Four South African women who used Pfizer’s Depo-Provera for decades blame the injectable contraceptive for causing them to develop brain tumours, but the company has said it would defend any lawsuits, maintaining that Depo-Provera has been approved in more than 60 countries for three decades.
The South African Health Products Regulatory Authority (SAHPRA) has now recommended that the information on products containing medroxyprogesterone acetate (MPA) be updated to include safety warnings about the potential risk of meningioma.
Registered in South Africa as Depo-Provera, Provera, Petogen, Medroxyprogesterone Mylan, Sayana, Omrastoz, Trivina and Triclogyn, MPA is a synthetic oral and injectable form of progesterone, used for contraception and the management of endometriosis-associated pain.
SAHPRA said regulatory action had already been taken in Europe – over products containing MPA – warning of the potential risk of developing the usually non-cancerous tumour.
It is the only brain tumour more common among women than men and tends to occur in middle-aged and older adults, reports New24.
“The regulatory action, which entailed updating product labelling, was based on studies conducted in France and the US, which observed an increased risk of cerebral meningioma with prolonged use of MPA,” said SAHPRA spokesperson Madimetja Mashishi.
However, according to Pfizer, it conducts “rigorous and continuous monitoring of all our medicines”, including assessments of reported adverse events, in collaboration with global health authorities.
“Depo-Provera has been approved in more than 60 countries over the past 30 years and has been a safe and effective treatment option for millions of patients during that time,” a spokesperson told News24. “We will vigorously defend any lawsuits.”
Cape Town’s Shene Gurling (39) had been taking the injection for 22 years, is one of the women diagnosed with the generally benign tumour which originates in the membranes that protect the brain, and which allegedly developed after prolonged use of Depo- Provera.
Gurling had been on the injection since she was 17. At the end of 2023, she started having memory loss, and when the vision in her left eye became impaired, she sought medical advice.
An MRI confirmed a brain tumour, which was affecting her optic nerve.
She had surgery, but because of the meningioma’s proximity to her carotid artery, the entire growth could not be removed. The specialist tour consultant was dismissed by her employer for incapacity.
She also now suffers from seizures, for which she is reliant on epilepsy medication.
Then someone sent her a link to a TikTok post by a Polokwane GP, where he warned women of the meningioma link, as well as the lawsuits being filed against Pfizer, including in the US and Australia.
“I read up on studies … and found they correlate with what happened to me. I was stunned – millions of women in SA use this form of contraception without knowing about this.
“How do you make an informed decision when you are not even aware of the potential dangers?”
Eye problems
When Gauteng’s Lynn van Rensburg (54) started using Depo-Provera 30 years ago, her only concerns were the associated weight gain and the minuscule possibility of still falling pregnant.
“The last thing I expected was to develop a life-threatening tumour,” she said.
At the end of 2023, she noticed increased tearing of her eye. She developed a stye and went to see her doctor. “He said something was wrong – my eye was protruding.” A month later, a neurologist discovered the tumour behind her eye. She went into theatre for a nine-hour procedure, and surgeons managed to remove 80% of the meningioma – it was entwined in her eye socket bone and skull, on the side of her brain.
“They had to grind down the bone to get to the tumour. My skull was (reconstructed with) mesh,” she said.
In addition to a massive physical scar, the following months were characterised by severe depression and dealing with the emotional trauma of her ordeal.
She is scheduled to undergo another MRI next month as her eye has started tearing and protruding again.
Van Rensburg said she never considered that her contraceptive could have been the cause of her tumour until she saw an article on a US website about the study, linking Depo-Provera to meningioma.
“I felt sick after reading it. I was on that injection for three decades.
“What made it worse for me is that so few women know about this. Across the country, people are getting the injection at government clinics, just like I used to. But do they know about the danger?”
‘Rare event’
SAHPRA’s Mashishi said the available evidence “suggests an increased risk of meningioma … is possible, but likely to be rare”.
“Globally, 32 cases have been reported in 20 years, suggesting that the absolute risk of meningioma is small.”
He added that the benefit-risk profile of registered MPA-containing medicines “remains favourable”, and it considers them safe to use for approved indications.
Healthcare professionals are, however, urged to advise patients about the side effects of MPA as per its product information.
“SAHPRA recommends that patients treated with MPA should be monitored for signs and symptoms of meningioma. If this is diagnosed in any patient treated with MPA for a non-oncological indication, use … must be stopped, as a precautionary measure,” Mashishi said.
“If a meningioma is diagnosed in any patient treated with MPA for an oncological indication, further use should be considered on a case-by-case basis, considering individual benefits and risks.”
Paralysis
Vereeniging’s Belinda Potgieter (45) who has had to re-learn how to walk, was left partially paralysed after the removal of her meningioma.
She had used Depo-Provera for 22 years, and her symptoms began with debilitating headaches. “I didn’t expect seven tumours on my brain to be the cause.”
She underwent surgery in 2024 to remove one, which, if left untreated, would have left her paralysed.
Afterwards, she had to learn how to use her hands and walk again after the right side of her body was affected.
“I am struggling. I pop pain medication like Smarties. I can’t work because I have to be cleared by a doctor to say I am able to do my job at the accounting firm where I work. If I had known the side effects … I would never, never have taken it.”
Massive growth
Gqeberha’s Tanya Dippenaar (47) is another case: she now has nerve damage to her face, damaged brain cells, and the inability to experience taste on the left side of her mouth.
She has been living with a growth stretching from her frontal sinuses to the back of her ear and into her temporal lobe for years as it is too big for doctors to even consider operating.
She had been on Depo-Provera from 2003 until 2014.
In 2017, she developed an ear infection, and for nearly five years, saw various ENT doctors and specialists.
“I told them that apart from the pain and discomfort, I felt pressure in my left eye. I knew something wasn’t right. But no one could figure out what it was.”
She underwent six procedures, including one for a titanium grommet. Nothing worked.
In 2021, an ENT specialist sent her for a CT scan, which revealed an extensive meningioma. She was told it cannot be removed as the risk of surgery outweighs any benefits, one being the possibility of facial paralysis.
She underwent 30 radiation sessions in efforts to reduce its size. The treatment caused memory loss, fatigue and severe head pain.
She believes Pfizer must take responsibility.
“They can’t say they didn’t know…I find that impossible to believe.”
The women say they do not have the money to sue. They are adamant, however, that they want to spread awareness so others don't have to go through what they have endured.
See more from MedicalBrief archives:
High doses of hormone drug linked to meningioma risk – Meta-analysis
Prolonged use of some hormone drugs tied to tumour risk
Despite HIV risk, withdrawing Depo-Provera could increase maternal mortality
Depo Provera associated with doubled bone loss in women starting ARVs