More than 300 fetal deaths and at least five adult deaths have been linked to the nonsurgical, permanent birth control method Essure, according to a private analyst’s review of FDA medical device reports.
Madris Tomes, founder and chief executive officer for Device Events, pored through thousands of complaints made to the FDA’s Adverse Events database as part of an FDA safety review on the contraceptive. The agency is expected to decide later this month whether to recommend additional clinical trials or update the safety label of Essure.
The FDA review was prompted in part by thousands of reports of adverse events posted on the Facebook group Essure Problems. A group of women who call themselves E Sisters also banded together to urge the FDA to pull the device off the market and lift restrictions that protect its manufacturer, Bayer Healthcare, from litigation.
Essure was approved by the FDA in 2002 and remains the only nonsurgical permanent birth control method on the market. It consists of two nickel alloy coils that are inserted into the fallopian tubes. The coils encourage the buildup of scar tissue that acts as a barrier preventing the sperm from reaching the egg.
The implants have been linked to a host of side effects including allergic reactions, infections, chronic pain, and autoimmune conditions. The coils can also migrate and perforate the fallopian tube or uterine wall, or embed into other organs, often requiring hysterectomy or surgical removal.
The five deaths in women were caused by infection and uterine perforation.
Surprisingly, the FDA’s review of its own data only revealed five fetal deaths, a disparity that Tomes says was because the agency searches broad headings of adverse event reports rather than searching the detailed texts within the complaints.
“When adverse events go to the FDA, ‘death,’ ‘injury’ or ‘malfunction’ are the boxes you check,” Tomes explained. “My system searches the (wider) narrative.” For example, Tomes uses keywords such as “fetal death,” “stillbirth,” and “miscarriage.”
Source: Fox News