Last Friday, July 20, Bayer stated that they will no longer distribute or sell the Essure permanent birth control device in the United States after December 31, 2018. According to FDA Commissioner Dr. Scott Gottlieb, “The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.”
From 2002 through 2017, the patient problems most frequently reported to the FDA were pain/abdominal pain, heavier menses/menstrual irregularities, headache, fatigue and weight fluctuations. Consumer Safety indicates that around 16,000 lawsuits have been filed against Essure, causing the FDA to issue tighter regulations on the Essure birth control devices in April. Bayer is saying that this decision is purely business and that the support for Essure birth control devices is very strong and safe.
“Essure is the only non-surgical permanent form of birth control for women marketed in the US, which is inserted into the fallopian tubes, where scar tissue forms and builds a barrier to block sperm from reaching and fertilizing a woman’s eggs.”
FDA Timeline on Essure
The FDA notified Bayer that it discovered the company had been making Essure implants in an unlicensed factory since at least 2005, and that the company had failed to document their procedures appropriately.
Bayer was cited by the FDA for using unapproved materials in the Essure device, in violation of the premarket approval, which required the company to seek additional approval for any design changes.
The FDA ordered Bayer to conduct a new clinical trial to determine whether there are any heightened risks of Essure for certain women, based on adverse event reports filed to the agency.
The FDA required a black box warning be added to Essure device labels indicating the risks of perforation, abdominal pain, and allergy, among other potential complications.
The FDA restricted sales of Essure to doctors and medical centers that promised to conduct a conversation and go through a checklist with the patient before prescribing Essure.
Best Birth Control Alternatives
Essure was originally introduced as an alternative to tubal ligation. However, considering the increased risks associated with the device, more women are giving the surgical option a second look.
“In a tubal ligation procedure, a doctor puts a patient under general anesthesia and makes small cuts in her abdomen to allow the insertion of a telescope-like instrument called a laparoscope. The doctor then uses the laparoscope to seal the fallopian tubes shut, blocking the passage of sperm and preventing the egg from getting to the uterus.”
Pros: Having your “tubes tied,” as the phrase goes, is permanent and 99.5 percent effective at protecting against pregnancy. Additionally, tubal ligation eliminates the possibility of human error—such as forgetting to take a birth control pill—and doesn’t affect a woman’s hormones.
Cons: Tubal ligation is permanent and difficult—and costly—to reverse, should you change your mind. Also, although tubal ligation is considered a safe and routine procedure, it’s not completely without risk. Accidental injuries to the bladder, bowel, or arteries can occasionally occur. There is also a slight risk of pregnancy. Finally, unlike condoms, tubal ligation does not offer protection against sexually transmitted diseases and infections.
Vasectomy, the male form of sterilization, is a simple and safe procedure that can usually be performed right in a doctor’s office. It requires the cutting and sealing of the tubes that carry sperm, known as the vas deferens. The procedure does not affect the man’s ability to ejaculate or achieve orgasm and is considered safer and less painful than tubal ligation.
Pros: Vasectomy is an outpatient procedure that can be performed in a doctor’s office in 30 minutes or less. Men can usually go back to work in 24 hours and resume other activities within a week. Vasectomies have a 99 percent success rate and, if desired, can be reversed with a success rate between 70 and 90 percent. Additionally, the procedure does not affect a man’s testosterone level, sexual desire, or production of semen.
Cons: Vasectomy reversals can be costly and, in some cases, may not be successful. Some men also report temporary discomfort for a few days after the procedure, such as mild swelling and bruising.
Temporary/Semi-Permanent Birth Control Options
If you’re not sure about tubal ligation or vasectomy, there are also temporary and semi-permanent birth control options to consider, such as birth control pills, IUDs and birth control implants.
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