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United Kingdom MHRA Warns Against Lipostabil® and Malpractice Insurers Stop Coverage

FDA Statement: “Lipo-dissolve is not FDA approved for any use...we are not aware of any [PC] or [DC] injectable products that could be used off-label in lipo-dissolve procedures”

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Phosphatidylcholine-based injections (Lipostabil®) are not approved for cosmetic use in the United Kingdom. Accordingly, the Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a consumer warning stating that the product is being unlawfully advertised for cosmetic fat removal as it has not been assessed in clinical trials for this purpose.

The Medical Protection Society, which provides malpractice coverage in the United Kingdom, withdrew coverage from all United Kingdom physicians using phosphatidylcholine for cosmetic fat removal. The change in policy was based upon the UK Medicines and Healthcare Products Regulatory Agency's warnings against its use, and represented the first time such a withdrawal in benefits was implemented.

PDF Link: United Kingdom Medicines and Healthcare Products Regulatory Agency

PDF Link: Medicines and Healthcare Products Regulatory Agency Q & A

PDF Link: United Kingdom insurers

ASPS Warns Against Injectable Fat Removal Treatments >>>