and larger studies with a greater representation of skin types, and histological studies of tissue response to injected particles.

The panel also considered how manufacturers might study safety and efficacy in unapproved uses in the lips, nose, hands and under-eye area. The concern is that other body parts may have a different physiology in which tissue cells may react differently from facial skin, with the potential for complications.

“In a nonapproved case, it’s essentially a little research project going on because we don’t know if these tissues and structures in that area are going to behave in the same way as the tissue the device was approved for,” said Stephen Li, the president of Medical Device Testing and Innovations of Sarasota, Fla., a company that develops materials for medical implants and a consultant to the F.D.A. panel.

Patients aren’t always aware that treatments they are having are off-label. The F.D.A. prohibits companies from marketing unapproved uses. Representatives from Allergan, Medicis, BioForm Medical (the maker of Radiesse) and Artes Medical (the maker of ArteFill) said they did not promote off-label uses. A spokeswoman for Sanofi-Aventis, the company behind Sculptra (approved to treat facial fat loss in H.I.V. patients), said it neither promoted off-label use nor trained physicians to perform such indications.

But doctors are free to use fillers as they deem appropriate for individual patients. For example, several medical societies have created injectablesafety.org, which covers both approved and unapproved uses of dermal fillers; the site is financed by grants from BioForm, Artes and Medicis.

The F.D.A. has reports of facial lumps that formed after off-label use of Sculptra; of localized dead tissue following the off-label use of Radiesse; of lumps, swelling and discoloration after off-label use of Restylane and Juvéderm; and letters from doctors concerned that the off-label use of ArteFill has the potential to cause serious problems, according to the agency’s online database on device complications.

Doctors said that lumps formed by hylauronic acid gels like Restylane and Juvéderm had a remedy: injections of an enzyme that disperses the material. Lumps formed by longer-lasting fillers may require excision. But there are no comprehensive statistics because the agency requires manufacturers, not doctors or patients, to report problems.

Last year, the F.D.A. received 160 reports of problems connected to filler injections, according to the agency’s Web site. But, if even 15 doctors in America treated the same number of complications a year as Dr. Rodriguez-Sains, that would amount to more problems than those listed last year in the F.D.A. database.

In 99.5 percent of cases, doctors inject fillers without incident, said Dr. Bruce L. Cunningham, a plastic surgeon in Minneapolis. “It’s safe most of the time,” he said. “But when there is something that goes wrong like lumps, bumps or, more importantly, necrotic tissue, it does stick out in doctors’ minds because it is so different than what we usually expect.”

Still, Dr. Cunningham told an audience of doctors at the meeting in Chicago that the prospect of increased regulation “is enough to send the shiver of death up your spine.”

Some doctors are concerned that the F.D.A. might interdict such popular off-label uses of fillers as lip-plumping, which many physicians consider safe, he said.

Dr. Brian S. Biesman, an oculoplastic surgeon in Nashville, said he would welcome more study. In his office, patients who undergo under-eye injections sign a form consenting to the nonapproved use of a filler and acknowledging the risk of vision problems, he said. “If the F.D.A. were to encourage the companies to get more data or if the F.D.A. were to require it, I think it would be great,” Dr. Biesman said.

Dr. Julius W. Few, a plastic surgeon in Chicago, said that ancillary medical personnel and doctors who lack expertise in cosmetic treatments were responsible for most filler complications.

But Dr. Richard D. Lisman, an ophthalmic plastic surgeon in Manhattan, said that all injections around the eyes — even steroids or lidocaine for medical purposes — entail rare risks like vision loss, even when performed by eye surgeons. If doctors are reporting more lumps from injections, it is because more doctors are performing the technique more frequently, not because of a flaw in the filler, he said. He himself does not inject fillers in an off-label manner, he said.

“When you have an increased quantity of periorbital injections and an increased number of specialties injecting, it’s a natural consequence to see a very small but very real downside,” Dr. Lisman said.

 beth

Listen up ladies! For those of you who believe that the FDA ensures your medical devices, food and medicines are safe…..you may want to read this!

This article was in the NY Times today.

