Bayer’s Controversial Contraceptive Implant Essure under FDA Scanner

If we’d gotten a dime every time a popularly used and widely prescribed drug was recalled for risk of health complications that were unknown earlier, we would be billionaires by now.

At some point, one starts to wonder where the interests of the people promoting these drugs really lie.

The recent one to be pulled up by the FDA is the contraceptive implant called Essure which is marketed by Bayer, one of the world’s largest pharmaceutical corporations.

According to recent reports, the FDA now requires women to sign an agreement citing that they are aware of the potential risks of using Essure before they are prescribed.

What is Essure?

Essure is a contraceptive implant that consists of two metal coils that are intertwined. Each coil is inserted into each fallopian tubes via the vagina.

The controversy arises apparently from the methodology by which it prevents the sperms from fertilizing the eggs. Essure scars the tissue in the fallopian tube by constantly irritating it which affects sperm motility. Surprisingly enough, the contraceptive is touted to be almost 90% effective and it is a permanent implant that will keep you safe from an unwanted pregnancy for life.

However, there have been reports of the implant accidentally puncturing the fallopian tubes. At times, even the uterus.

In worse cases, the tubes have reportedly made their way into other organs such as the pelvis and the abdomen triggering a domino effect of pain, allergic reactions and complications.

The number of cases where Essure has caused complications and required emergency surgical intervention have become so severe that the FDA has finally decided to step in and limit sales.

Fetal deaths?

According to other unconfirmed, but independent reports, Essure has also been associated with fetal deaths.

More than 25,000 reports of adverse effects have been reported since Essure first hit the market in 2002.

Of these, almost 17000 have been reported last year.

Why the sudden increase in the number of complaints, one wonders.

According to Bayer, the sudden barrage of negative press in the time of social media is what has led to a decline in sales as well as an increase in complaints.

Well, for now, Bayer has released a new product label for Essure that highlights the potential risks of using the device.

Meanwhile, thousands of women who have used Essure have sued Bayer for millions of dollars in compensation. None of these cases have concluded yet but if recent reports or incidents are to go by (Johnson & Johnson), then all doesn’t seem hunky dory for Bayer in the days to come.

Symptoms of a complication with Essure

If you have had Essure implanted in your body and are wondering whether you might also be eligible for a compensation from Bayer, then here are some of the common symptoms that are being reported by women.

  • Headache
  • Sudden weight gain
  • Continual fatigue
  • Hair loss
  • Mood swings

Are you experiencing any of these? Then speak to your healthcare provider about the possibility of these being related to Essure.