South American country distributes faulty birth control pills, 170 women become pregnant
SANTIAGO, Chile - According to a recent report from CNN, at least 170 women in the South American country of Chile claim to have become pregnant after taking faulty birth control bills.
The oral contraceptive the women say they took is called Anulette DC, which is manufactured by Silesia, a subsidiary of the German pharmaceutical company, Grünenthal.
CNN reports that the group of 170 who became pregnant after taking the pills are preparing to file a class action lawsuit in the country's civil courts, they're currently being represented by a Chilean sexual and reproductive rights group known as 'Corporación Miles.'
Rojas, one of the women being represented by Corporación Miles, says it was September of 2020 when she realized she was with child. Rojas told CNN she'd only been taking Anulette for five months.
Rojas later learned, after seeing it posted on Facebook, that her birth control bills 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. At that point, Rojas was already six weeks pregnant.
Anulette CD, a 28-day combined oral contraceptive, contains synthetic versions of the hormones estrogen and progesterone, which are produced naturally by the ovaries. The hormones prevent ovulation, meaning no egg is released by the ovaries, and thicken the lining of the cervix to make it harder for sperm to pass through. The pill also causes the lining of the uterus to thin so that if an egg is fertilized, it cannot implant and grow.
Pill regimens usually require 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.
CNN notes that 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.
The news outlet goes on to report that the placebo (a blue pill) had been found where the active pills (a yellow pill) should have been, and vice versa.
In an online notice, published on August 29, the ISP said the makers of Anulette CD, a company called Laboratorios Silesia S.A. (Silesia), had been notified and were withdrawing the defective lot. The ISP then advised health centers to quarantine any packets they had from the affected batches.
After this, 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.
One 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. But when the problems were flagged, Silesia said it had already distributed 137,730 packs to health centers.
The ISP said it would be suspending Silesia's registration until the laboratory was able to improve its quality and production processes. But, CNN notes, "it was too little, too late."
According to the manufacturer's own accounts, a total of 276,890 packets of Anulette CD from the two defective lots had been distributed to family planning centers across Chile.
On September 8, less than a week after Silesia's suspension, the ISP issued another document reversing its earlier decision. In the notice, which was uploaded to its website, the health authority said Anulette CD could once again be distributed, claiming 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 they informed the public health service "to inform users of this situation and take pertinent actions," adding 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, mentioned earlier, said she was only informed by her local clinic about the defective pills after she went in for a prenatal checkup.
So, it was left to Chilean civil society to raise the alarm, and that's exactly what Corporación Miles did by running a social media campaign and using its networks to get the word out.
"It was after [posting on Instagram] when we started receiving emails from people saying that they were already pregnant because they were consuming Anulette," said Corporación Miles' legal coordinator Laura Dragnic.
By April 2021, some 170 women have gotten in touch, but Dragnic expects this number to increase as rural women and those without access to the internet or television have yet to be reached.
"We expect that there are many more women with this problem," she explained, "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."
One week after Dragnic spoke to CNN, Chile health authorities announced that Anulette's manufacturers had been charged a series of fines totalling approximately 66.5m Chilean pesos (approximately USD $92,000).
Miles and their partners are now demanding that the government pay financial reparations to the affected women, and provide access to safe and legal abortions for those who wish to terminate their pregnancy.
Grünenthal is the Santiago-based factory where Anulette CD is manufactured, and its best known for producing tramadol, an opiate pain killer.
Though the company is among "the three biggest pharmaceutical companies in Chile," CNN reports that its long-standing production issues have affected a range of oral contraceptives marketed not just by Silesia S.A. but also Grünenthal's other Chilean subsidiary, Andrómaco.
CNN states that, 'in 2018, Tinelle, a contraceptive pill from Silesia's portfolio, was voluntarily taken off the market after a decision to switch the sequence of the active and placebo tablets (keeping the same numbers of each but placing them in a different order) which -- by the Grunenthal spokesperson, Florian Dieckmann's admission -- "confused [patients] about the new sequence of the pills." Dieckmann said that the pills were put back on the market after Silesia "further clarified the instruction on the aluminium foil on how to follow the right sequence of tablets."'
The news outlet also uncovered information regarding two more recalled oral contraceptives, Minigest 15 and 20, manufactured by Andrómaco at the Grünenthal Chilean plant, which were recalled in October 2020. The recall occurred after the public health authority, the ISP, said they were found during stability testing to contain an insufficient amount of the active ingredient: the hormones.
Grunenthal's spokesperson said that at the time of packaging, the tablets had "the correct amount of active ingredient" in them, and said that the "tablets are exposed to excessive temperatures and humidity over the products entire shelf life under laboratory conditions" and that it is "unlikely that the tablets are exposed to these conditions for a long time in real-world circumstances.
Based on a Freedom of Information request by Corporación Miles, which CNN then followed up on, the production of Anulette CD has had the most problems, according to the ISP's own records.
Between August 6 and November 18, 2020, health clinics throughout Chile reported a variety of issues with the pills including small holes found in the tablets; pills that had orange and black spots; wet and crushed tablets; and packaging that wouldn't release the entire pill effectively, leaving trace amounts of the pill stuck inside.
In total, the ISP received 26 different complaints about 15 different batches of Anulette pills, yet only 2 batches were recalled, CNN reports.
Aside from publishing details of the above recalls on its website, the ISP allegedly did little else to notify women.
Paula Avila Guillen, Executive Director at the New York Women's Equality Center, a not-for-profit that advocates for and monitors reproductive rights in Latin America, told CNN that if the recall was about bad meat, the entire country would have known immediately, and the product immediately taken off the market. "But when it comes to women and reproductive health, they just don't care," she lamented.
Corporación Miles and its partners, writing to the Inter-American Commission on Human Rights and to the United Nations, have labeled the situation as "a clear situation of systemic discrimination against women."
Chile's current abortion laws forbid a woman from terminating a pregnancy with the exception of a pregnancy that is the result of rape, if the fetus is incompatible with life outside the womb, or if a woman's life is at risk.
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