Internet petition wants Congress to oust CDRH head Shuren

A group of upset citizens are petitioning for the removal of FDA Center for Devices and Radiological Health head Dr. Jeffrey Shuren, stating dissatisfaction with the control of devices such as Bayer‘s (ETR:BAYN) Essure and power morcellators.

The movement, which started as an email campaign last October in which 100s of angry individuals sent templated letters to Shuren asking him to revoke the PMA for Bayer’s Essure has now manifested into a petition to congress to fire him for “putting industry concerns before patient safety,” according to MD+DI.

The movement is being led by LASIK activist and former CDRH advisory committee consumer representative Paula Cofer.

“Under the current leadership of Jeffrey Shuren, M.D., the FDA’s Center for Devices and Radiological Health (CDRH) — the arm of the agency that oversees medical devices — has become mission-corrupted, placing industry interests over public health. Failures of the CDRH have harmed countless people and led to many preventable deaths. CDRH is “captured” by industry. Division managers at the CDRH have close working relationships with representatives of medical device manufacturers,” Cofer wrote in an online petition to remove Shuren.

The petitioners state that patient advocacy groups and whistle-blowers who reach out to the CDRH to raise a red flag on medical device issues are shut out and ignored, and that MedWatch reports of device-related injuries “fall into a black hole at the agency.”

In March, it was reported that more than 30 women are suing Bayer over injuries allegedly related to its Essure permanent birth control device, claiming the device led to severe health problems including abdominal cramping, migraines and abnormal menstrual bleeding, according to a law firm’s press release.

The lawsuit was filed March 17 in the Circuit Court of St. Louis, according to the law firms representing the women in the case, who claim they have suffered serious and permanent injuries as a result of using the Essure device.

Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said last year that in the 13 years since Essure’s approval, it had received 5,093 complaints, including for pain or menstrual irregularities after using the device, and complaints of the device breaking. In addition to 5 fetal deaths, there were 4 reports of adult deaths for reasons such as infection and uterine perforation, the FDA said.

In February, the FDA said it would put a pair of measures in place for Essure, mandating a new clinical study and new guidance on using the device.

Last September, the Government Accountability Office said it will investigate potential safety and regulatory issues with laproscopic power morcellators, according to The Wall Street Journal.

The devices use small, rotating blades to break up large tissue masses into fragments, and are commonly used to remove uterine fibroids in women. However, if the device is used on a patient with an undetected cancerous growth, it can enable the cancer to spread, according to the FDA.

The tools have been under the scrutiny of the FDA for over a year – last November, the agency released a security communication warning that women undergoing hysterectomies or myomectomies using power morcellators faced 1 in 350 odds of having an undetected cancer that could significantly worsen through the treatment.

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