DO WE LIVE IN A WORLD WHERE PROFITS MATTER MORE THAN OUR HEALTH?
PERTH: This is the question you will walk away with after watching Netflix’s recent, disturbingly powerful, investigative documentary The Bleeding Edge, directed by Academy Award nominated director Kirby Dick screened by the Health Consumers’ Council for Patient Solidarity week at Luna cinemas in Perth.
The film is a shocking expose on the $400 billion medical device industry, covering the lax regulations for manufacturer’s to introduce new devices to consumer’s without sufficient clinical testing or trials.
“There needs to be an understanding of how devices end up on our Therapeutic Goods Administration (TGA) list,” Pip Brennan, Executive Director of the Health Consumers’ Council told the News Tribe. “Essentially, many devices are approved with very little evidence, and there is a reliance on ‘post-market surveillance.’ The difficulty is that this post market surveillance is not compulsory, nor is it coordinated. Neither the device companies nor the surgeons are reporting all the complications, and there simply is no accountability mechanism in place for these doctor’s or companies.”
The film also exposes the inefficiency of the Food and Drug Administration to protect the consumer or keep patients safe even pointing to evidence that suggests some FDA executives are linked to the medical companies through shares and profit-driven incentives. Trump-appointed FDA commissioner Scott Gottlieb was confirmed despite having huge conflicts of interest, given that he had worked at no fewer than 20 healthcare companies previously.
Despite medical giant’s like Johnson & Johnson and Bayer aware of the potential dangers of their devices, they continue to cover-up or deny the facts, continuing to market these devices as ‘safe and innovative’ raking in million’s of dollars each year in profits through the sale of these products. The filmmakers interview doctors and patients whose lives have been irreversibly damaged by the devices which range from birth control coils, the vaginal mesh, hip implants, breast implants and robotic surgeries.
One such person profiled in the film is Dr. Stephen Tower, an orthopedic surgeon who began to experience extreme neurological reactions from high toxicity caused by his hip implant made of cobalt, a metal used in rechargeable batteries.
More than 16,000 lawsuits have been filed against Bayer over the permanent birth control coil which is implanted into the fallopian tubes, with women citing complications like migraines, hair loss, organ perforation and even unintended or dangerous pregnancies. Many of these women have banded together online in Facebook groups, and the documentary follows several of the thousands of women affected. Some women said the coils slipped into their uterus, causing severe bleeding and the need for surgeries, including hysterectomies for women as young as 29.
When asked what consumer’s can do for their own safety, Pip Brennan stated, “On a personal level, it is very important for people to inform themselves as much as possible before they receive any kind of surgery. No-one else will wear the consequences, so patient’s must be absolutely confident they are making the right choice for themselves. It is also very important to ask surgeon’s how many procedures they have done and what the outcomes have been. If they are unable or unwilling to answer this question, you may want to find a different surgeon. Make sure to also link in with peer support groups – Facebook has a wealth of private groups where people with the same conditions or concerns can share information about their experiences.”
“You may also want to signup to Mesh Awareness Australia’s Petition: A Royal Commission into Australia’s Regulation of Medical Devices. Make sure your friends, families and colleagues know about The Bleeding Edge. Our medical device registration system is not working globally, and it’s not working in Australia. We need people’s voices to help ensure that we reform how we approve and remove medical devices to keep Australians safe and healthy,” Pip concluded.