On Friday 8th March the Food and Drug Administration, (FDA) was required to issue a letter to health care providers saying that it was going to review surgical staplers. The review was prompted a day after Kaiser Health News released an article on its investigation on surgical staplers.
Kaiser Health discovered that since 2016 reports of surgical staplers malfunctioning during surgery and causing horrific injuries to patients including death were buried in hidden from surgeons and the public in ‘summary reports’.
Surgical Staplers cut and seal blood vessels and tissues during surgery. When staplers fail to fire, patients have bled profusely and have suffered dire injuries including death.
On Saturday we attempted access the TGA’s DEAN database to determine how many adverse events were listed for surgical staplers. However, we were not surprised to find the TGA’s website was again closed for scheduled maintenance.
It appears that closing the TGA’s website for scheduled maintenance is a new PR strategy.
On the weekend Netflix released its documentary exposing the unregulated, multi-billion medical device industry The Bleeding Edge, the TGA closed its website for scheduled maintenance.
On Monday night we were able to access the TGA’s DEAN database. We found 133 adverse event reports related to surgical staplers. These reports included staplers ‘jamming during use and unable to reload’, ‘Patients bleeding as device did not release’, ‘device not being able to be removed from tissue’.
The majority of surgical staplers are manufactured by Ethicon who is owned by Johnson and Johnson and Covidien who is owned by Medtronic. These companies are members of AdvaMed and Scott Whitaker often speaks for both these industry giants. If his name is familiar it should be. Scott Whitaker is famous for boasting to medical device manufacturers on Netflix’s, The Bleeding Edge ‘we have more power in this room than most governments.’
FDA spokeswomen Deborah Kortz confirmed in an email to Kaiser health that ‘Any device manufacturer can request an exemption from its reporting requirements.’ We know from their reporting that these exemptions have been granted to pelvic mesh devices.
Since 2016 over 1.1 million adverse events have been included in ‘summary reports’.
On Saturday Mesh Awareness Australia posted evidence that highlighted the Therapeutic Goods Administration(TGA) in 2009, received an email from a surgeon reporting over ‘100 cases’ of ‘mesh complications’ that included ‘pain and dysfunction long term’. However, when the TGA provided evidence at the public hearings for the Senate Inquiry into Transvaginal Mesh, it reported having only received 12 adverse events related to pelvic mesh on December 2015.
On Thursday March 7th, Pain Australia’s CEO, Carol Bennett published an article titled Why Australia needs a medical device identification database’ on LinkedIn.
Carol Bennett highlighted ‘the inability of regulators to trace devices represents a systematic failure of our health and safety regulatory regime.’ She also called for mandatory reporting obligations to be overhauled, a patient database to be created and maintained and for consumers to be well-informed of developments relating to the devices already implanted as well as any devices they may be considering.
In her article she also highlighted the recent published research that linked breast implants to rare forms of blood cancer.
On Monday 4th March 2019, Health Canada issued a press release informing women with textured breast implants of anaplastic large cell lymphoma (BIA-ALCL) being associated with their implants and the symptoms to look for. It also set up a telephone line for patients who may be impacted to receive support.
Health Canada Media Release
‘If you are a patient who has had breast implant surgery at the MUHC and you notice unusual changes in your breasts, including pain, sudden swelling or a mass, please call 514-934-1934, ext. 35953, and leave us your name, phone number, health insurance card number and hospital card number. A nurse will contact you within 48 to 72 hours for a follow-up.”
Unsurprisingly Australia’s regulators and our Federal and State Health Department’s have been silent on textured implants and their link to ALCL. Once again patients impacted are left in the darkness and advocacy groups are left to try and reach them.
If you are concerned about your or someone you know and would like further information on Breast Implants, you can access the following support group.
https://www.facebook.com/Breast.Implant.Illness.Awareness.Aus.NZ/
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References
FDA Letter to Health Care Providers
Pain Australia
https://www.linkedin.com/pulse/why-australia-needs-medical-device-identification-database-bennett/
Breast Implants linked to rare form of blood cancer
Health Canada Press Release
https://muhc.ca/newsroom/news/message-patients-having-had-breast-implant-surgery-muhc