Silimed are a company which is based in Brazil which manufactures breast implants that are sold all over the world. Last week, the CE marking authorities in Europe suspended the CE mark for these implants after an annual review of the manufacturing process. As a result, the MHRA in the UK advised that these implants should be withdrawn from use until further notice.
Why have Silimed implants been withdrawn from use?
These breast implants have been withdrawn from use because the relevant authorities require clarification about the manufacturing process following a recent inspection which occurred in September of this year. A CE mark is required since it means that the product has to comply with a European Conformity of standards. A regular inspection is required to maintain the CE mark and without a CE mark the implants cannot be used in Europe. As a result of this the MHRA in the UK have also suspended the use of these implants in the UK. However, the MHRA have stated that there is no concern related to patient safety.
What is the specific issue which relates to a withdrawal of the CE mark?
The CE marking authorities have raised an issue relating to a small level of particles found in the implants. The exact nature of these particles is yet to be clarified. Silimed maintains that all breast implants contain a very low level of non-silicone particles but in Europe, this level has not been defined and that this is the matter that needs to be clarified. Silimed maintains that they voluntarily withdrew the implants from the market and that they are in the process of compiling a technical report which will be submitted to the European authorities.
What type of Silimed implants are affected?
Silimed produces numerous types of silicone implants including breast implants, pectoral implants, buttock implants, calf implants and other silicone products used in other surgical disciplines. They are particularly known for their breast implants where they manufacture standard textured silicone implants but also polyurethane-coated breast implants. The latter has a silicone gel which is coated with a polyurethane foam which reduces certain complications of breast implants such as capsular contracture and rotation. All silicone products have been withdrawn from use.
What is unclear is that the manufacturing facility has been inspected several times in the last 10 years by the FDA and also within the last two years by the European Authorities and hence any potential adverse issue, if any, related to implants is likely to only involve recently manufactured implants.
Is this situation similar to the PIP implant problems?
This situation is entirely different to the PIP implant problem. With PIP implants the company had committed fraud by deliberately altering the manufacturing process and hiding this from the authorities. There were concerns that the silicone gel was substandard and implants had higher rupture rates due to some instances of implants having a weak shell. There is no indication that the Silimed implants have silicone which is substandard and there are no reports of higher rupture rates. Also, the PIP company went into liquidation which meant that breast implant warranties were void. In the current Silimed situation the company is fully compliant with the authorities and voluntarily suspended the sale of the implants from the European market. Their statement can be read below.
Is there a concern related to patient safety?
The MHRA has issued a statement stating that currently there is no patient safety concerns. There is no indication to exchange or remove implants and no medical attention is required.
Have Silimed issued a statement?
The statement from Silimed can be read as follows :
September 17, SILIMED Industria de Implantes Ltda., a major Brazilian company specialized in silicone implants, was questioned by the European certification agency, regarding its criteria for particles. The company immediately responded to European sanitation authorities and is providing technical documentation to prove the safety of its products. The presence of a minimum level of particles is normal in all medical products – including other silicone implants available on the market – with nothing indicating a risk to health. The presence of particles does not mean that the product is contaminated.
SILIMED voluntarily suspended the sale of part of the product on the European market, until local health authorities have received the official technical document. The company stresses that an analysis of the literature and of the criteria for the presence of particles has not shown any data regarding risks and that, since 1998, it has maintained the Post Market Surveillance index among the standards required by the legislation currently in effect.
SILIMED also clarifies that the questioning is exclusively connected with the guidelines of the sanitation policy of the European Community and that it complies with the other regulations in effect in other markets. The company informs that this situation does not indicate a need to exchange implants or to have additional medical attention.
Regarding the press release published by the Medicines & Healthcare Products Regulatory Agency - MHRA - yesterday, September 23, SILIMED clarifies that:
To date, there is no technical report showing that the SILIMED products should be removed from the market.
The company voluntarily suspended the commercialization of the products in the European market until the local health authorities receive their official technical report.
