Unequal Harm: Disproportionate Damage to Women from Drugs and Devices

Michelle Garcia of Miami never thought a simple doctor’s office procedure for birth control would result in the removal of both of her fallopian tubes.  Yet last year Michelle underwent surgery to remove Essure, a medical device marketed as a “surgery-free permanent” birth control procedure. It was supposed to be Michelle’s easy solution for birth control for life; instead, it was her worst nightmare, requiring surgery to remove the coils and both damaged fallopian tubes.

Women suffer disproportionately from faulty drugs and medical devices, and Michelle is just one example.  As part of National Women’s Health Week, the American Association for Justice (AAJ) has released “Unequal Harm: The Disproportionate Damage to Women from Dangerous Drugs and Medical Devices,” an analysis detailing a history of a few of the many products that have harmed women over the years.

Because of a Supreme Court ruling (Riegel v. Medtronic), Michelle will never be able to recover any medical expenses for her surgery from the manufacturer of Essure, even though the product was defective and became a hazard to her health.

For decades women have suffered enormously from unsafe medical products, according to the report.  Essure could turn out to be another example of a medical manufacturer putting profits ahead of women’s health.  Unfortunately, because the manufacturer is shielded from litigation, we will never learn the truth about what the company knows about the safety and effectiveness of their product.

The makers of Essure are shielded from litigation because the Supreme Court ruled in Riegel v. Medtronic (2008) that medical devices that have gone through the FDA’s premarket approval process (PMA) cannot be held responsible for injuries, even when the device is defective or has been recalled.

Lawsuits serve as a valuable tool to uncover undisclosed or unknown risks and provide an incentive for manufacturers to promptly disclose safety risks.  Unfortunately, Essure’s maker has a ‘get-out-of-jail-free’ pass from the Supreme Court’s Riegel decision.

Essure is a coil inserted in each fallopian tube that is supposed to create a “natural barrier,” or scar tissue in the tube to prevent pregnancy by blocking the tube. In Michelle’s case, one coil broke and migrated to her abdomen, where it could have pierced a vital organ.  Other women have reported getting pregnant, coils piercing organs, coils migrating to other parts of the body, and having complete hysterectomies because of complications from Essure birth control.