Medical Devices, How much can we trust the FDA?

The medical device industry is a 400 billion dollar powerhouse and has been known to have big profit-oriented stockholders. Sadly, with the financial mindset, dysfunctional devices have slipped through the FDA and affected many individuals in negative ways. In 2018 "Bleeding Edge", a documentary was released on Netflix explores multiple devices and the people who received them. Multiple women and their complications with medical devices approved by the FDA came with life-changing consequences including; infertility, emergency surgeries, and loss of the ability to have intercourse. The medical devices being assessed in the film: Bayer's permanent birth control device Essure, vaginal mesh, the Da Vinci Surgical System, and chrome-cobalt hip-replacements. The purpose of the film was to encourage further testing before products are released on the market, and like other countries, remove the dangerous ones when people speak out against them.

The device Essure has not been removed from the market, but as of 2020, Bayer had agreed to pay a 1.6 billion dollar settlement for the nearly 39,000 claims. The majority of the complaints were; Hysterectomy, pain, bleeding, nickel sensitivity, unwanted pregnancy, weight gain, autoimmune disorders, and perforation. In defense, Bayer used a legal defense called preemption, since the FDA approved Essure at the federal level, it gave Bayer protection from claims that the company failed to warn the public of risks.  As of 2020 all complaints and faulty reports are still voluntary, and like many women claim in the documentary, the technicalities about if the device is faulty or not can determine what the data says. If you were to receive Essure permanent birth control and DIDNT get pregnant but an injury had occurred, then in the eyes of Bayer, the device itself wasn't a fail. In addition to the malpractice of Bayer, according to the journal of gynecology, Bayer tried to “shift blame to the gynecologist to absolve itself of liability” (2019). 

    As future physicians, how can we interpret the FDA's data if there have been issues pointed out by the public. How do you protect yourself and your patients when you choose to treat them? In the documentary, some doctors were clueless about the pain they had caused patients due to their full trust in the FDA. I wonder if it is possible to justify your treatments outside of the FDA regulations and approval, to do this, how much time would you have to put in towards research?  It is important to acquire the skills to decipher through the overwhelming amount of information available to us, especially for our generation of doctors entering the world where [a guess to] an answer is a simple google search away. Ultimately, I think it comes down to the importance of reporting faulty medical devices as our commitment to beneficence, and encouraging integrity in the statistics being reported to the FDA. 

Here is a video of FDA, CEO talking about Essure and other devices and why they are still on the market due to preemption:

https://www.drugwatch.com/essure/lawsuits/#:~:text=Former%20FDA%20program%20manager%20Madris%20Tomes%20highlights%20the%20devices%2C%20including%20Essure%2C%20that%20are%20still%20on%20the%20market%20due%20to%20FDA%20preemption.

Dick, Kirby, 'Bleeding Edge' Netflix Original (2018)

Llamas, Michelle, Essure Lawsuits, (2020)https://www.drugwatch.com/essure/lawsuits/

Evaluating Antiseizure Medication in Pregnancy

In the not too distant past, women with epilepsy were discouraged from getting pregnant because uncontrolled seizures can harm both the mother and developing baby. In fact, prior to the 1960s, not only were women with epilepsy advised not to get pregnant, many states had laws prohibiting individuals with epilepsy from getting married. The development of anti-seizure medications as well as changes in societal views in the 60s and 70s led to a loosening of these recommendations/laws. These older anti-seizure drugs, such as valproate, unfortunately were found to increase the risk of birth defects. However, the newest generation of anti-seizure drugs are safer to use during pregnancy and breastfeeding according the results of a new study published in JAMA Neurology. Researchers measured verbal abilities at age 2 in nearly 300 children whose mothers took newer medications for epilepsy. Their children had equal language development to those in a control group, along with moderate risks in other areas for children exposed to the highest levels of the medications before birth. The findings indicate that cognitive risks of the newer drugs are smaller than for valproate treatment as a prior study found a loss of 10-12 IQ points in children exposed to valproate in utero. These results suggest that proper administration of newer medications, and monitoring of doses to stop seizure activity, can help increase normal pregnancy outcomes in women with epilepsy.