Who's Minding the Store at the FDA?

I have sitting in front of me a letter dated October 14, 2008 addressed to Representative John D. Dingell. Representative Dingell is the head of the Committee on Energy and Commerce in the Congress.

The first paragraph of the letter states:

“This letter seeks your urgent intervention because of serious misconduct by managers of the U.S. Drug Administration (FDA) at the Center for Devices and Radiological Health (CDRH) is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA’s mission to protect and promote the health of all Americans. Mangers at CDRH have failed to follow the laws, rules, regulations and Agency Guidance to ensure the safety and effectiveness of medical devices and consequently, they have corrupted the scientific review of medical devices. This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation (ODE).”

The letter is redacted (certain sections blacked out) including who sent the letter. It is on the letter head of the Department of Health and Human Resources which is the branch of government responsible for oversight of the FDA.

This is a five page letter that makes clear a shocking point many times over. “There is documentary evidence than managers at Office of Device Evaluation have corrupted and interfered with the scientific review of medical devices.” The documentary evidence has been characterized as “compelling, convincing and sufficient enough to justify curative and disciplinary actions.” According to this letter, the written documentary evidence would seem to include internal emails, reviews, meeting minutes, etc.

There are hundreds of medical devices that are regulated by the FDA. These include silicone and saline breast implants, cardiac stents, imaging equipment and nerve stimulators.

From the dates in this redacted letter, these accusations of corruption were first presented to FDA officials on May 31, 2008. Six months ago. It was determined by an internal FDA official that the evidence was “compelling,” “convincing,” and “sufficient” by the end of August of 2008.

So where is the public warning? What devices have been called into question? What if you or your loved one was getting a cardiac stent tomorrow or choosing to have breast augmentation or breast reconstruction with implants?

I would advocate that it is the FDA’s responsibility to sound an alarm to the public clearly and swiftly if there is any doubt on the validity of the approval process of any device they regulate. Internal investigations are called for and needed but where the public warning.

In November of 2007 there was a report issued by the FDA Science Board entitled “FDA Science and Mission at Risk.” The report states, “The industries that the FDA regulates are among the most successful and innovative in our society, and are among the few that contribute to appositive balance of trade with other countries. The importance of the FDA in the nation’s security is similarly profound…THUS THE NATION IS AT RISK IF FDA SCIENCE IS AT RISK.”

So how many people are there walking around today with one of these medical devices in question? Do they not have a right to know?

Write your elected representative and demand Congressional hearings.

Johnson & Johnson Goes Into the Breast Implant Business

This year, the economy has been front and center on everyone’s mind. Bailouts, banks not lending, high unemployment, people cutting back, the mortgage crisis, etc., etc.

Natasha Singer wrote an article recently in the New York Times, Putting Vanity on Hold. Her article discusses the ramifications the downturn of the economy will have on cosmetic surgery. Will it slow down? Will people still make it a priority? The by–line of the article is:

Americans have been plastic surgery-obsessed. In a recession, will ideals of beauty loosen up?

I read one thing towards the end of the article that made me think at least one huge American company thinks not. In December 2008, Johnson & Johnson announced it will buy Mentor Corporation, one of the leading manufacturers of breast implants for about 1.1 BILLION dollars. Yes, that is 1.1 billion dollars in an economic downturn that some suggest is reminiscent of the Great Depression. Yet, Johnson and Johnson will buy Mentor Corporation for this huge sum of money. Johnson & Johnson must have predicted that Mentor’s profitable breast implants business is recession proof. Women will still be spending their hard earned dollars on breast implants.

When I think of the company Johnson & Johnson, I think of babies – baby lotion, baby bottles, and baby shampoo. Brings to mind the virtues of purity and caring. I went to their website and read their company credo –

“The values that guide our decision making are spelled out in our Credo. Put simply, our credo challenges us to put the needs and the well-being of the people we serve first.”

In this case, Johnson & Johnson has a great deal of work to do when they acquire Mentor Corporation. Given their credo they will have to devise a way that is accessible and transparent to provide Informed Consent to the women that will choose their new product –breast implants.

In my documentary film, Absolutely Safe, I raised several questions about breast implant safety. The quality and quantity of the safety studies on implants, the possible risks and complications and how much women understand what those are, why women choose this product and the question of long-term safety of breast implants, to name a few. One of the characters in the film, Wendi, chose to have her silicone implants removed after 20 years. Her implants had disintegrated into a sticky mess.

I continue to hear stories of implants gone bad, re-operations for ruptured implants, infection, hardening of the implants, and removal of the implant due to pain. There are serious and very real complications and risks with breast implants. And there are serious and very real unknowns about the long-term safety of implants.

Women deserve to be informed. They deserve Informed Consent. The Johnson and Johnson credo is needed here – “Our credo challenges us to put the needs and the well-being of the people we serve first.” Women and their health need to be put first. Let’s pray that Johnson and Johnson takes on that challenge. It is essential and so needed in the discussion of breast implant safety.

Never Having to Wear A Bra Again

October is Breast Cancer Awareness Month. It is an important time to inform and educate everyone—men and women—about breast cancer detection, prevention, and treatments. Yesterday, the Oprah Winfrey show dedicated its hour to this very topic. The show began with Christina Applegate bravely sharing her story. I applaud her openness and Oprah’s dedicating her show to this issue. Christina discussed her decision to have a radical mastectomy and her decision to be reconstructed with saline implants. She explained the procedure of getting saline implants after mastectomy, the placement of breast expanders, and the later implantation of saline implants. She then said “I’ll never have to wear a bra again.” That took my breath away for a second.

