This is the final post from Lena on my Facebook Page. I included both a typed version (I typed it up, excuse any typos!) and a screenshot version here (grabbed from when they originally made the comment.) I can’t seem to find this comment in the hundreds of comments on my page. They may have deleted it or it may just be buried, but I thought it was important to have here on my site “for the record”! #MenstrualCupGate2018.
Note, the first image on this page (to your left if you are on a computer)is my original (unedited) post from when I initially shared the test results for their cups. My updated post can be seen in full here.
February 7, 2018
From: LENA Menstrual Cup
Please accept our apology for LENA’s earlier post – it was mistakenly posted by an employee who copied and pasted it from a customer response email and was never intended for this thread.
I wholeheartedly understand the reaction it caused and how impersonal and detached the brand LENA was made to look.
While working with our attorneys to prepare a statement and communication for Tamara (there was never any threat of “coming after” or threats of a “fight”, as comments on this thread claim,) the importance of an open letter, for all of us affected, has now become clear.
While we respect the work of any consumer watchdog such as Tamara’s, we found the initial post on her Facebook page irresponsible illustrated by the ensuing, and understandable uproar that followed. The post lacked the necessary context for such an inflammatory remark and although this may not have been Tamara’s intent, unfortunately, the result of the initial post (which was edited numerous times) led people to believe their LENA Cups were unsafe.
Even though Tamara ultimately stated she believes the levels she recorded were within “regulatory limits” the reaction caused was one of pain and anger, that LENA was at fault, unregulated and had somehow neglected our ethical responsibilities to provide a safe product.
We are great believers in the spirit of independent freedom and transparency and support any form of evaluation and research. However as advocates of any cause there is a responsibility to act with care to portray the truth especially in such divisive times where we see how quickly conclusions are made.
Cadmium is a trace element present in the environment making it necessary for an evaluation of systemic levels of this element present to be carried out in a controlled environment. No information was posted about these controls or where the cups tested came from, so naturally we are skeptical about such rudimentary home testing compared with the comprehensive laboratory evaluations we rely on.
Despite all of this, we take any such claims seriously and are looking further into Tamara’s results.
Contrary to beliefs displayed in this thread, as a Class II Medical Device, the LENA Menstrual Cup is subject to medical device regulation. Paired with our own standards and ethos we go to great lengths as a company to ensure the quality and safety of our products, developing and employing the most conscious manufacturing practices available.
In our product, the term “medical grade silicone and medical grade dyes” refers to materials that have been tested by the manufacturer for safe implantation inside the human body for up to 29 days and are batch tested for biocompatibility, which includes tests for genotoxicity. In addition, we conduct our own third party laboratory ISO 10993-1 testing on the finished products. Included in this testing is a series of replicate tests that detect any toxicity present, including that of heavy metals, at a cellular level conducted over a 30 day evaluation period – in all tests the LENA Menstrual Cup is in full compliance with all healthcare testing and regulations, however, product testing results are not intended to be shared with individuals.
We created the LENA Menstrual Cup out of a desire to offer a safe alternative period product and a passion to better people’s lives and the planet. We work each and every day to ensure that our products are accessible, user friendly and most importantly safe. We will continue to comply with regulations set by the industry and to improve as a company with the development of technology and experience.
Thank you for reading. Please feel free to contact us directly at firstname.lastname@example.org for any questions and comments.
Founder and President