BDDE in Restylane

Does the BDDE that is in restylane break down in the body?

Doctor Answers (1)

Safety of BDDE in Restylane

+2

You must have read that BDDE (1,4-butanediol diglycidyl ether) may cause cancer in mice. In fact BDDE MAY have been associated with tumor formation in mice following topical application in ONE study.

allow me to quote from the FDA paper Cancer Risk Assessment P020023 quoted below
"Since negative results were obtained in the mutagenicity studies of Restylane, and since the estimated excess cancer risk is in the range determined to be acceptable for compounds released from medical devices (based on ISO 10993-17), it is unlikely that BDDE-associated carcinogenic effects would be observed in patients who receive this product...

SUMMARY

Use of the first approach yields a total lifetime dose of BDDE associated with 10-6 excess cancer risk in mice of 1 ug/kg. The equivalent human dose (assuming surface area scaling) is 0.08 ug/kg. In comparison, the total estimated dose of BDDE received by patients treated with Restylane is 3 ug/kg. This dose is equivalent to an excess cancer risk about 4 x 10-5. In other words, the total (presumably upper-bound) risk of BDDE that could be received by a patient undergoing treatment with Restylane is about 4 in 100,000. This risk is generally considered to be acceptable for compounds released from medical devices using the criteria outlined in the ISO 10993-17 standard. In addition, negative results were obtained in the mutagenicity studies of Restylane, providing further support to the conclusion that BDDE-associated carcinogenic effects are unlikely in patients who receive this product.


The second approach was used to derive a Lifetime Average Daily Dose (LADD) associated with a 10-6 excess cancer risk from BDDE. Based on the data from the mouse carcinogenicity study, the LADD associated with 10-6 excess cancer risk in humans is 1.27 x 10-5 mg/kg/day. If the total dose of BDDE from Restylane is averaged over a 70 year lifespan, the LADD for patients is 1.2 x 10-7 mg/kg/day, a dose that is about 2 orders of magnitude less than the LADD associated with 10-6 excess cancer risk. Either approach suggests that the cancer risk from exposure of patients to BDDE in Restylane is minimal."

Restylane has been used in millions of people the world over with a great safety record. But, if you absolutely feel uncomfortable with this then you should not be using this or other products containing it.

Dr. Aldea


Memphis Plastic Surgeon
5.0 out of 5 stars 60 reviews

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.