All SILIMED products are produced in compliance with the highest standard of safety and subjected to tests to demonstrate its sterility in all batches. The presence of a minimum amount of particles does not mean contamination.
The presence of a minimum level of particles is common in all medical products -including the remaining silicone implants on the market.
The particle level found is extremely low and complies with all markets in which there are pre-defined criteria, such as Brazil, where the products are tested randomly on the market for accredited bodies (Inmetro).
In the European community, there are no criteria defining particle levels, which can lead to an absolutely subjective analysis.
The company has been producing technical reports to prove the complete safety of their products.
A risk analysis has been endorsed by Dr. Wanda Elisabeth, coordinator of Silicone Commission of the Brazilian Society of Plastic Surgery and one of the leading experts on the subject.
SILIMED is a Brazilian company manufacturing silicone implants, been on the market for 37 years in the market, and is approved in 75 countries. It is an industry leader, the third largest manufacturer of the type of products in the world and a reference in the global market for innovation and quality. To date, the company has no record of occurrences of this nature.
Any interpretation of the subject by the press may result in irreparable damage to SILIMED who always ensured the complete security and quality of its products.
The SILIMED make themselves available for any further information needed, through the agency Kreab SA.
Have other countries suspended use of Silimed products?
Silimed products have been suspended from use in all European countries and also in Australia. However, they continue to be used in the United States where the branded product is called Sientra and which is FDA approved. At the current time, the FDA has not suspended the use of Sientra breast implants and these implants continue to be used in the United States.
What is the relationship between Silimed breast implants and Sientra breast implants in the United States?
Sientra is a brand of breast implants marketed in the US by the same manufacturer of Silimed breast implants. Therefore, Sientra implants are manufactured in the same facility as Silimed implants. The facility has been inspected by the FDA ( the US licencing authority) several times in the last 10 years and no problems have been found. In fact Sientra is the only product to have FDA approval for anatomically shaped implants in the United States. The FDA have not withdrawn use of Sientra breast implants in the United States.
Sientra has made a statement to their Plastic Surgeons in the US which reads as follows:
Dear Valued Plastic Surgeon,
I wanted to comment on some industry news that we became aware of yesterday. The Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the United Kingdom Department of Health, announced the suspension of Silimed’s CE certificate for all medical devices made by Silimed. Notably, the MHRA stated in its announcement that “there has been no indication at this time that these issues would pose a threat to patient safety.”
As you may know, Silimed is one of our contract manufacturers. Please note that the MHRA announcement has no applicability to Sientra’s products as it is applicable only to the distribution of Silimed’s CE-marked implants in Europe. Our products are FDA-regulated and PMA-approved. Sientra’s breast implants and our other products continue to be marketed and available in the United States and there has been no change to the regulatory status of Sientra’s FDA-approved breast implants.
We are confident in the safety of our products, and you can reassure your patients as needed by telling them that there has been no indication that these issues would pose a threat to their safety. In light of this news, we will, of course, conduct our own review to ensure continued compliance with our own high internal standards.
A few other important items to note:
Silimed has assured us that they are working with the MHRA in the European Union to resolve the issues promptly; and 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 observation. Silimed has also been audited by ANVISA and other Brazilian regulatory authorities.
Our recent publication of our clinical data at 8-years of follow-up supports our continued record of safety and efficacy.
Given our unwavering commitment to you and your patients, I will continue to keep you fully informed.
In the meantime, and as always, I am available along with my team to address your needs and inquiries. Please do not hesitate to contact us via our information request line at firstname.lastname@example.org, or by calling us at 888.708.0808.
Founder and Chief Executive Officer
What will happen next?
Silimed is actively working on producing a technical report to satisfy the relevant authorities that the products are safe and compliant. Once this has been verified and once the CE mark has been re-instated Silimed representatives are confident that the products will be back on the market. This is an on-going situation and the MHRA will provide regular updates.