Tea at Trianon: Essure

John Wilson Croker on Marie-Antoinette

"We have followed the history of Marie Antoinette with the greatest diligence and scrupulosity. We have lived in those times. We have talked with some of her friends and some of her enemies; we have read, certainly not all, but hundreds of the libels written against her; and we have, in short, examined her life with– if we may be allowed to say so of ourselves– something of the accuracy of contemporaries, the diligence of inquirers, and the impartiality of historians, all combined; and we feel it our duty to declare, in as a solemn a manner as literature admits of, our well-matured opinion that every reproach against the morals of the queen was a gross calumny– that she was, as we have said, one of the purest of human beings."

~from History of the Guillotine by John Wilson Croker, 1844

Edmund Burke on Marie-Antoinette

"It is now sixteen or seventeen years since I saw the queen of France, then dauphiness, at Versailles; and surely there never lighted on this orb, which she hardly seemed to touch, a more delightful vision. I saw her just above the horizon, decorating and cheering the elevated sphere she had just begun to move in, glittering like a morning star full of life and splendor and joy. Oh, what a revolution....Little did I dream that I should have lived to see such disasters fall upon her, in a nation of gallant men, in a nation of men of honor and of cavaliers! I thought ten thousand swords must have leaped from their scabbards, to avenge even a look which threatened her with insult. But the age of chivalry is gone; that of sophisters, economists, and calculators has succeeded...."

~Edmund Burke, October 1790

Wednesday, August 2, 2017

Essure

Yet another nightmare for women, compliments of the pharmaceutical industry. From The Washington Post:

Nobody can say exactly how many women have had Essure implanted since the device went on the market in 2002. Bayer, which is headquartered in Germany, says that more than 750,000 devices have been sold worldwide and that sales “continue to grow.” (According to data from Essure clinical trials, device insertion fails anywhere from 4 to 12 percent of the time, making actual usage unclear.) In a telephone interview, Patricia Carney, director of U.S. medical affairs for Bayer Women’s Healthcare, pointed to the total sales number as evidence that “hundreds of thousands of women who’ve received Essure … successfully achieved permanent contraception without having to go through an invasive surgical procedure.”

In recent years, the Food and Drug Administration has received more than 16,000 adverse-event reports about Essure. These are official reports about symptoms, hospitalizations or diagnoses that patients, doctors, hospitals or a device manufacturer believe are associated with a device. They can prompt the agency to order a change in labeling, the addition of warnings or, in rare cases, the removal of a device from the market. Among the reports are nearly 9,000 surgical removals of Essure, mostly by hysterectomy. “That’s a lot of surgeries for a device that’s considered minimally invasive,” says Madris Tomes, a former FDA analyst. Although she and other experts in FDA law and regulation emphasize that there is no magic number of reports that will trigger an investigation, complaints can serve as an important signal to the FDA that it should take another look at a drug or device. (The FDA declined an interview for this article but responded to questions in writing.) (Read more.)