In a move called “stupid and unfair” by Blanche Delacourt of Zephyr Surgical Implants (ZSI), Health Canada will not be allowing surgeons in Canada to implant the ZSI erectile prosthesis for transgender men. This has placed over 26 transgender men at GRS Montreal alone in limbo. Though ZSI’s FTM 100 and FTM 475 implants, designed specifically for transgender men, are not approved for use by Health Canada, they had previously been permitted through Health Canada’s Special Access Program (SAP). GRS Montreal previously made use of this exemption for 3 transgender men in 2018 and 1 in 2016. However, when they requested SAP for a further 26 patients, Health Canada refused.
Understandably, this has had a devastating impact on some transgender men waiting for placement of the ZSI device. Keenan Pinder, for instance, has been “waiting for 3 years for Health Canada to approve [the device, which he feels] is a far superior implant and the only one of its kind made specifically for trans male anatomy”. Pinder, like other transgender men in his situation, is now left in a position of having to choose between the placement of an older device he doesn’t want, and travelling to Europe to have a ZSI implant, which he cannot afford.
When reached for comment, Health Canada explained; “Canada’s Medical Devices Regulations contain some of the most stringent requirements anywhere in the world. [ZSI] would require a Class III medical device licence [Class IV is the highest] in order to be sold on the Canadian market, [which they do] not have”. While they previously had approval for the ZSI 475 device for cisgender men from November 2013 to December 2017 they require additional approval for the FTM 100 and FTM 475. “The SAP… provides access to non-marketed products… when conventional therapies have failed, are unsuitable or offer limited options. In 2018, [Health Canada] authorized three [ZSI]… Implants. However, the Department has become aware of a 2019 study on this new device [that] reported post-operative infection rates of 14%, which is more than three times higher than what is reported using currently licensed penile implant devices (4%)… and has concluded that the risks of this new unlicensed device outweigh the potential benefits.”
Health Canada further clarifies that receipt of GRS Montreal’s request for SAP approval of an additional 26 implants spurred their investigation and resulted in the refusal. However, they also note that practitioners interested in using the implant can still request an Investigational Testing Authorization in order to place them in the context of a “supervised clinical trial setting… [This would put] appropriate safeguards in place to protect the health and safety of patients… and help to generate the necessary clinical information and data which would allow for the assessment of the safety and effectiveness of the device, potentially in support of a future licence application.”
Nevertheless, Health Canada stressed that they assess all applications individually and make decisions “based on the evidence provided by the physician for each individual patient” and are open to future applications that “demonstrate a different risk-benefit assessment”. They have provided GRS Montreal with this information, guidance on navigating this process, and encouragement to “have [ZSI] apply for an Investigational Testing Authorization”, which would take approximately 30 calendar days. They have not, to date, received an application for this.
GRS Montreal has released public statements, on April 12 and April 25, 2019, addressing this matter. The first confirms Health Canada’s refusal to allow SAP authorization for the ZSI device, that future surgeries using the device have been cancelled, and that they are exploring the possibility of an Investigational Testing Authorization. In the meantime GRS Montreal will be offering the AMS Ambicor and Titan OTR implants, which are approved by Health Canada.
GRS Montreal further clarified, in their second statement, that Health Canada is requiring ZSI to prove the viability of their device through a study that follows patients over a longer period of time than the existing study and that “an experimental trial of this magnitude for an implant used in less than 600 surgical procedures per year worldwide will result in exorbitant costs for [ZSI, which would]… greatly compromise the [company’s] sustainability”. They add that Canadian Provincial health care programs “will not authorize… payment of a device… not approved by Health Canada… [and] may not authorize… [an] implant or… surgical procedure if this implant is used in an experimental trial”.
When reached for comment, GRS Montreal confirmed the above information and specified that they believe their “26 applications for approval [which] was an attempt to clear up [a] back log [of 124 patients] triggered… Health Canada’s [decision because] the regulations do not permit batch applications [and that] Health Canada.. requires [ZSI] to apply for an [Investigational Testing Authorization]”.
ZSI, for their part, has requested that the LGBTQ+ community speak out in response to this decision. When spoken to for this article, they indicated that they were working actively with GRS Montreal to address this issue, but seemed perplexed by the development. Their head of Research and Development, Dr. Christopher Llorens, with whom I spoke during EPATH in Rome, opined that Health Canada’s registration requirement may be an attempt to extract $20,000/per device and yearly upkeep in registration fees. He also indicated that medical device regulations had recently changed between Canada and Europe, whereby previously devices accepted in Europe were granted access to the Canadian market. When asked on their Facebook page* whether the “devices [could] be purchased by individuals and… implanted by surgeons in private clinics in Canada” ZSI invited those interested in doing so to get in touch with them, though they allowed that many surgeons won’t “agree to implant [an unapproved device and that it can” be rejected at border.
*This article was updated on June 2, 2019 to refresh a link.