Medical Plastics News takes a look at some of the biggest stories that have emerged over the past week.
MPN Weekly News
Raising awareness
Zilico, a diagnostics company based on the Manchester Science Park, is helping raise awareness this month for gynaecological cancers.
The company is supporting The Eve Appeal’s UK campaign to help people become more aware of the early signs and symptoms of gynaecological cancers. Zilico is highlighting stories by clinicians, patients and their partners on social media throughout the month.
Sameer Kothari, CEO of Zilico said: “I admire the work of The Eve Appeal as it helps raise awareness of gynae cancers. Too many women are diagnosed with gynae cancers each year so it’s important that both women and men know what to look out for.”
Going Gaga
A medical device designed to help treat pain associated with fibromyalgia has been approved for EU markets.
The Avacen 100 is a class II medical device that non-invasively infuses heat into the circulatory system to create muscular relaxation while increasing microcirculation throughout the body.
The condition was recently put into the spotlight by Lady Gaga, who revealed she had been living with the disorder. The long-term condition causes pain all over the body, thought to be caused by abnormal levels of chemicals in the brain which change the way the central nervous system processes pain messages, according to the NHS.
Avacen Medical CEO Thomas Muehlbauer said the Avacen 100 is “the only medical device on the market today able to provide non-invasive, rapid whole-body treatment, using a single point of contact. It is the ideal drug-free and safe alternative for relief of muscle and joint pain.”
Five deaths linked to gastric balloon devices
The FDA has announced that five people have died due to issues with weight-loss balloon devices.
The deaths have all occurred since 2016 and are linked to intragastric balloon systems developed by both Apollo Endo-Surgery and ReShape Medical.
The FDA states that all five deaths occurred within a month of balloon placement, with three patients dying as soon as one to three days after being fitted with the device.
The FDA said in a statement: “At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and oesophageal perforation, or intestinal obstruction).”
The FDA is also aware of two more deaths in the same time period which are related to potential complications associated with balloon treatment.
Bayer end sale of sterilisation device
Bayer has announced it will stop selling it Essure sterilisation device in all non-US countries.
Recently there has been controversy surrounding the device which is intended to prevent pregnancy by being inserted into the fallopian tubes. Earlier this year however some women were reported to have been experiencing strong levels of pain and discomfort due to the devices.
Bayer states that the decision to end sales of the product in the selected regions is not due to a ‘safety or product quality problem’ and is instead being made for commercial reasons.
More so, the company claims that the device’s ‘positive benefit-risk profile remains unchanged’ and that its ‘safety and effectiveness remain supported by more than ten years of scientific research and real-life clinical experience’.
Bayer argues that a number of factors such as the temporary suspension of the device’s CE marking and a recall of the device in France created an unfavourable environment and led to a ‘continuous decline in demand’.
