'The Bleeding Edge' Netflix documentary July 27, 2018 (Friday)

Netflix's 'The Bleeding Edge' Isn't Even Out Yet and Essure Has Already Been Pulled

"I don't know how anyone could let this happen."

by JENNY HOLLANDER

JUL 23, 2018

Years after the first reports of hazardous effects of birth control device Essure—and days before a Netflix documentary about it drops—manufacturer Bayer announced it will stop selling the controversial implant. The company framed its decision as based on poor sales, but the timing is hard to ignore: The Bleeding Edge, a documentary about medical devices gone awry that uses Essure as a prime example, drops on July 27. Essure was pulled July 20.

"We continue to stand behind the product's safety and efficacy," Bayer said in a statement. The company has maintained for years that Essure, a kind of metal coil that is implanted in the Fallopian tubes to block sperm, is safe, despite facing roughly 16,000 lawsuits from women who say they suffered ill effects after using it, including organ perforation, chronic and excessive pain, and unintended pregnancies. Yet Essure was discontinued due to a "business decision," the company said, citing "a decline in sales."

Meanwhile, Friday marks the launch of The Bleeding Edge, a Netflix documentary from the creators of The Hunting Ground. The Hollywood Reporter describes it as "a terrifying eye-opener," and Indiewire writes that it "stands a good chance at enlightening more people who have been (or might be) hoodwinked." The documentary isn't just about Essure—it focuses on a handful of medical devices that have caused major complications, including "vaginal mesh" and hip replacements—but Essure is framed as a banner example of good intentions gone haywire.

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When it comes to Essure, Bayer has suffered a particularly nasty year. Essure has been pulled or withdrawn from every country where it had been offered outside of the United States—Canada, the U.K., the Netherlands, you name it—and in April, the FDA announced it would be restricting sales of Essure to ensure that all women who consider it are fully aware of the risks. (Restricting sales, in this case, means only selling the device to facilities that agreed to review a set checklist with doctors and patients.) That said: "The FDA continues to believe that the benefits of the device outweigh its risks," the statement noted.

Once billed as the only permanent contraceptive device on the market, Essure has since become a buzzword for unexpected complications. On Facebook and other social media sites, there exists a growing community of Essure-affected women who congregate to share their experiences. Between 2002 and 2017, close to 30,000 women filed formal reports of "adverse effects" with the FDA after using Essure.

You can stream The Bleeding Edge on Netflix from July 27.

https://www.marieclaire.com/health-fitness/a22518890/netflix-the-bleeding-edge-essure/

Bayer Essure: In German or English - Dangerous Birth Control

Tuesday, April 29, 2014

Bayer Stockholder Annual Meeting Speech- English Version

FiDA highlight

Good morning, I’ve prepared something I’d like to read to you. I’ll first speak in English, and then I’m prepared to give the same statement in German if necessary. I have also prepared some questions for the members of the Board.

A few years ago, I had a Bayer device implanted inside me. I chose this device, a birth control device, because it was approved by the United States Food and Drug Administration. This was device was also advertised as safe and effective. The biggest mistake of my life was choosing this device. It would change me, leaving me with permanent reminders of the day I almost died. The physical and emotional scars will never go away.

My name is Michelle Garcia and I live in Miami, Florida. I am an Essure victim, an Essure survivor and a voice to thousands. I stand before you with a simple, yet powerful message. Essure is dangerous and Essure does not belong on the market.

Essure is a form of birth control which is intended to be the non-surgical alternative to a tubal ligation. In April of 2013, Bayer announced the acquisition of a company called Conceptus. During the time they were in existence, Conceptus was never profitable. When Bayer acquired Conceptus, you also acquired Essure. Seven studies following less than six hundred women with Essure were published. The data from these studies was presented when Essure was approved for use in the United States. The same data is also used to support claims the device is safe and effective.

My story goes like this . . . A broken Essure coil pierced my fallopian tube, resulting in internal bleeding and hemorrhaging. Fortunately, while in the emergency room, the bleeding stopped but not before I lost a significant amount of blood and coming close to needing a blood transfusion. I could be dead; I should be dead. As terrified as I was and as frightening as my experience is, there are countless women with stories far worse than mine. For every story we do know, there are thousands more still unreported.

In 2011, a mom named Angie Firmalino, started a group called Essure Problems to warn her friends about the effects this device had on her body. I found the group in May of 2012 when there were only 30 members. Today, worldwide, we are more than 7,000 women strong, 10 times more than the size of your studies.

