The 15,000-square foot (1,400m) facility in Barreal de Heredia will initially add about 75 employees to Bayer’s 350-member workforce in Costa Rica, where the company has its Central American and Caribbean headquarters, according to the Costa Rican Investment Promotion Agency, CINDE. Bayer spent $12 million on the plant, according to the agency.
“We are proud that such a prominent international company like Bayer has decided to invest in our country to expand its operations in the manufacturing of medical devices which demonstrates its confidence in the Costa Rican human talent and our country,” Costa Rica President Luis Guillermo Solis said in prepared remarks.
Essure, the only permanent birth control device approved for the U.S. market, is a small metal coil placed in the fallopian tubes via catheter. The FDA approved the device in November 2002 under an expedited pre-market approval process; Bayer acquired the device in the $1.1 billion buyout of Conceptus in 2013.
Patients and a prominent activist struck up a hue and cry almost immediately after the Conceptus buyout, agitating for the device to be taken off the market and for Bayer to launch a complete investigation into patient injury claims. But in October 2013 the FDA said that real-world results don’t support reports of extreme fatigue, depression, weight-gain and other issues associated with the implant.
In February, a citizens petition lodged with the FDA asked wants the safety watchdog to take Essure permanent female sterilization device off the market, alleging that the clinical data the FDA used to approve the device was fudged and concealed adverse events associated with Essure. Bayer refutes the petition’s allegations, and in May cited results from a 5-year follow-up of the initial 364-patient cohort from its Phase III trial showing showed no pregnancies after 5 years and that the Essure inserts were “generally well tolerated.”
In June, the FDA scheduled a Sept. 24 advisory panel hearing on Essure, saying it’s received 5,093 complaints in the 13 years since Essure’s approval. There have also been 5 fetal deaths in women who became pregnant after using Essure and 4 adult deaths for reasons including infection and uterine perforation, according to the FDA. The device has been used by about 750,000 women, according to Bayer’s website.
Last month the FDA approved transvaginal ultrasound as an alternate test to confirm proper placement of the Essure device.