Bayer's Essure was a metal and polyester coiled device that was put into women's fallopian tubes to block the pathway between sperm and egg. After it was approved for sale in the United States, women began to complain that it caused allergic reactions and chronic pelvic pain and led to hysterectomy. In some cases it was lethal. Although eventually the FDA required a black box warning on the packaging, a Freedom of Information inquiry revealed that the company had 32,000 complaints about the device that had not been sent on to the FDA. Eventually, more than 39,000 women sued Bayer or hired lawyers over their use of Essure. In 2020, with no admission of wrongdoing, the company settled claims against it for $1.6 billion.
In other instances, the authors pointed out, adverse event reports were made to the FDA but not shared with the public. Silicone breast implants were not allowed from 1992 to 2006, and when newer materials became available for implants, the public and doctors assumed they were not risky–even though there were no long-term studies of the effects of those materials when implanted in the breasts. However, as concerns grew, "safety advocates began meeting with the FDA in 2015. In 2018, the agency revealed that the adverse event reports existed but were not made public, despite the mandatory reporting requirement. During a public meeting in 2019, the FDA acknowledged that the agency had received over 300,000 breast implant adverse event reports–20 times more than they had previously admitted publicly. After this meeting, then-FDA Commissioner Scott Gottlieb promised release of all AE reports collected through 'alternative summary reporting,' most of which were released in June 2019."
Sex Cells: the Fight to Overcome Bias and Discrimination in Women's Healthcare, by Phyllis E. Greenberger, MSW