Gabriela Avina is a health care professional with a Master’s degree in Women’s Health Nursing. She was involved in the clinical trials professionally and became a clinical trial participant in October of 2000. In 2002, she presented to the United States Food and Drug Administration as a clinical trial patient. Gabriela went on to become a spokesperson for Essure, and she toured the United States promoting Essure. Little did she know, the device was slowly destroying her health.

Earlier this year, Gabriella made a second presentation to the United States Food and Drug Administration. During this presentation, she stated that she was wrong when she supported this device 12 years ago. In her own words, she said, “Lives of women have been changed by a device that was not adequately monitored during clinical trials, by physicians who were not adequately trained and by a company that has not adequately listened to their patients.”

So how safe and effective is your device? 3% of the ladies in our group is either currently pregnant or has been pregnant. 2% of the pregnancies ended in death of the child with 55% of our ladies suffering miscarriages. That is a big difference from your published success rate of 99%. The March of Dimes reports the expected rate for miscarriages is ten to fifteen percent.

We prepared a survey so we could collect more specific information from the ladies in our group. The responses support the urgent need to have this device immediately removed from the market. Almost 40% reported issues related to Essure almost immediately after placement with 32% reporting that their coils are no longer properly placed. After successful placement and confirmation of occlusion, the coils may move.

Ectopic pregnancy, which has an expected occurrence rate of 2%, occurred in 14% of our pregnancies. 48% indicated they have experienced three or more miscarriages. For a device that’s effective, 15% of the respondents reported they did not achieve successful tubal occlusion. That 85% failure rate is a significant difference from the success rate reported during the clinical trials.

Almost 1,000 women, over 16% of our membership, women as young as 22 years old, have had major surgeries, usually a hysterectomy to remove the coils. In many instances, one surgery isn’t enough to repair all the damage. Many have endured multiple surgical procedures costing significant amounts of money. These multiple surgeries are usually to find errant coils which have ended up outside the fallopian tube. Essure may be the non-surgical alternative to a tubal ligation, but it is NOT going to keep someone out of the operating room.

The “lucky” ladies have coils expel into their uterus. For some women, doctors have retrieved coils from the vicinity of their liver, kidney, chest cavity, abdominal cavity and the lining of their stomach. One woman had an Essure coil migrate into her colon. She was required to have a colon resection due to the buildup of scar tissue. Her intestines also fused to her rectum. Despite this, Essure continues to be labeled and marketed as a form of birth control that is SAFE.

For the 84% of our group who have not been able to get the coils removed due to a lack of financial resources or the inability to find a surgeon willing to remove them, they suffer from the same debilitating side effects which led the other ladies in our group to the operating room.

Many of these women can attribute their issues to an allergic reaction to nickel, and an Essure coil is over 50% nickel. Nickel is a common allergen and a contraindication was included when the device was first marketed. The contraindication was removed from the label in 2011. The CEO of Conceptus explained the purpose of the new label was to further strengthen our competitive advantage and leadership in the permanent birth control market. In the same press release, he states that Conceptus will be aggressively marketing this change to the members of the OB/GYN community who won’t use our product “primarily because of potential nickel allergy in patients.” The motivation for this change was not based on patient safety but on the manufacturer’s financial interest. They did such a great job with their aggressive marketing that 82% of the respondents to our survey were not asked about any metal sensitivities. And the change in label led some doctors to believe that nickel had been completely removed from the product.

Women suffering from an allergic reaction live with constant pain, irritation and inflammation.

Women without a nickel allergy are also suffering with similar intense side effects which rob us of our health and a quality of life. We suffer with severe pelvic plain, headaches, joint pain and deterioration, chronic inflammation, extreme fatigue, severe bloating, skin conditions, irregular bleeding and many other side efforts. The side effects of Essure affect everyone in a family, not just the patient. Children grow up with a mom who is not healthy — who can’t lift and hug her child. Couples are robbed of their ability to have an intimate relationship because the act of making love is far too painful. Women post messages in our group contemplating suicide because of the pain caused by Essure. They are just so sick that being dead just seems like a better alternative. All of this for birth control; just birth control.

I leave you with two final stories. The first is a baby named Julius. He was conceived because, as with so many, Essure failed. Julius’ mom went into premature labor when an Essure coil perforated her amniotic sack causing her water to break. Julius was born alive, and his under-developed lungs couldn’t sustain him. Julius died on the day he was born, an innocent victim of a device you continue to say is safe and effective.

