There are no plans to withdraw the 100mg hormone replacement therapy (HRT) implant, despite reports to the contrary on ITV's Tonight programme on June 15.
The programme said that there were safety issues surrounding use of high strength oestrogen implants. It suggested that their use could result in oestrogen overdose. Patients described side effects such as depression, blackouts, mood swings, lethargy, nausea and blood clots.
The UK manufacturer of oestradiol implants, Organon, says that it will not be withdrawing its 100mg implant - the highest dose product - from the market. Dr Henk Jan Out (medical director, Organon) told The Journal on June 19 that there was "no safety issue whatsoever," provided that the implants "are used according to the instructions". They should not be implanted more frequently than every four to six months and only following measurement of oestrogen levels, he said. If reimplanted too soon, high levels of oestrogen could result. Dr Out said that the implant had been marketed for over 50 years. Extensive experience of its use led Organon to conclude that there was no reason to worry about its safety.
Dr Out said that there was a general issue about the safety of HRT and that the demand for higher dose products world-wide was falling. It was possible that falling demand for the high strength implant could lead to its withdrawal from the market but he emphasised that this would not be because of any safety issue. However, the product would not be withdrawn "for the time being."
The Medicines Control Agency said on June 16 that, for all HRT products, including oestrogen implants, the balance of risks and benefits was considered favourable when used according to the terms of the product licence. "The balance of benefits and risks for HRT is complex and for the individual woman and her physician to judge," it said.