In Chile’s arid Atacama desert, Tabita Daza Rojas is trying to scrape together enough money to finish construction on her home before her baby, due any day, arrives.
Eight hundred kilometers to the south, in La Pintana, a suburb of the capital Santiago, Cynthia González is nursing her two-month-old boy. But she needs to buy milk to supplement her body’s supply and is worried about how she’ll afford it.
Rojas and González come from different backgrounds, have different lives and ambitions. Yet they and at least 170 other women at the time of writing share a common reality: they all claim to have fallen pregnant while taking Anulette CD, an oral contraceptive pill manufactured by Silesia, a subsidiary of the German pharmaceutical company, Grünenthal.
Without the option to legally terminate their pregnancies, if they wanted to, or any real accountability from the government or the drug companies, the women, represented by the Chilean sexual and reproductive rights group Corporación Miles, are preparing to file a class-action lawsuit in the civil courts.
In a region where barriers to women’s reproductive rights are the norm, CNN has identified a government health agency quick to shift the blame to these women, as well as a history of poor production quality and previous issues relating to oral contraceptives in Grünenthal’s Chilean factory its gateway to Latin America.
Tabita Rojas’ story
In March 2020, after discovering an ovarian cyst her physician worried could have been caused by her contraceptive implant, Rojas’s doctor at her local health clinic advised she take the pill instead, prescribing Anulette CD.
Rojas didn’t give the switch much thought; she had taken oral contraceptives before and agreed it made sense for her health.
Plus, after giving up her place on a forensic criminology program at 17 because she’d gotten pregnant, the now 29-year-old was once again excited about her future.
“I had to put all that aside and dedicate myself to my son,” said Rojas, who had a second child two years later, and provides for her family by doing seasonal work at a grape packing plant.
By early 2020, however, things were changing. Her children boys now aged 11 and 9 years old, both with learning difficulties were more independent and were spending more time with their father. As part of government urbanization in her hometown Copiapó, Rojas had been given a small piece of land on which to build a house. She had been saving up money and planned to move out of the home she and her children had been sharing with three other family members.
And, she was in love.
Early on in the relationship, Rojas and her boyfriend had decided not to have children together. “It was going to be impossible to provide for someone else,” she said.
But in September 2020, just five months after Rojas began taking Anulette, she found out she was pregnant again. She would later learn, after seeing it posted on Facebook, that her tablets were from a batch that had been recalled by Chile’s public health authority, the Instituto de Salud Pública de Chile (ISP) the month before.
“I was about to finish the second [box of three prescribed] when I found out about the problem,” she said. By then she was already six weeks pregnant.
I was never happy with this pregnancy
The details may differ but similar scenarios have been playing out across Chile.
A mother of four, González, who had been on Anulette for eight months, got pregnant for the fifth time in May 2020.
She tells CNN that she took her contraceptive “religiously every morning,” before adding: “Because we women set an alarm for those kinds of pills.”
The news devastated her. Her personal life was complicated and her finances extremely limited after she lost the market stall where she sold second-hand clothes.
“I was never happy with this pregnancy,” González said. “If you only knew all the nights I spent crying thinking that I didn’t want to [have the baby]. I had no options.”
Alluding to Chile’s strict abortion laws that forbid a woman from terminating a pregnancy except for three reasons (if the pregnancy is a result of rape, if the fetus is incompatible with life outside the womb, or if a woman’s life is at risk), González spoke about her upset and how she tried to conceal her growing tummy.
“I hid the pregnancy for a long time so that they wouldn’t ask me: ‘Hey, another child, and whose is it because you are no longer with your husband’ and having to explain that we were separated. It was already a complicated situation for me, let alone to go around telling everyone.”
Anulette CD is a 28-day combined oral contraceptive one of the most common forms of birth control.
It contains synthetic versions of the hormones estrogen and progesterone, which are produced naturally by the ovaries. The hormones work to prevent ovulation meaning no egg is released by the ovaries as well as thicken the lining of the cervix to make it harder for sperm to pass through. The pill also makes the lining of the uterus thinner so that if an egg is fertilized it cannot implant and begin to grow.
Pill regimens typically involve taking 21 “active” pills that contain the hormones and seven “non-active” or “placebo” pills, to maintain a daily routine, during which time a person bleeds.
The first batch 139,160 packs of Anulette pills, according to its manufacturer were recalled on August 24, 2020, after healthcare workers at a rural healthcare clinic complained that they had identified 6 packets of defective pills.
In them, based on information from the ISP, the placebo (a blue pill) had been found where the active pills (a yellow pill) should have been, and vice versa.
In its online notice, published on August 29, the ISP said that the makers of Anulette CD, a company called Laboratorios Silesia S.A. (Silesia), had been made aware and were withdrawing the defective lot. The ISP then advised health centers to quarantine any packets they had from the affected batches.
Then, a tweet was sent from the ISP account alerting its followers to the recall. But without a nationwide campaign to more directly inform the public, the recall went largely unnoticed.
A week after the first recall, on September 3, the same error was detected in 6 packets from a different batch at a clinic in Santiago. Here, tablets were also missing, but others were crushed, according to the ISP. By the time the problems were flagged, Silesia said it had already distributed 137,730 packs to health centers.
This time the ISP said it would be suspending Silesia’s registration until the laboratory was able to improve its quality and production processes. But it was too little, too late.
In total, according to the manufacturer’s own accounts, 276,890 packets of Anulette CD from the two defective lots all with a January 2022 expiry date had been distributed to family planning centers across Chile.
Surprisingly, on September 8, less than a week after Silesia’s suspension, the ISP issued another document reversing its earlier decision. In the memo, which was uploaded to its website, the health authority said Anulette CD could once again be distributed. It claimed that the flaws in the packaging could be easily detected, and passed the responsibility of doing so, and of informing users of the service, onto healthcare workers.
The Ministry of Health told CNN in an emailed statement 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.”
But Rojas said she was only informed by her local clinic about the defective pills after she went in for a prenatal checkup. And Rodriguez told CNN no one has contacted her.
ISP director Heriberto Garcia defended the decision to put Anulette back on the market, saying in a video interview with CNN: “Just because it [one pack] belongs to the batch doesn’t mean it was bad.”