We learned about the women in the last story when an adverse event report was filed with the "United States Food and Drug Administration". While we don’t know her name, we know she was someone’s wife, mother and daughter. She had Essure and went to the emergency room complaining of abdominal pain. An exam found that her reproductive system, specifically her cervix, fallopian tubes and uterus were necrotic. In layman’s term, her organs were dead. She went into renal failure and did not recover. Her cause of death is listed as necrosis and toxic shock syndrome. The question of what caused her organs to die resulting in her death can’t be answered based on a report; however, it’s a coincidence that can’t be ignored.

Julius and the women in report number are dead. Will you still say this device is safe and effective?

On behalf of the 7,000 women who trust me to be their voice, and the women we have yet to hear from, we ask you, pull Essure from the market. I thank you for the opportunity to speak before you. Please do the right thing. Remove Essure from the market.

The Mom vs. Melinda Gates

This blog isn't only about me or Melinda Gates, its much bigger, its about a battle against the FDA and a defective birth control device called Essure. The Gates Foundation dispenses this product as part of their global contraceptive initiaive.

Michelle  

I'm a mom from Miami, Florida. This blog tells the story how I went from victim, to advocate to activist for women's birth control and against the FDA and a dangerous birth control device called Essure.

Erin Brockovich, Bayer and Essure horror stories

Bayer contraceptives : Sterilization with sideeffects

By Marc Pitzke, Spiegel online/New York

(AFP)  Consumer activist Erin Brockovich: "We seek dialogue with Bayer "

FiDA highlight/Google translation to English from German

 The legendary U.S. consumer activist Erin Brockovich has a new goal - the German Bayer AG. It's about their contraception Essure . Hundreds of women complain of some horrible side effects.

The gynecologist had promised: Everything would proceed entirely " pure and simple ". Two short, outpatient routine interventions , no anesthesia, done. So uncomplicated, the procedure let themselves almost at lunchtime do.

But after the first appointment, Michelle Garcia doubled in "excruciating pain " . After the second, it only got worse : Suddenly the otherwise dynamic woman was constantly tired , then the pain came back , and eventually she began to bleed uncontrollably hard.

"I almost died," the then 38 -year-old recalls. Fast: "I was lucky. "

What Garcia 2011 almost proved fatal, is in fact actually routine. The single mother from Miami did not want any more children and had therefore opted for the Essure procedure, the only permanent method of contraception without surgery. Two blocking coils are placed in the fallopian tube. " A quick, ten minute procedure in your doctor's office," says the manufacturer , Bayer HealthCare , a U.S. subsidiary of Bayer AG in New Jersey.

Been hundreds of horror stories on record

Michelle Garcia, however, is not the only one in the method went wrong. Hundreds of women have now given Essure horror stories on record, on blogs, websites, Twitter and their own Facebook group : chronic fatigue, depression, weight gain , Fibrositissyndrom , degenerative diseases , autoimmune disorders and menstrual disorders, migraine , allergic reactions, rash, dizziness, fever, unwanted pregnancies , miscarriages. Some of the coils are at least partially migrated through the body.

A petition, Essure " to stop or take this product off the market completely ," now contributes nearly 8000 signatures. The protesters also have prominent flank protection: The consumer activist Erin Brockovich - known by the eponymous film, the 2001 Oscar brought Julia Roberts - has done to their side.

"These women have no chance of recourse," Brockovich complains in an interview with SPIEGEL ONLINE . Since its legendary environmental struggle against U.S. power giant PG & E 20 years ago the infamous for their doggedness Ex - paralegal but has become more circumspect. Cooperation instead of war: "We seek dialogue with Bayer. "

But so far, let Bayer rebuffed them. Therefore Garcia and Angela Lynch travel, one of her fellow-sufferers, now to Germany to confront Supervisory Board Chairman Werner Wenning and the Chief Executive Officer Marijn Dekkers at the Bayer Annual General Meeting on Tuesday in Cologne directly. At the invitation of the activist group Coalition against Bayer Dangers Garcia wants to step up to the microphone there.

Bayer, the problem has indeed saddled probably unintentionally, as it bought up the Essure Conceptus manufacturer last year for $ 1.1 billion. "Bayer and Conceptus have the goal with innovations to promote the health of women," rejoiced Andreas Fibig, the CEO of Bayer HealthCare Pharmaceuticals, still there.

