Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 25 September 2015 | By Zachary Brennan
Two days since the UK's Medicines and Healthcare products Regulatory Agency (MHRA) halted all sales of Silimed's silicone implants, and at least two other regulators have followed suit, while Silimed insists its devices are safe and has criticized MHRA's criteria for particle levels.
MHRA on Wednesday suspended the CE certificates of the Brazilian device manufacturer Silimed, which claims to be the largest manufacturer of silicone implants and the largest breast implant manufacturer in South America, following the inspection of a German notified body, which found "surfaces of some devices were contaminated with particles."
The British Association of Aesthetic Plastic Surgeons and British Association of Plastic, Reconstructive and Aesthetic Plastic Surgeons said in a statement: "Plastic surgeons have been informed not to implant these devices until furtherassessments have taken place and the CE Mark reinstated - we are not aware of any documented patient safety issues."
Australia's Therapeutic Goods Administration (TGA) on Friday said it received information from the Australian sponsor of Silimed implants that the unknown particles have been identified as silica and cotton.
As a precautionary measure and in consultation with the TGA, the Australian distributor of Silimed's products, Device Technologies, has been contacting surgeons who have been supplied with these implants to postpone any planned implant surgeries. Device Technologies also ceased supply of all Silimed products until the situation is clarified.
A list of effected products includes not just breast implants, but chin, ear and muscle prostheses, as well as gastric balloons.
TGA, like MHRA, said there has been no indication that these issues would pose a threat to the implanted person's safety.
Similarly, Swissmedic on Thursday issued aprovisional recommendation not to useimplants from the company.
Silimed acts as a contract manufacturer for US breast implant supplier Sientra, which sent a letter to plastic surgeons on Thursday notifying them that its breast implants continue to be marketed and available in the US and that the MHRA suspension does not indicate that the contamination issues pose a threat to patient safety.
"Silimed has been audited multiple times by the FDA to ensure compliance with the Quality Systems Regulation, and has, to date, never received a 483," Hani Zeini, CEO of Sietra, said in the letter.
Despite the letter trying to calm the nerves of surgeons, investors seemed scared by the MHRA suspension and Sientra's stock fell by more than 53% on Thursday. Stifel Financial analyst Jonathan Block said in a note to investors that the MHRA inspection was from earlier this month and FDA hasn't inspected the site since 2003.
"The draconian reaction from the regulatory authorities (suspension of CE) is confounding to us, but we believe the sensitivity surrounding the product (women's breast implants) and the European authorities past stumbles with oversight (PIP) may be playing a role in the process," Block said.
Silimed, meanwhile, said in a media announcement emblazoned across its website that "there is no contamination of its products," though it voluntarily suspended the sales of its products on the EU market until health authorities issue an official technical report.
The company also criticized MHRA's criteria for determining what level of particles should cause a regulator to suspend sales of a product. In Europe, "there is no criteria that defines levels of particles, which can lead to an absolutely subjective analysis," Silimed said.
"The level of particles found is extremely low and complies with all of the markets, as is the case of Brazil where the products are tested randomly in the market by accredited organizations," the company added.
It also claims that the presence of a minimum level of particles is common in all medical products – including silicone implants of other brands and available on the market – without necessarily meaning that there is a prospect for damaging a patient's health.
Tags: MHRA, Silimed, plastic surgery, breast implants, silicone implants
Regulatory Focus newsletters
All the biggest regulatory news and happenings.