Have you got Silimed Silicone Implants?
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recommended that no Silimed Silicone Implants be used following reports of contamination.
What are Silimed Silicone Implants?
Silimed is the 3rd largest implant manufacturer in the world, according to the company’s website.
It exports its devices to more than 75 countries worldwide.
Eurosurgical, a company which distributes Silimed’s products in Britain, said it had supplied around 13,000 implants in the UK over the past 5 years.
Silimed’s products include breast, penile and testicular implants. The silicone implants have been used in thousands of operations, including calf implants and gastric band sugery. The Company stated that the contamination was detected during an audit of the company’s manufacturing practices.
What is wrong with Silimed Silicone Implants?
The MHRA and other European regulators are testing the Silimed products. The German notified body found contamination on some implants during an inspection at the company’s manufacturing plant in Brazil. The contamination is from particles and fibres which should not have been there.
“Silicone implants for plastic surgery, urological implants and other surgical devices are among the suspended devices”, the MHRA has stated.
Is there a Recall of Silimed Silicone Implants?
Silimed is in the process of reviewing its products and preparing a technical note. They want to show that its products are in compliance with national and international standards.
The company has stated that there is no need for a recall at the moment. The majority of contaminated silicone is in breast implants.
The MHRA do not know if contaminated products would have reached patients or how many Silimed products are affected. The MHRA statement said that “for the moment there has been no indication that these issues would pose a threat to the implanted person’s safety.”
Currently testing of samples is taking place to establish if there are any health risks. Have you had Silimed Silicone implants and had problems?
The British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) “There has been no indication…that these issues pose a threat to patient safety, however we are advising our members to contact any patients who may be affected”
Are you concerned about Silimed Silicone Implants?
If you have had Silimed Silicone Implants then register your name and contact email with us to receive regular updates. We are keen to hear from anyone who has had Silimed Silicone Implants and had problems with them.
Problems may have been
- Infection soon after surgery
- Early failure rate
- Capsular Contracture
- Hot burning sensation in the breast
If you have been affected then get in touch on 0845 676 9228 or email email@example.com.
We can help
- gather information about adverse events,
- register the event with the MHRA
- claim compensation for removal and replacement (even if you have already had this done in the last 3 years) if the failure of your implant is due to the contamination of Silimed Silicone Implant.