"I do not want others to have to join the same "

"Anyone who feels pain or complications, for whatever reason, our great compassion ," said Edio Zampaglione, Vice President of U.S. Medical Affairs at Bayer winds . Bayer debt wear but no: "There is no birth control method that is one hundred percent effective, and which is also clear in our leaflet. "

Derlei " adverse events," said Zampaglione continued, were also " in clinical trials " and a study by the U.S. Pharmacopeia Drug Administration (FDA?) has already been observed and recognized from the beginning. The turn keeps these side effects for infrequent: Essure is " effective as a means of permanent sterilization to 99.83 percent."

Michelle Garcia took their claims to only five months to find out that their pain decreased on Essure. It turned out, therefore, that a coil broken and had wandered in Garcia's abdomen. Both coils should be removed surgically.

Garcia started in a support group to get involved, which now has more than 7,000 members: "I do not want others must join the same." They also sent in 2013 a long letter to Bayer CEO Dekkers, investor relations chief Alexander Rosar and spokeswoman Tricia McKernan . "Women suffer unspeakable pain and serious discomfort, which they got after Essure was implanted," she wrote and warned Bayer. " You now have a nightmare " One answer they never got.

Why are they now pilgrimage to Cologne, " in the lion's den," she says. For their big entrance at Tuesday Garcia has even trained with a coach public speaking because German language was required: " The women rely on my voice. "

Bayer-Verhütungsmittel: Sterilisation mit Nebenwirkungen

Von Marc Pitzke, New York   (Original German)

Die legendäre US-Verbraucheraktivistin Erin Brockovich hat ein neues Ziel - die deutsche Bayer AG. Es geht um deren Verhütungsmittel Essure. Hunderte Frauen klagen über teils grausige Nebenwirkungen.

AFP

Verbraucheraktivistin Erin Brockovich: "Wir suchen den Dialog mit Bayer"

Der Gynäkologe hatte es versprochen: Alles würde ganz "einfach und simpel" verlaufen. Zwei kurze, ambulante Routine-Eingriffe, keine Narkose, fertig. So unkompliziert, die Prozedur lasse sich quasi in der Mittagspause erledigen.

Doch schon nach dem ersten Termin krümmte sich Michelle Garcia unter "qualvollen Schmerzen". Nach dem zweiten wurde es nur noch schlimmer: Auf einmal war die sonst so dynamische Frau dauernd todmüde, dann kamen die Schmerzen zurück, und schließlich begann sie, unkontrollierbar schwer zu bluten.

"Ich wäre fast gestorben", erinnert sich die damals 38-Jährige. Fast: "Ich hatte Glück."

Was Garcia 2011 beinahe zum Verhängnis wurde, ist in der Tat eigentlich Routine. Die alleinstehende Mutter aus Miami wollte keine Kinder mehr und hatte sich deshalb für das Essure-Verfahren entschieden, die einzig dauerhafte Methode der Empfängnisverhütung ohne Operation. Dabei werden zwei Blockade-Spulen in die Eileiter gesetzt. "Eine schnelle, zehnminütige Prozedur in Ihrer Arztpraxis", versichert der Hersteller Bayer HealthCare, eine US-Tochter der Bayer AG in New Jersey.

Hunderte Horrorstorys zu Protokoll gegeben

Michelle Garcia ist aber nicht die Einzige, bei der die Methode schiefging. Hunderte Frauen haben inzwischen Essure-Horrorstorys zu Protokoll gegeben, auf Blogs, Websites, Twitter und in einer eigenen Facebook-Gruppe: chronische Müdigkeit, Depressionen, Gewichtszunahme, Fibrositissyndrom, Degenerationskrankheiten, Autoimmun- und Menstruationsstörungen, Migräne, allergische Reaktionen, Ausschlag, Schwindelgefühle, Fieber, ungewollte Schwangerschaften, Fehlgeburten. Bei einigen seien die Spulen zumindest teilweise durch den Körper gewandert.

Eine Petition, Essure "zu stoppen oder dieses Produkt ganz vom Markt zu nehmen", trägt mittlerweile fast 8000 Unterschriften. Die Protestler haben außerdem prominenten Flankenschutz: Die Verbraucheraktivistin Erin Brockovich - bekannt durch den gleichnamigen Film, der Julia Roberts 2001 einen Oscar brachte - hat sich auf ihre Seite geschlagen.

"Diese Frauen haben keinerlei Aussichten auf Regress", klagt Brockovich im Gespräch mit SPIEGEL ONLINE. Seit ihrem legendären Umweltkampf gegen den US-Stromriesen PG&E vor 20 Jahren ist die für ihre Verbissenheit berüchtigte Ex-Anwaltsgehilfin aber bedächtiger geworden. Kooperation statt Krieg: "Wir suchen den Dialog mit Bayer."

