How the FDA Works

I wish I could tell you speaking out about mesh implants in front of the FDA will make one bit of difference to that panel and any changes they make about how mesh implants are used. The warnings they put out are still not stopping the flow of injured women because doctor’s voices are very strong indeed because they are paid well by the manufacturing companies. I believe the FDA only works by the numbers of complications when they are reported, before a new warning takes place. Sometimes it takes many years for the numbers to be high enough to publish a new warning. That is why I encourage EVERY woman to report her symptoms and complications to the FDA once they believe it is mesh complications. I don’t think standing in front of the FDA panel helps much at all, because these people don’t really care. Yes they will allow lip service from anyone, but do they pay that much attention to what is happening to women? I doubt it. I do have reasons for feeling they won’t remove mesh implants from the market. It is because they rarely remove a drug from the market and this will explain more. First what about implants?

FDA to require “black box” warning, but leaves controversial Essure implant on market

February 29

The Food and Drug Administration said Monday that it will require German drug maker Bayer AG to undertake new safety studies on its permanent birth-control device Essure, after thousands of women complained about suffering complications from the controversial implant. The agency also plans to require a “black box” label warning about the device’s potentially serious side effects, plus a checklist for doctors to discuss potential risks with patients.

“The agency has carefully reviewed all the available evidence … While there are risks associated with the use of Essure, there are also benefits,” William Maisel, chief scientist at FDA’s Center for Devices and Radiological Health, said in a call with reporters Monday. “We believe informed women should have this as an option available to them.”

The agency’s decision Monday drew immediate criticism from at least one lawmaker of each party on Capitol Hill, as well as from a community of women who have said the device caused devastating health problems — including pelvic pain, stomach swelling, dizziness, cramping, bleeding and fatigue. They have waged a relentless social media campaign to have Essure pulled from the market.

“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and [to] ask the manufacturer to perform another study while leaving Essure on the market,” Rep. Mike Fitzpatrick (R-Pa.), who has pushed the agency to halt the device’s use, said in a statement Monday. Rep. Rosa DeLauro (D-Conn.) agreed, saying the agency must make sure the company does the follow-up studies and that “Essure should be off the market until the requested studies are completed.”

A Facebook group called Essure Problems, which has thousands of female members who have shared stories about health problems they experienced after receiving the device, said Monday it was “outraged” by the agency’s decision.

“These studies could take several years, and leaving the device on the market will only put more women’s lives at risk,” the group said in a statement, which also questioned why the agency would allow Bayer itself to conduct safety studies of Essure. “We are disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device.”

[FDA to review safety of controversial women’s sterilization device]

Bayer has maintained that Essure, which the FDA approved in 2002, has a solid safety record and should remain available as an option to women seeking permanent birth control. The company vowed to work with the FDA to put the agency’s recommendations in place.

“Patient safety and appropriate use of Essure are our greatest priorities,” Dario Mirski, senior vice president and head of medical affairs Americas at Bayer, said in a statement. “A woman’s decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure.”

The device itself is little more than a small, flexible coil made in part from an alloy of nickel and titanium. A doctor inserts a coil through the cervix and into each Fallopian tube, in a procedure that typically takes less than 15 minutes. Over roughly three months, tissue is supposed to form around the inserts, blocking the tubes and preventing pregnancy. During that initial period, women must use alternative forms of birth control.

The FDA held a much-anticipated public meeting on Essure last fall amid growing reports of complications. The women who spoke detailed harms they attributed to the device, including unplanned pregnancies when it failed and surgeries to remove it after suffering painful side effects. On Monday, Maisel said that among the thousands of reports the FDA had received about Essure, there were 631 reports of women becoming pregnant after receiving an Essure implant; of those, 294 included pregnancy loss. Still, he said, the device overall had proven “extremely effective at preventing pregnancies.”

Bayer, which is facing several lawsuits over Essure, has insisted the device is 99 percent effective when inserted properly and when women use birth control until a follow-up visit several months after the procedure. The company says about 1 million of the devices have been sold worldwide, the vast majority of them in the United States, and that complications happen in only a small fraction of patients.

“Clearly, the data for Essure shows the benefits outweigh the risks,” Edio Zampaglione, the company’s vice president of medical affairs for women’s health, told The Post in an interview last year. “There’s nothing [we’ve seen] with the product itself that says we’ve got a defective product or something that needs to be taken off the market.”

So what about drugs? You may think a drug is pulled quickly off the market when there are deaths. However, sometimes it will take many years and more deaths are reported. Now you can learn more.

There are 35 drugs we could find that have been recalled from the US market since the 1970s, some that had been in use since the 1930s. A sample of advertisements for only some of the drugs are included because there is a scarcity of ads for withdrawn drugs online due to manufacturers removing ads for withdrawn drugs as part of the agreement to no longer market the drugs.

According to the FDA, a “drug is removed from the market when its risks outweigh its benefits. A drug is usually taken off the market because of safety issues with the drug that cannot be corrected, such as when it is discovered that the drug can cause serious side effects that were not known at the time of approval.” The FDA also takes into account the number of people taking a drug being considered for removal so as to not harm those patients.

The last sentence tells you that reporting your complications is vitally important. You will be shocked when you read just how long some drugs were on the market before they were removed and you may recognize one you took. So here are the first two on the list of thirty-five drugs removed from market.

Isotretinoin (marketed as Accutane) Capsule Information.

