Conceptus

About Conceptus

Conceptus, Inc. was a medical products company founded in 1992 and headquartered in Mountain View, California. The company initially focused on developing micro-catheter and guidewire systems to help physicians access the fallopian tubes for diagnosing and treating infertility. In 1998, the company shifted its focus to develop Essure, a non-incisional permanent birth control device.

The company's flagship product, Essure, received FDA approval in 2002. The device consists of small, flexible metal coils made of polyester fibers, nickel-titanium, and stainless steel. It was designed to be inserted by a physician into the fallopian tubes through the cervix, a procedure that could often be completed in an office setting in under 10 minutes without general anesthesia. Over three months, scar tissue would form around the inserts, creating a natural barrier that blocked sperm from reaching an egg, thus providing permanent contraception. The business model centered on the manufacturing and commercial sale of this device-based solution to healthcare providers. In 2012, Conceptus generated net sales of $141 million.

In a significant milestone, Bayer AG acquired Conceptus, Inc. on June 5, 2013, for approximately $1.1 billion. The acquisition was intended to broaden Bayer's portfolio of contraceptive options. At the time of the acquisition, D. Keith Grossman was the President and CEO of Conceptus.

Following the acquisition, the Essure device faced growing scrutiny. Thousands of women reported serious adverse effects, including device migration, perforation of the uterus or fallopian tubes, chronic pain, and autoimmune reactions. This led to a significant number of lawsuits filed against Bayer. The FDA mandated a "black box" warning for the product's packaging in 2016 and restricted its sale in 2018 to ensure patients were fully informed of the risks. Citing a decline in sales, Bayer stopped selling and distributing Essure in the United States on December 31, 2018, and the product was subsequently removed from all markets. In 2020, Bayer announced it would pay $1.6 billion to settle a majority of the nearly 39,000 lawsuits related to the device.