FDA Calls for 'Cautionary Approach' on Brazilian Manufacturer's Suspended Implants
Posted 14 October 2015 | By
The US Food and Drug Administration (FDA) told RAPS' Regulatory Focus that it concurs with breast implant provider Sientra's caution in voluntarily placing a temporary hold on the US sales of all devices from Brazilian implant manufacturer Silimed.
"We concur with Sientra’s recommendations to take a cautionary approach until more is known, and we are actively working with the company and other international regulators to investigate the issue. The FDA is in close communication with the EU and Brazilian authorities as more information is gathered," FDA spokesman Eric Pahon told RAPS.
He also added that FDA "is not aware of any adverse patient events related to the current matter under investigation."
The comments come as Sientra, the largest distributor of Silimed-made implants in the US, last week told surgeons it was placing a temporary hold on the US sale of all such devices. The breast implant provider also recommended that plastic surgeons stop implanting these devices until further notice, though it stopped short of calling for surgeons to remove Silimed implants.
MHRA, Brazil Action
Sientra's caution follows the UK's Medicines and Healthcare products Regulatory Agency's (MHRA) suspension late last month of all CE certificates for Silimed medical devices after German inspectors found particle contamination in some devices made at the company's manufacturing plant in Rio.
Silimed manufactures a catalogue of more than 5,000 implants for plastic surgery, bariatric surgery (including gastric bands and balloons), urology, general surgery and other invasive silicone devices in more than 75 countries.
Following that suspension, Australia's Therapeutic Goods Administration and Brazil's National Health Surveillance Agency (Anvisa), which actually inspected the Rio facility from 28 September to 30 September, also suspended sales of the products.
Silimed, meanwhile, claims that the suspensions are arbitrary as "there are no technical specifications regarding the level of particles" in Europe or elsewhere for implants.
FDA's Pahon told RAPS that there "are standards for breast implants; however, these do not include limits for particles. Manufacturers are required to have robust quality management systems that assure the quality of their products."
The company also points out that "the technical literature, the risk analysis and also the post production surveillance show that over the years the presence of sterile particles (which are not micro-organisms), is common to all medical devices, and does not reveal any risk to patients' health."
Sientra Letter to Plastic Surgeons