The Bleeding Edge

is a remarkable film investigating the public health crisis caused by our current medical device industry. It examines the two main causes permitting the manufacture and sale of defective medical devices: corporate greed and inadequate FDA oversight. It is a tragic story, particularly when the film takes a close look at many of the actual victims of these harmful medical devices. It’s one thing to hear that the Essure birth control device has injured thousands of women; it’s quite another when you see a woman on screen explain how she has given up on her hope to find love because she can no longer have intercourse due to permanent internal injuries. It is deeply sad to hear these stories. And it may have you writing your member of congress. Which you should.

I urge you to check out the film. Here are a few key takeaways:

Medical Device Regulation and the FDA

The 1976 Medical Device Amendments Act (“MDA”) was a positive step forward for regulating medical devices and for protecting human health. However, over the years certain loopholes in the MDA have allowed medical device companies to run amuck. The worst of these loopholes is the 510(k) process, which I have written about extensively on this site. Under 510(k), a medical device company may avoid clinical testing and the “Pre-Market Approval” process if the company can show that the new device is “substantially equivalent” to a similar device already approved and on the market. This may sound benign–after all the products are equivalent–but it has allowed many inadequately tested and dangerous devices to hit the market. One of the best examples of this 510(k) failure is the metal-on-metal (MoM) artificial hip. Because the MoM hip was “substantially equivalent” to previous artificial hip systems, the FDA permitted several device companies to manufacture and sell MoM artificial hips. Turns out, in many cases the MoM construction allowed metals to grind and be released into the blood and tissue of patients, causing all kinds of problems, from severe leg pain to neurological symptoms. Check out this site for many articles on the MoM artificial hip.

According to The Bleeding Edge, in some cases a new medical device is approved under 510(k) because of its substantial equivalence to an existing product that has been recalled because of health concerns. The FDA has explained that, under 510(k), it does not look at the safety of the underlying medical device; rather, it simply examines whether the new product is “substantially equivalent” to the predicate product. If this sounds loony, then you are paying attention. As a former FDA commissioner noted in the documentary, “we built a system that doesn’t work.”

Dr. Stephen Tower and Metal-on-Metal Artificial Hips

If you have had a metal-on-metal artificial hip implanted, you should know the name Stephen Tower. Dr. Tower is an orthopedic surgeon who figures prominently in The Bleeding Edge. And he deserves the screen time. I first wrote about Dr. Tower in 2017 after I discovered a lecture he had given on the potential for neurological problems associated with increased cobalt levels caused by metal-on-metal artificial hips. Dr. Tower is in a unique position as a hip surgeon but also as a victim of a MoM hip replacement, the DePuy ASR MoM hip. After his hip replacement surgery, he suffered memory loss, ringing in his ears, tremors, and mood swings. He even trashed a hotel room. Dr. Tower discovered that the metal levels in his blood were causing these neurological symptoms. After revision surgery, his metal levels dropped and his symptoms disappeared.

The documentary looks at several of these harmful medical devices, from artificial hips to hernia mesh to the Essure birth control device. More importantly, it takes a long look at several of the victims of these devices. The human suffering is intense and hard to watch, but it is vitally important to see it.

What Should You Do If Facing a Medical Device Implant Surgery?

At the end of the film the producers list a few smart moves you should make if your doctor has advised you to have a medical device implanted:

1. Do your research on the device. Distrust the “newest innovation.” As Dr. Tower said, innovation is not always a good thing.
2. Get a second opinion. Trust me, this is a good idea. And you may be surprised how different is the opinion of the surgeon a mile up the street from your treating surgeon.
3. Ask your surgeon how many times he or she had done the surgery. In some surgeries, like the Smith & Nephew hip resurfacing technique, the surgeon is expected to practice the procedure hundreds of times before he or she performs the surgery on patients. Often doctors begin these procedures after just a few practice sessions. Which is scary.
4. Take a friend or family member with you to the hospital. Have them pay attention and advocate for you.
5. Find out whether your doctor was ever paid directly by a medical device company at openpaymentdata.cms.gov.

Disclaimer (However Mild)

The Bleeding Edge presents the medical device industry in a sharply critical light. The documentary “takes a position,” and the position is that for-profit corporations who develop and manufacture medical devices often push these devices into the market without adequate testing and guided too often by a profit motive. I happen to agree with this position. However, it’s no surprise that medical device companies have been pushing back on the film’s allegations. Bayer, for example, maker of Essure, “fact checks” The Bleeding Edge on its website. I encourage you to check it out it if you would like to read the company’s response to the documentary.