This drug was on the market for 27 years from 1982 to 2009. Why was it on the market that long? Most of the time symptoms from things we take are marred by other illnesses and it take a long time to put two and two together. Even then drug complications go UNDER-REPORTED.

Cause for recall:

increased risk of birth defects, miscarriages, and premature births when used by pregnant women; inflammatory bowel disease; suicidal tendencies

Over 7,000 lawsuits were filed against the manufacturer over the side effects including a $10.5 million verdict and two $9 million verdicts.

FDA ALERT [7/2005]: Suicidal Thoughts or Actions: In addition to the strengthened risk management program, FDA continues to assess reports of suicide or suicide attempts associated with the use of isotretinoin. All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression. Patients should stop isotretinoin and they or their caregiver should contact their healthcare professional right away if the patient has any of the previously mentioned symptoms. Discontinuation of treatment may be insufficient and further evaluation may be necessary. [Action taken 8/12/2005 Labeling revision]

Isotretinoin is marketed under these names:

  • Accutane
  • Amnesteem
  • Claravis
  • Sotret

The second drug almost took my sister’s life in England. She was only on this drug three months and during that time I could not fly to see her because my husband was having prostate cancer treatment. But I knew something was seriously wrong with my sister when I spoke to her over the phone. Thank God she finally realized it and stopped taking this drug.

Baycol (cerivastatin sodium tablets) 1998 to Aug 2001.

This drug was only on the market for 3 years and it killed 52 people.

Audience: Health Professionals and Consumers

Bayer announced the withdrawal of all dosages of its cholesterol-lowering drug with the brand names Baycol/Lipobay (active ingredient: cerivastatin), due to increasing reports of side effects involving muscular weakness (rhabdomyolysis). Fatal rhabdomyolysis associated with Baycol have been reported most frequently when used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (LOPID and generics), another lipid lowering drug.

[August 08, 2001 – Letter – Bayer] You can download the letter to read what was sent out.

Cause for recall:

rhabdomyolysis (breakdown of muscle fibers that results in myoglobin being released into the bloodstream) which led to kidney failure; 52 deaths (31 in the US) worldwide; 385 nonfatal cases with most requiring hospitalization; 12 of the deaths were related to taking this drug in combination with gemfibrozil (Lopid)

My sister had the muscle breakdown and to this day, she still suffers and has to live her life dealing with the consequences of this drug. She tried to find a lawyer in England to take her case, but when you live anywhere else in the world other than the U.S, lawyers rarely take these cases and they are NOT on a contingency basis. So she could not afford to hire one.

The following drug I have already written about on this blog. I was quite shocked when I learned about this from a mesh injured woman.

Diethylstilbestrol (DES) is an estrogen that was first manufactured in a laboratory in 1938, so it is called a “synthetic estrogen.” During 1938-1971, U.S. physicians prescribed DES to pregnant women to prevent miscarriages and avoid other pregnancy problems. As a result, an estimated 5-10 million pregnant women and the children born of these pregnancies were exposed to DES. Physicians prescribed DES to pregnant women on the theory that miscarriages and premature births occurred because some pregnant women did not produce enough estrogen naturally. At the time, physicians thought DES was safe and would prevent miscarriages and pre-term (early) births.

Use: synthetic estrogen to prevent miscarriage, premature labor, and other pregnancy complications Manufacturer: Grant Chemical Co

Cause for recall:

clear cell adenocarcinoma (cancer of the cervix and vagina), birth defects, and other developmental abnormalities in children born to women who took the drug while pregnant; increased risk of breast cancer, higher risk of death from breast cancer; risk of cancer in children of mothers taking the drug including raised risk of breast cancer after age 40; increased risk of fertility and pregnancy complications, early menopause, testicular abnormalities; potential risks for third generation children (the grandchildren of women who took the drug) but they are unclear as studies are just beginning. Studies in the 1950s showed the drug was not effective at preventing miscarriages, premature labor, or other pregnancy complications.

I found out that other women had been given this drug, or their mothers took it, so I wrote this blog

You can read more about how to report to the FDA here

My focus shifted when I realized that the FDA will undoubtedly leave these implants on the market forever, to raising awareness one woman at a time, by giving women information before they go for any surgery where an implant could be used. I doubt if there will be any changes to stop the use of mesh implants for many, many years if ever. This is also why I continue to ask women to report their complications to the FDA and explain exactly what those symptoms are. I have also written blogs about other drugs especially the side effects of pain medications. If you want to know about the other drugs are on this list, go to this site

So what does the government in Great Britain say?

Dr Susanne Ludgate, Clinical Director for Medical Devices at the MHRA, said:

“We listened to and understand the concerns that many women have about vaginal tapes and meshes. That is why we commissioned research to review the available literature on the safety and adverse effects associated with these products. Whilst a small number of women have experienced distressing effects, the current evidence shows that when these products are used correctly they can help with the very distressing symptoms of these conditions and as such the benefits still outweigh the risks.”

The Department continues to work closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to make sure that surgery using these products is as safe as possible. The MHRA continues to closely monitor the performance of these medical devices and are working closely with the European Commission on their proposed improvements to the European-system of regulation applying to medical devices generally.

The MHRA, working with the professional associations, has also developed information for women who are considering this procedure or who are experiencing a problem with an implant.

Unless women speak out loudly and report their complications, what has happened to some women are being dismissed. This is that link

Leave a Comment

Your email address will not be published. Required fields are marked *