F.D.A. Scientists Accuse Agency Officials of Misconduct
By GARDINER HARRIS
Published: November 17, 2008

WASHINGTON — Top federal health officials engaged in “serious misconduct” by ignoring concerns of scientists at the Food and Drug Administration and approving for sale unsafe or ineffective medical devices, the scientists have written in a letter to Congress.

The House Committee will investigate the accusations, first aired when eight agency scientists wrote a private letter in May to the F.D.A. commissioner, Andrew C. von Eschenbach.

“These allegations are deeply concerning,” said the committee chairman, Representative John D. Dingell, Democrat of Michigan, “and we intend to uncover whether any F.D.A. activity has compromised the health and safety of American consumers.”

Heidi Rebello, an agency spokeswoman, said, “The F.D.A. will respond directly to the committee’s concerns.”

The letter to Congress, dated Oct. 14, is part of a growing chorus of dissent from what had long been a tight-lipped agency. In decades past, scientists rarely disagreed publicly with their agency’s decisions, and any concerns they had about important decisions were whispered among veterans.

But increasing scrutiny of the agency on Capitol Hill has coincided with a growing willingness by some scientists to voice their misgivings. The disputes tend to pit agency managers, who often lean toward approving drugs or devices when the data are equivocal, against agency scientists, who want more certain trial results before allowing the products to be sold.

Medical devices include products like cardiac stents, nerve stimulators to relieve depression, imaging equipment and breast implants. It is not clear from the publicly released information which device approvals the scientists questioned.

The most recent dispute is unusual if only for the number of doctors and scientists who signed their names to the May letter. Previous disagreements involved at most a few agency scientists. Mr. Dingell and Representative Bart Stupak, another Michigan Democrat, released the letter sent to Congress on Oct. 14 but blacked out the scientists’ names and some crucial details the scientists did not want disclosed.

The letter says that the scientists have documentary evidence that senior agency managers “corrupted the scientific review of medical devices” by ordering experts to change their opinions and conclusions in violation of the law.

Dr. von Eschenbach asked William McConagha, the agency’s assistant commissioner for integrity and accountability, to investigate the accusations, the letter states. Mr. McConagha characterized the documentary evidence supporting the accusations as “compelling” and sufficient to justify disciplinary actions, it says.

Mr. McConagha may have recommended the removal of certain agency managers, Mr. Dingell and Mr. Stupak said.

But a top agency manager, after conducting his own investigation, concluded that the dissidents should “move forward,” and he decided against taking any curative or disciplinary action growing out of the dissidents’ complaints, the letter states. Instead, the letter says, the manager has allowed the dissidents to become victims of reprisals by agency managers.

The letter further says that Congress should consider reforming a process in which, the scientists say, the F.D.A. agrees to approve complex medical devices on the basis of little evidence of effectiveness.

I came upon this article today:

The article states that “A report released Monday concluded that “Gulf War Syndrome” is a legitimate condition suffered by more than 175,000 U.S. war veterans who were exposed to chemical toxins in the 1991 Gulf War.” Wow! “Unexplained neurological illnesses, from brain cancer to multiple sclerosis.”

Sounds familiar to me. For one, I am glad that this condition is being noticed as real, but at the same time I am frustrated. Why don’t doctors and scientists do more research into breast implant sickness? The entirety of the studies that are done funded by implant companies, and not people who are concerned about the wellness of women everywhere. 

This part was shocking - “The committee, composed of independent scientists and veterans, said Congress should boost funding for research on Gulf War veterans’ health to at least $60 million per year.” Wow! We should get that kind of help, too. Every woman I know who is sick from her toxic implants is in medical debt.

Their symptoms are even similar to ours - “Symptoms include persistent headaches, widespread pain, cognitive difficulties, unexplained fatigue, skin rashes, chronic diarrhea and digestive and respiratory problems. Many Gulf War veterans suffering these symptoms say they met with skepticism when seeking treatment.”

Hopefully this will open eyes to more unexplained illnesses like ours. I am happy that many of these vets will finally get help.

A woman from my forum shared this poem with everyone.  I loved it and decided to share it with our readers.  

She said that this is a part of the breast cancer awareness campaign in the UK. 

Enjoy!