My mother went to the Mayo Clinic in the early 1970’s and she was told to have a radical mastectomy and have her breasts reconstructed with silicone implants. Her surgeon told her the same thing--“You’ll never have to wear a bra again!” Two years after that surgery her implant ruptured and she had it replaced. Very shortly after that it ruptured again. My mother has suffered a great deal of pain from the several surgeries, complications from the implants, and subsequent health problems. Not having to wear a bra was a very insignificant benefit given the many serious problems she had with her implants.

Now, one might say that this happened years ago and now implants are safer, the surgery has been perfected, and even the FDA has approved both saline and silicone implants. I think this is far from the truth. Somehow, the known risks, the known complications, and unknowns about the long-term safety of both saline and silicone implants are being lost. Don’t forget that the FDA and implant manufacturers fully acknowledge that breast implants carry known risks, like rupture and capsular contracture. The safety dispute emerges regarding the “unknown” risks like severe allergic reaction to the chemicals and platinum salts used in both saline and silicone breast implants.

I watched the Oprah show yesterday and by the end of the hour I was filled with a profound sadness and anger that I didn’t hear any discussion about the safety of implants. There was not even one word mentioned about risk or safety questions. And, breast implants, both saline and silicone, are only one of the reconstruction options for mastectomy patients. There are other reconstructive procedures available to women, using the patient’s own fat (from other areas of the body) to rebuild the breast. Or, there are some very gifted medical artists who sell breast prosthesis that require no surgery. Visit New Attitude Inc. for more info on this...

On yesterday’s show there was an oncologist, the head of the Susan Komen Foundation, and several breast cancer survivors. The conversation was important and informative but missing an important chapter—other options that may be safer and perhaps even less expensive for women.

Today, I went to the Oprah website hoping to find some supplementary information about the safety of breast implants and it wasn’t there. I am so struck by the seeming lack of information presented to women and to the public. There are important organizations that every woman facing this choice should contact.

Judy Norsigian, the Executive Director of Our Bodies Ourselves, has stated “We know breast cancer patients want to make informed decisions, but that just isn’t possible when the necessary long-term research has not been done.”

Breast Cancer Action has a statement about the FDA approval of silicone implants, “Breast Cancer Action is alarmed and concerned that the FDA has once again erred on the side of industry at the expense of women’s health.”

The National Center for Research for Women and Families issued a report in 2006 called Decisions in the Dark. Do breast cancer patients choosing silicone implants know that Inamed Corporation’s three year study on silicone implants that 46% of the reconstruction patients had a re-operation in the first three years? Do they know that Allergan, one of the leading sellers of breast implants today, states in all of their ads “Safety and effectiveness have not been established in patients with a weakened immune system.” And, that “The health consequences of a ruptured silicone gel-filled breast implant have not been fully established.”

Where is the balanced information so that women can make an informed choice? I applaud Oprah and Christina for talking about breast cancer and mastectomy, but such discussions must at least acknowledge that breast implants carry known and unknown risks. Never having to wear a bra again is the least of our concerns.

Breast Cancer Patients Have Other Choices-They're Just Not Offered

New York Times journalist Natasha Singer has written another important article regarding breast implants, Some Hidden Choices in Breast Reconstruction. This time, she explores alternative choices to breast implants for reconstruction patients. Too often, these non-implant choices are not offered or even mentioned to patients.

"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 incentive to offer them, doctors say."

It seems tragic that profits are preventing women from having all the choices they deserve when it comes to reconstructing their breasts.

Read more of this New York Times article.

Will the Recession Affect Cosmetic Surgery?

Today's New York Times features a terrific article by journalist Natasha Singer about the effect of the economic downturn on the cosmetic surgery industry:

"But now, as the country plunges into recession, will financial hardship demote the pursuit of physical perfection?

Will the vogue for a smoothed face in which only the mouth moves, or a mix-and-match body of mature breasts atop boyish hips become outmoded? Will aesthetic values loosen up, allowing the occasional wrinkle to take on a certain measure of authenticity?"

Read the article in the New York Times

BREAST CANCER ACTION-Hormones and Breast Cancer

The renowned organization Breast Cancer Action has started an important campaign to raise awareness about the health concerns concerning the synthetic hormone rBGH.

There are serious health questions regarding this hormone and the health of women's breasts. General Mills continues to use this hormone in the making of its dairy product Yoplait yogurt.

We urge everyone to participate in Breast Cancer Action's campaign to tell General Mills and Yoplait Yogurt to stop using this hormone.

Please join the THINK BEFORE YOU PINK campaign and help Breast Cancer Action.

F.D.A. Medical Device Decision Making-Misconduct?

Yesterday, The New York Times published an article about the Food and Drug Administration's possible misconduct in its medical advisory review process. Breast implants are reviewed as medical devices and these allegations may possibly involve breast implants.

Here's an excerpt from the New York Times article:

"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 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."

Did the F.D.A. ignore scientists' opinions when it made its silicone breast implant approval decision in 2006?

Did senior F.D.A. management corrupt the process and violate the law?

Stay tuned into this story--if experts were coerced into changing their opinions regarding any medical device, this is very serious.

Read the New York Times Article in its entirety.