Doch bisher ließ Bayer sie abblitzen. Deshalb reisen Garcia und Angela Lynch, eine ihrer Leidensgenossinnen, jetzt nach Deutschland, um Aufsichtsratschef Werner Wenning und den Vorstandsvorsitzenden Marijn Dekkers bei der Bayer-Hauptversammlung am Dienstag in Köln direkt zu konfrontieren. Auf Einladung der Aktivistengruppe Coordination gegen Bayer-Gefahren will Garcia dort ans Mikrofon treten.

Bayer hat sich das Problem ja auch eher ungewollt aufgehalst, als es den Essure-Hersteller Conceptus im vergangenen Jahr für 1,1 Milliarden Dollar aufkaufte. "Bayer und Conceptus haben das Ziel, mit Innovationen die Gesundheit von Frauen zu fördern", freute sich Andreas Fibig, der Vorstandschef von Bayer HealthCare Pharmaceuticals, da noch.

"Ich will nicht, dass andere das Gleiche mitmachen müssen"

"Jeder, der Schmerzen oder Komplikationen empfindet, egal aus welchem Grund, hat unser großes Mitgefühl", windet sich Edio Zampaglione, Vice President US Medical Affairs bei Bayer. Schuld trage Bayer aber keine: "Es gibt keine Verhütungsmethode, die hundertprozentig effektiv ist, und das steht auch klar auf unserem Beipackzettel."

Derlei "unerwünschte Ereignisse", so Zampaglione weiter, seien außerdem "in klinischen Tests" und einer Studie der US-Arzneibehörde FDA schon von Anfang an beobachtet und anerkannt worden. Die wiederum hält diese Nebenwirkungen für selten: Essure sei "als Mittel zur permanenten Sterilisierung zu 99,83 Prozent effektiv".

ANZEIGE

Michelle Garcia brauchte ihren Angaben zufolge allein fünf Monate, um herauszufinden, dass ihre Pein auf Essure zurückging. Es stellte sich demnach heraus, dass eine Spule zerbrochen und in Garcias Bauchraum gewandert war. Beide Spulen sollen operativ entfernt worden sein.

Garcia begann sich in einer Hilfsgruppe zu engagieren, die inzwischen mehr als 7000 Mitglieder hat: "Ich will nicht, dass andere das Gleiche mitmachen müssen." Auch schickte sie schon 2013 einen langen Brief an Bayer-Chef Dekkers, Investor-Relations-Chef Alexander Rosar und Sprecherin Tricia McKernan. "Frauen erleiden unsägliche Schmerzen und ernsthafte Beschwerden, die sie bekamen, nachdem Essure implantiert wurde", schrieb sie und warnte Bayer: "Sie besitzen jetzt einen Alptraum." Eine Antwort bekam sie nie.

Weshalb sie nun nach Köln pilgert, "in die Höhle des Löwen", wie sie sagt. Für ihren großen Aufritt am Dienstag hat Garcia sogar mit einem Coach öffentliches Reden trainiert: "Die Frauen verlassen sich auf meine Stimme."

Essure: Hazardous Birth Control Implant?

Warning: This Birth Control ProductMay Be Hazardous to Your Health

Posted: 11/19/2013 1:36 pm

 by guest blogger Diana Zuckerman, PhD, president of the National Research Center for Women & Families

"Was I just unlucky, or is this medical product not really safe?" That's a question I get asked often, and was recently asked about Essure, a "permanent birth control" device made by Bayer.

At first it seemed these women were just unlucky. But after gathering more information, it now looks like there could be much greater risks than patients are being advised of.

In case you're wondering, permanent birth control means sterilization. The purpose of Essure is to prevent a woman from ever getting pregnant again. For some women, preventing any future pregnancies could save their lives. So it is obviously a problem when Essure doesn't work and women get pregnant, which was one of the problems I heard about. But I also heard from women who were in terrible, unrelenting pain, feeling that their lives had been ruined by this product.

Since National Research Center for Women and Families is known as an objective source of medical information and isn't on the payroll of any companies, the women asked, "What do you know?" and "Is this product really safe, or are there a lot of other women like me?" And also, "Can you warn other women?"

