For a while there has been some controversy around the processes that medical devices go through to be approved, such as the accusation that theyre released to the public by FDA with little to no evidence that they work or are safe for use.

One device that brought it up was Essure - when it came out, it was advertised as a miracle: A minimally invasive procedure that requires no cutting, leaves no visible scars, and can be performed in your doctor’s office. Its a permanent birth control method, basically a little insert placed in the Fallopian tubes. With time, your body will start to build a scar tissue around it, and form a barrier in probably 3 months.

However, it was released after only two years of a clinical trial with only 73 women, and apparently no one took into consideration (or didnt want to) that women would use this device for a lifetime, not only 2 years. (ClinicalTrials.gov Identifier: NCT01861886)

Not long after it started to be used, multiple reports were made to FDA and Bayer company. Among the complications, some were fallopian tube perforations, unintended pregnancies, autoimmune symptoms, and severe pain and bleeding that have resulted in hysterectomies - more than 15,000 women have filed lawsuits against them.

Another device that have been getting controversial criticism is the Da Vinci Robot, used for cholecystectomy, hysterectomy, prostatectomy (removal of gallblader, uterus and prostate), and many other open and laparoscopic surgeries, which is minimally invasive, reduce blood loss and promotes a faster postop recovery. After a few years, the number of death and complications increased, mostly to lack of training to use it but some also for malfunction of the device. There has been some debates if the spike of complications is hapenning due to increased use.

Do you think that Ensure is just an exception? How much do you trust FDA regulations on medical devices?