Ode to Boobs, by Pip Bishop
Dear boobs,
This heartfelt apology goes out to you all
For moaning you’re too big or moaning you’re too small
For wishing you didn’t hang like puppies in sacks
Or just disappear when we lie on our backs
For squashing you flat with a minimising cup
or those torture bras that push you right up.
Why is it always your bad points we mention
Like your inverted nips or your water retention?
Why don’t we love you as much as our men
Or the babies that love you all over again?
Maybe we’re scared to show you we care
In case, one day, you’re simply not there.

beth

As most you know, today is my one year explant anniversary. To read more about my story, please see the October 22nd post.  As promised, here is what the last year has been like and here is where I am today.

My road to recovery was not easy. The damage was done; the chemicals from the ruptured implant had already gotten into my blood, my lymph system, my organs, my tissues. I found out pretty quickly that there is no “regular” course of treatment for this kind of thing. I was told to eat right, drink lots of water, make sure my body gets the proper vitamins, get plenty of sleep, take all existing chemicals out of my life, keep my stress level down, and sit in a sauna when I could to help detoxify the chemicals. There were times over the last year that I thought I’d never get better.  I’d have weeks at a time where I thought I was recovering, then a month when I could barely get out of bed. I had many many setbacks throughout this time.  Did I want to give up at times? Yes! What got me through…..the strong desire to want to recover & get my life back, and friends that were going through the same thing. There were so many women that gave me strength, hope and good advice to get me through the tough times.

Here I am one year later and I must say that I am a completely different woman then I was one year ago. I’ve returned to my old self, my old life, back to regular health. I do have some lasting effects, unfortunately. They are…..the swollen lymph nodes that never returned to normal, occasional unusual fatigue, brain fog and overall body aches, chronic pain from inverted ribs (from the weight of the implants in my chest wall,) chronic pain in my chest muscle, and my scars that will forever remind me of a lesson that I had to learn on my own. I still have to be careful about how much energy I exert in a days time. I can no longer plan a full days worth of activities like I used to. I still get tired easily and need more rest then I did prior to this illness. I am thankful that my lasting effects are manageable and that I am still able to lead a normal life.

After all this, I am FINALLY realizing and accepting that I am beautiful with or without big breasts, and that big breasts are not what make a woman beautiful. It has taken a lot for me to get to this point. Sure, I still carry a lot of anger and sadness, but mostly I am mad at myself for choosing to put my body through this.  I am mad that I missed out on precious time in my young life due to this illness.  But I know that throughout this ordeal that I have learned so much about myself; as this illness has truly made me look inward to see the woman I am on the inside, instead of focusing on what I looked like on the outside for so long, this has truly been a humbling experience.

I am trying to just look at this as a life lesson, an expensive and painful life lesson…..but nonetheless a life lesson. Part of me of course misses the implants; I’m not going to lie to you. When I look down I do get a little sad, and I do indeed miss the implants at times.  But, I had wanted big breasts for so long and then when I had them, deep down I was still painfully aware that I still didn’t have them, that they were never really “mine,” what I had was a man made object in each breast making the illusion that I had big breasts.  Sure I wish that God had been a little more generous in the “boobie department,” but the other things in my life that have been given to me far outweigh having large breasts.

I’m not going to preach to every woman I meet to never to get implants, or to have them removed if you already have them. I know that everyone has to make the decision for herself, and I more then respect others’ opinions. I’m not totally against plastic surgery, I’m not some crazed feminist…I am a young, regular American woman, just like you.  I am merely telling my story because I think every woman deserves to know and hear the truth; women like me have been silenced for too long. I believe there is too much money behind the breast implant industry, too many people biasing all the information out there, and I believe that every woman deserves to hear the truth. Every woman needs to make an informed decision before getting breast implants, and I am merely trying to make sure that every woman gets that information to be truly informed.

As reported here and here, women with silicone breast implants may have a higher risk of developing a rare form of lymphoma.   This has been determined by a new study.

But the absolute risk of developing this cancer is still tiny, amounting to about 0.1 to 0.3 per 100,000 women with implants each year, according to the Dutch authors of a study published in the Nov. 5 issue of the Journal of the American Medical Association.