The Food and Drug Administration (FDA) has much lower standards for medical implants than it does for prescription drugs, so I checked out Essure on the FDA website and was pleasantly surprised to see that the FDA had required clinical trials, which the agency often doesn't require for implants. These studies of women with Essure implants showed that Essure patients had a rather low rate of complications.

The studies showed that the main problem was that sometimes the device fell out. If the woman didn't realize it, she could get pregnant. If she did realize it, she'd need to get a replacement implant or use another type of birth control.

There was about a 5 percent rate of serious complications reported--not great (especially if a complication happens to somebody we care about), but not a bad rate, either. Since all birth control has some risks (such as potentially fatal blood clots), and since pregnancy has rather substantial health risks (an even greater risk of potentially fatal blood clots), the studies of Essure seemed reassuring (no pun intended).

Sometimes studies can be deceiving, however, especially when conducted by the company trying to sell you the product. An NBC news investigative team interviewed Kim Hudak, one of the women in the study who has had terrible pain in the years since she got Essure. The reporters found that the telephone surveys and medical visits that were used to provide data for the company's study had yielded information about her terrible health problems after Essure but hadn't counted them as complications. The health professionals conducting the study had made very subjective decisions: for example, that excruciating pain in the same part of her body as the Essure device somehow was unrelated to Essure and therefore needn't be counted as a complication. Instead, they reported Kim's experience with Essure as "excellent" and Kim as "very satisfied." Meanwhile, Kim was in excruciating pain--and had gained 100 pounds from the medications she was given as doctors tried to figure out what was wrong. Kim told me that she thought her health problems might possibly be caused by Essure but believed the doctor when he told her they weren't.

Eventually, Kim was in so much pain that she ignored the doctor's advice and had her Essure implant removed. Kim told me that her health has dramatically improved ever since, and she has lost most of the weight she had gained.

This is not the story of one woman. It's a story about how poorly conducted research provides inaccurate information that can potentially harm thousands if not millions of patients. Whether the study was intentionally fraudulent or just badly conducted by some of the medical professionals involved, the results are the same for Kim and anyone misled by the completely inaccurate reporting of her terrible medical problems. The fact that Bayer was accused just two years ago of covering up deaths from Yasmin, another one of its birth control products, does add extra drama. Can the company's studies be trusted? And should the FDA do a better job of scrutinizing them?

It doesn't take much to monitor these studies. For example, you can see in Kim's study survey where her health problems were clearly written and then somebody crossed them out, added his or her initials to show this was an official revision, and changed the answer from "Yes" (I have health problems since getting Essure) to "No." The woman interviewing Kim also checked "excellent" and "very satisfied."

If that had only happened to Kim and nobody else, then perhaps Essure could be almost as safe as the company reported. But the same people who collected data on Kim also "studied" other women, so it's likely that such changes and inaccuracies happened numerous times. That would mean that FDA's decision to approve Essure was based on inaccurate information.

Instead of monitoring the company's studies, unfortunately, the FDA has defended them. While the NBC investigative reporters were gathering information, the FDA wrote a new article for its website defending the safety of Essure.

As a person who uses medical products, what can you do to make sure you aren't harmed by implants or medications that aren't really safe? There is no easy answer. But there are a few things you can do:

.                Before starting a new medication or agreeing to a new medical implant or device, go online. Go to your favorite search engine and type in the name of the product and the word "problems" or "risks" or "complications." That will usually take you to web pages that list the possible problems with the product. You can even go to the official website for the product. Although a company's website will advertise how great the product is, by law the company is also required to list all the possible complications that the FDA has found. This isn't a perfect source of information (as my Essure example shows), but it will provide some warnings of what the risks are.

.                For prescription drugs, you can also go the ConsumerReport.org's Best Buy Drugs website to get information that compares the drug you are considering with other drugs that can be used for the same purpose. The site doesn't have information about all drugs, but it does have good comparison information about many widely used drugs.

.                Check out www.center4research.org and www.stopcancerfund.org for information about many drugs and devices. And, if you are having trouble finding the information you're looking for, you can contact our Center's free hotline at info@center4research.org to ask us. You'll receive a free, personal response within days.

One more thing to remember: The newest medical products are often not the best, even though they're the most expensive. FDA approves new medical products on the basis of information that is provided by the company making the product. It isn't until the product has been used by many thousands of patients in the real world that it's possible to learn what all the risks are and how it compares to other treatments.

Diana Zuckerman is the president of the National Research Center for Women & Families. She received her PhD from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House. She is the author of five books, several book chapters, and dozens of articles in medical and academic journals as well as in newspapers across the country.