This type of breast implant is not available in the U.S., and has been taken off the UK market. This is not because it is unsafe, but because not enough data exists to prove that it is safe. The same substance that is used to manufacture Juvaderm®, Restylane®, Captique®, Hylaform®, etc., was used to manufacture the Hydrogel-filled implant. That is, it was used as the filler in the standard silicone elastomer shell. Since the implants are not available, further discussion is unwarranted. For further information, please read the information put forth by the British MHRA (Equivalent of FAD, except for the food part).
“Hydrogel filled breast implants are no longer available in the UK.
Hydrogel breast implants consisted of a silicone elastomer shell containing hydrogel filler. Hydrogels are polymeric materials that have the ability to swell in water without dissolving and retain water within their structures.
Until December 2000, there were two models of hydrogel filled breast implants on the UK market.
Because of continuing concern over the safety of breast implants, the MDA (Medical Devices Agency, a forerunner to the MHRA) carried out a series of investigations into the safety of the various filler materials used in the implants available in the UK. The MDA’s investigations into hydrogel-filled breast implants revealed inadequacies in the manufacturers’ biological safety assessments and concluded that there was not enough information to fully assess the safety of either of the hydrogel filler materials. When they were made aware of the results of the MDA’s reviews, both manufacturers decided to withdraw their hydrogel-filled breast implants from the UK market in December 2000 as a precautionary measure, pending further studies to establish the safety of the filler materials.
It must be emphasised that no definite risk has been identified. The concern lay only with the way the safety of the hydrogel fillers had been assessed. The MHRA is continuing to monitor the safety of these implants and, based on the currently available evidence, does not recommend that women with hydrogel-filled breast implants have them removed unless they are experiencing problems.
Women who think that they may have hydrogel breast implants and are concerned, should contact the surgeon who carried out their operation, their GP or get advice from NHS Direct on 0845 4647 or in Scotland the Scottish NHS Helpline on 0800 224488.
Clinicians and members of the public should continue to report adverse incidents to the MHRA.
Information specific to each hydrogel filled breast implant:
- PIP Hydrogel breast implants were made in France and supplied in the UK by Clover Leaf Products Ltd. Approximately 4000 women in the UK received these implants since they were first introduced in 1994. The removal of these implants from the UK market was the subject of Device Alert DA 2000(07). This noted concerns about uncertainty over the metabolic fate of the filler material and about pathological changes seen in rats following implantation of the filler material that suggested the possibility of a systematic effect. The CE-marking was removed in 2002.
In May 2005 the Committee on Toxicity (COT)1 reviewed two animal studies commissioned by PIP. Although some effects were seen in the kidneys of the tested animals, in a statement (external link) prepared in January 2006, the Committee concluded that these results suggested that exposure to the hydrogel filler will not lead to toxic effects in women with these implants. There is therefore no indication for a proactive explantation programme. The Committee did, however, express concern about the lack of long-term follow up of women with breast implants.
The MHRA has received adverse incident reports of breast swelling associated with the presence of fluid in the implant pocket around PIP Hydrogel breast implants. The MHRA continues to monitor the safety of PIP Hydrogel implants and, based on the currently available evidence, does not recommend that women with these hydrogel-filled breast implants should have them removed unless they are experiencing problems. However clinicians who remove implants due to swelling (with or without suspected implant rupture) should consider having the implants weighed and photographed, carrying out histology of the surrounding capsule and cytology of any collected fluid; such cases should be reported to the MHRA.
- PIP Hydrogel breast implants were made in France and supplied in the UK by Clover Leaf Products Ltd. Approximately 4000 women in the UK received these implants since they were first introduced in 1994. The removal of these implants from the UK market was the subject of Device Alert DA 2000(07). This noted concerns about uncertainty over the metabolic fate of the filler material and about pathological changes seen in rats following implantation of the filler material that suggested the possibility of a systematic effect. The CE-marking was removed in 2002.
- NovaGold™ breast implants were made in Germany and supplied in the UK by Somatech Medical Ltd. Approximately 250 women in the UK received these implants since they were first introduced in 1996. It is estimated that around 80% of these implants were implanted by the private sector for cosmetic reasons. The removal of these implants from the UK market was the subject of Device Alert DA 2