If you want to discuss The Bleeding Edge, or if you have a medical device that has caused you problems, give me call: (919) 830-5602.

Bayer’s Essure birth control device is coming off the market, thanks to a public campaign aimed at raising awareness about its dangers. After years of silence, in which women were told that their pain wasn’t real, and years of incident reports that went unheeded, the U.S. Food and Drug Administration (FDA) finally agreed that Bayer needed to do more to warn patients about the risks of the birth control device.

Now that women are making informed decisions, use of the birth control device has dropped off so precipitously that Bayer is ending its production. Let’s look at what Essure is and why it’s so dangerous.

The Essure Birth Control Implant

The Essure birth control implant is actually two implants, each a narrow coil of metal and fiber that must be inserted in the fallopian tubes. For three months or so after the implants are inserted, scar tissue grows around the devices, permanently closing the fallopian tubes and—at least in theory—preventing sperm from reaching the eggs.

Essure is a permanent form of birth control that cannot be removed. The coils essentially become part of the patient’s body, encased in her own scar tissue. As Bayer describes it, Essure results in irreversible female sterilization.

The FDA approved the device in 2002. At first, all seemed to be well. Essure doesn’t involve any drugs or artificial hormones. The procedure requires no incision or, usually, anesthesia. It’s a walk-in, walk-out appointment that takes about 30 minutes. Sounds great, right?

Wrong.

Problems With the Birth Control Implant

In the last few years, the FDA finally noticed “the growing number of adverse event reports” from women with Essure implants. Those reports included serious, life-threatening symptoms:

• persistent and significant pain;
• punctures to the uterus and fallopian tubes;
• movement of the implant into other areas of the body, including the abdomen and pelvis;
• bleeding;
• allergic reactions; and
• deaths.

Women seeking removal of their Essure devices have needed painful surgery—whether the devices were still where they were placed or had migrated elsewhere.

In addition, a few women with the implants nonetheless became pregnant, sometimes with catastrophic results. The FDA states that it received 26,773 medical device reports related to Essure between its approval in November 2002 and the end of 2017. In that time, there were 40 reported deaths. While eight of those deaths were of adults, the majority were infants who died during pregnancy.

The FDA assembled an expert panel to evaluate these safety concerns and the extent of the warnings that doctors were giving to potential patients. In October 2016, it required a new warning on the device label and created a “Patient Decision Checklist” to help women considering Essure implants make informed decisions about the risks.

These efforts to counsel patients about the risks had a huge impact: since the increased warnings, Bayer has seen a 70 percent decline in Essure sales in the U.S.

But in April 2018, the FDA realized that “some women were not being adequately informed of Essure’s risks … despite previous significant efforts.” Clearly, while more women were rejecting the devices, women were still getting this permanent implant without ever hearing about its risks. Therefore, the FDA imposed a restriction limiting Essure sales to facilities that agreed to counsel patients and use a signed acknowledgment form.

Shortly after that, things got even worse for Bayer’s attempts to promote this dangerous device.

The Public Campaign About Essure’s Dangers

Essure isn’t, of course, the only dangerous implant; medical devices of all types are often under-regulated and risky. Fortunately, the word is getting out about those dangers. In July 2018, Netflix released a documentary called The Bleeding Edge that discussed five medical devices, including Essure, and the often unmentioned risks associated with them.

Just before the release date for The Bleeding Edge, Bayer announced that it was taking Essure off the market at the end of 2018—but not because it was causing harm to patients. Rather, Bayer pulled the device as a “business decision” because it is no longer generating enough profit. In its announcement, Bayer blamed, in part, “inaccurate and misleading publicity about the device” for those declining sales. Bayer firmly stated that it “continue[s] to stand behind” the safety of the birth control device.

But with a device that literally becomes part of the patient’s body, ending sales doesn’t do anything to help women who already have the permanent implants. The FDA was careful to announce that “postmarket safety … will continue to be a top priority.”

As of now, around 16,800 lawsuits have been filed against Bayer for problems related to Essure implants. Bayer reports that “additional lawsuits are anticipated.”

Have you had problems with an Essure implant or another medical device? Let’s discuss your options. Call me at (919) 830-5602.