“Doctors should be aware of this . . . but it’s not something women should worry about,” said Dr. Mitchell Smith, head of the lymphoma service at Fox Chase Cancer Center in Philadelphia. “People with implants have a one in many hundreds of thousands or one in a million chance of developing this cancer.”

More importantly, Smith said, the finding might help scientists understand the biology of this particular malignancy.

Silicone breast implants have engendered decades of controversy. In 2006, the U.S. Food and Drug Administration lifted a 14-year ban on their commercial use, giving approval to two companies, Allergan Inc., of Irvine, Calif., and Mentor Corp, of Santa Barbara, Calif., to market the implants to all women aged 22 and older.

Neither company responded to requests from HealthDay for comment on the finding.

The implants had been removed from the market in 1992, following suspicions that they might cause cancer or certain autoimmune diseases. There were also concerns that the implants might interfere with the accuracy of breast cancer screening, or that ruptures would cause other health problems.

Researchers have identified previous cases of non-Hodgkin lymphoma in women with breast implants, and most of these were anaplastic large T-cell lymphoma (ALCL).

Normally, ALCL is exceedingly rare, representing 3 percent or less of all non-Hodgkin lymphoma in adults, and there are no known risk factors.

The authors of this study, at the Netherlands Cancer Institute in Amsterdam, searched a national database in the Netherlands for all cases of lymphoma in the breast diagnosed between 1990 and 2006.

They found 11 patients with ALCL, five of whom had had breast implants one to 23 years before their diagnosis. This was out of a total population of 8 million Dutch women over 17 years.

Compared with women who had other types of lymphoma in the breast, women with silicone breast implants had an 18-fold greater risk for developing ALCL.

The authors hypothesized that an immune system response related to placement of the implants or toxic damage from the implants might explain the association.

“There has been a lot of information about silicone and autoimmune disorders,” Smith said. “Lymphomas do occur in other immune-deficiency states where you have chronic stimulation of parts of the immune system. It makes some sort of sense that this could happen.”

beth

As reported here a young woman, age 35 dies of complications due to breast augmentation surgery.  It is sad that we are so fixated on the search for what we might think is the perfect body when in reality, we had it all along.   

SHE was unhappy with her figure, so she went for breast enlargement. But two years on, Ms Wang Xiaobin decided she might have overdone things.

DIED IN VAIN: Ms Wang never got to enjoy her new figure after her surgery. –PICTURE: THE SUN

Her new breasts were too large, she felt.

Worse, they were uneven in size, and not as pert as she would like, reported Hong Kong newspaper The Sun.

In the quest for that perfect cup size, she decided to go under the knife again - this time, for breast reduction.

The plan was to remove the original implants and replace them with smaller ones.

Would this be the perfect pair?

Ms Wang never found out.

The 35-year-old Hong Kong permanent resident died about a week after the operation.

She stopped breathing during the surgery and could not be revived despite repeated attempts by hospital staff.

Ms Wang was originally from Sichuan, China.

She split up with her ex-husband some years ago, and had been living in both Hong Kong and mainland China since.

Concerned with looks

Ms Wang’s ex-husband said that she had been very concerned with her looks and her figure.

She took medication and tried various methods to lose weight.

She also had plastic surgery done to her nose, and to give her double eyelids.

Ms Wang did not tell her family about these operations until they were over.

This final, fatal surgery was no different.

The Sun reported that according to her family, Ms Wang originally had a 81cm bust measurement.

In 2006, she went to a clinic in mainland China for breast enlargement, increasing her bustline to around 86 or 89cm.

She celebrated by having studio pictures taken to show off her new look.

But some months ago, she started telling family members that her breasts were too hard.

On 14 Oct, without telling her friends on family, she went to a clinic to have the implants replaced.

According to medical records, she went under anaesthetic for the operation, which took place in the morning.

But when the surgery was completed, the doctor discovered that her face was turning purple, and her heart had stopped.

She needed a machine to help her breathe, and did not regain consciousness.

Her ex-husband was informed at 6pm, and she was transferred to a hospital for emergency treatment.

A hospital spokesman said that by the time she was admitted, she was already in a very dangerous condition.

Despite their best efforts, she was declared dead on 23 Oct.

beth