The manufacturer tallied a total of 276,890 packets of Anulette CD from the two allegedly defective lots that had a January 2022 expiration date that had been distributed to family centers across Chile.
More than 170 women in Chile are pregnant due to faulty birth control pills allegedly distributed by Chile’s government, according to CNN.
The oral contraceptive was Anulette CD, manufactured by Silesia, a subsidiary of the German pharmaceutical company, Grünenthal, according to The New York Times. Most of the women obtained the pills through Chile’s public health system, the Instituto de Salud Pública de Chile (ISP), which 80% of women in the country rely on, VICE World News reported.
The pills are a 28-day oral contraceptive. Like many other oral birth control pills, packets of Anulette CD include 21 active pills, which are yellow, and seven blue placebo pills, which are intended to be taken during the time the user is menstruating, according to a report.
The first batch, 139,160 packs of Anulette pills, according to its manufacturer, was recalled on Aug. 24, 2020, after healthcare workers identified six packets of defective pills, CNN reported.
On Sept. 3, the same error was detected in six packets from a different batch at a clinic in Santiago, according to CNN. By the time the issue was flagged, Silesia said 137,730 packets had already been distributed to health centers. And by the time the ISP said it would suspend Silesia’s registration until quality control and production was improved, it was apparently too late.
The manufacturer tallied a total of 276,890 packets of Anulette CD from the allegedly two defective lots that had a January 2022 expiration date that had been distributed to family centers across Chile, according to CNN.
At least 170 women who say they became pregnant while taking Anulette CD when the allegedly defective pills were circulated are now preparing to file a class-action lawsuit in the country’s civil courts. They are being represented by Corporacion Miles, a Chilean reproductive rights group, ABC affiliate WBRZ News 2 reported.
“Women were trusting the pills they were given by state-run clinics. The fault is not only with the laboratory but also with the government. They are both responsible,” said Anita Peña Saavedra, director of Corporacion Miles.
The case has drawn attention from activists all over the country and has been a call to action for women to have greater reproductive rights in the country, where abortion is illegal except in cases of rape, if the mother’s life is at risk, or the fetus cannot survive outside the womb, a report said.
“We’ve never seen such a systemic failure, that lasted as long as the case in Chile, with such severe consequences,” Paula Ávila-Guillén, the executive director of Women’s Equality Center, which monitors reproductive rights in Latin America, told The New York Times.
The problem, stated the Chilean health ministry and Silesia, was not the pills, but the packaging, the Times reported. The oral contraceptive packets include 21 yellow (active) pills, and seven blue (placebo) pills (taken when the user is menstruating); an “undetermined number of packets included placebo pills in the active slots and vice versa, according to the alert,” the Times reported.
On Sept. 8, 2020, the ISP announced on its website that the Anulette CD could once again be distributed. The health authority claimed that any possible flaws in the packaging could be easily detected. The responsibility to inform the public was put on the healthcare workers who were distributing the oral-contraceptive packets, according to CNN.
The Ministry of Health told CNN that they informed the public health service "to inform users of this situation and take pertinent actions," and said that they provided support and counseling for reproductive health workers to support "women who may have been affected by problems in the quality of contraceptives."
The ISP director told CNN they defend their decision to put the oral contraceptive back on the market.
The makers of Anulette CD said they withdrew the allegedly defective pills as soon as they found out and the Chilean health authority told all the health clinics about the packets. They also said a tweet was sent out from the ISP, but critics said the recall did not reach enough people. For many, they say they learned about the recall when they were already pregnant.
Some say the government offered no further information on how to help those already affected. In addition, Silesia, the laboratory that manufactures Anulette reportedly issued a warning about the batch, yet failed to give an apology or offer help for women experiencing unwanted pregnancies, VICE World News reported.
Laura Dragnic Toha, the legal coordinator at Corporacion Miles, told CNN that the law firm ran their own social media campaign that was distributed on the Chilean networks to get the word out. By October 2020, after their campaign, 40 women got in touch with their firm, and another 70 came forward after a representative from Miles made media appearances, said a report.
“We expect that there are many more women with this problem, especially because the State has not claimed any responsibility and has not made any statements or any serious compromises [to the abortion rules] for the affected women,” Dragnic Toha told the news outlet.
Dragnic Toha, and the legal team are calling on the government to financially compensate those women who were affected and to have access to a legal and safe abortion for those who want to terminate their pregnancy.
According to CNN, six months after the first recall, the health authorities announced that Anulette’s manufacturers had been charged a series of fines totaling $92,000, or 66.5m Chilean pesos.
Silesia told Inside Edition Digital in a statement that in August 2020, Laboratorios Silesia initiated the recall of a batch of the combined oral contraceptive Anulette CD due to irregularities that resulted in empty cavities and misplaced tablets. In early September 2020, the laboratory decided to conduct a voluntary recall of the next batch, B20035A, after identifying a similar irregularity. A total of 12 defective packs were found in both batches. These irregularities, they said, were visible through the transparent blister foil and were detected in 12 blisters out of a total of 276,890 across both batches. This involved a clinical format that was only distributed to the National Supply Center (CENABAST). The contraceptive efficacy of the tablets was never compromised, they said.
Laboratorios Silesia said they recalled both batches after becoming aware of the issue. As a preventative measure, the Institute of Public Health (ISP) announced a temporary suspension from the register of approved products on Sept. 8, 2020, which was lifted on Nov. 24, 2020 because all quality requirements had been met by that point, the said. The type of withdrawal instructed by the authority was carried out according to international standards and at the level of the health service, not at the level of users.
The company told Inside Edition Digital that the Laboratorios Silesia investigated the matter and has shared the results with the Institute of Public Health (ISP). Likewise, preventative and control measures have been implemented to ensure manufacturing quality and make certain that all requirements from the health authority were fulfilled, the company said. Anulette CD remains available to users and providers with no restrictions for manufacturing and distribution, it said.
"As a science-driven company, it is our commitment to provide safe and effective oral contraceptives so that women are in a position to make their own decision and choices about their reproductive health,” said the company statement.
They said that the clinical efficacy of modern contraceptives does not reach 100% due to various factors described in multiple studies and is measured by the Pearl Index. According to studies, the pregnancy rate during the first year of use of a combined oral contraceptive reaches 5.5 to 7 per 100 women per year.
Dragnic Toha of Corporacion Miles told Inside Edition Digital that they already initiated more than 50 mediations against the State.
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