Reproductive Health Care and the Medical Device Industry


Essure has been marketed by the medical device industry as a form of permanent contraception, a method intended to bring about sterilization in the female reproductive system. Essure was appealing because it did not require surgery; health care providers would insert coils through the vagina and the cervix, into the fallopian tubes. The device would generate scar tissue and cause a closure within the tubes, blocking the transmission of sperm.

It was approved by the FDA (Food and Drug Administration), despite unanswered questions about the device. For many years, reports of adverse events associated with Essure have included development of autoimmune disorders, chronic pain, perforation of the uterus or the fallopian tubes, migration of the device from the fallopian tubes into the uterus, heavy irregular bleeding, headaches, pelvic pain, pain during sex, and unintended and ectopic (dangerous) pregnancies.

The documentary filmmakers who produced The Invisible War (covering sexual violence in the military) and The Hunting Ground (covering sexual violence on campus) have released a new film called The Bleeding Edge. In it, they expose the shortcomings of the medical device industry. Some of the medical devices that they investigate were designed with reproductive health care in mind: Essure (a sterilization method), and vaginal mesh (material that has been used to treat pelvic organ prolapse and urinary incontinence).

They feature testimony from patients who had experienced grave and life-altering complications following the use of these medical devices. Essure and vaginal mesh were profitable to the medical device industry, and found to be unsafe in many instances; vaginal mesh caused complications including pain, infection, bleeding, and organ perforation. Facing thousands of adverse event reports, lawsuits, and public controversy, the manufacturer of Essure will withdraw it from the U.S. market at the end of 2018.

Access to safe reproductive health care is a right, and many survivors of sexual violence may need different reproductive health care services. There are many reproductive health care and contraceptive options that are safe and effective, just as there are many life-saving medical devices that providers and patients use every day— like stethoscopes, inhalers, and EpiPens.

There is no shortage of medical providers and research scientists who want to serve patients as well as possible, but poor government regulation and powerful business entities are a part of the health care landscape. Some awareness of its complexity is essential; patients should be informed consumers in a profit-driven industry as health care coverage and reproductive health care access are challenged in the U.S.

To learn about available and effective contraceptive methods, Planned Parenthood offers a helpful guide, and it is a very good place to start.

This post was submitted to End Rape On Campus anonymously.

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