posted previously on the Edwards SAPIEN heart valve operation recently carried out at the National Heart Centre. It seems that the Edwards Lifesciences company has been getting into all kinds of problems recently also with respect to their Myxo annuloplasty ring. (Online references at the end of this post)
Essentially, the problem was triggered by the complaints from one patient at the Northwestern University research hospital, who claimed that the valve that was inserted into her heart in 2006 was not a FDA approved device, and she was not made aware that it was an experimental option. Furthermore, the surgeon who operated on her was an inventor of the valve and also received royalties from the marketing of the device. The fallout from her complaints have been significant and protracted. Although the university has denied any wrong doing, the patient's position has been supported by another of her doctors at Northwestern.
The background information, very simply outlined here, about this saga, are as follows:
a] In 2001, the FDA apparently rubber-stamped the industry's petition to reclassify heart valve annuloplasty rings to a lower risk category so that it can qualify for the 510(k) regulatory loophole. This meant that the industry can avoid doing clinical trials of an innovation if it can be shown to be insignificantly different from an earlier invention. Edwards Lifesciences used this loophole to launch their Myxo annuloplasty rings, even though they had filed for patents documenting significant differences from older versions.
b] Consequently, at the time the patient received the implant, the FDA did not even know of its existence. The FDA says it therefore never gave any approval. If it is an unapproved device, it should be regarded as an experimental device. The company and the university says it is not experimental, and that it did not require FDA approval under the 510(k) loophole. Meanwhile the surgeon has published the data as part of a clinical study.
The controversy continues to brew and has provoked cries for the FDA to review its approval procedures for medical devices.
Further readings here:
What have all these got to do with us here in small, faraway Singapore?
For starters, we should not be too over-reliant on decisions made by FDA, and should develop our own opinions on the matter. This is not to say we have to duplicate all the evaluations, but merely we need to scrutinize all innovative medical devices to form our own opinion as to how much pre-marketing data is required. The FDA is wrong to say "... companies, not the agency, are best qualified to determine whether modifications affect a device's safety or effectiveness." Companies are motivated by self interest. Mostly of the commercial sort. Interestingly the HSA has a pdf file on this Myxo ring, but the file is mysteriously not accessible.
Secondly, doctors do not have the inalienable right to stick all kinds of experimental devices into patients with firstly getting ethics approval, and regulatory approval. It is unclear how many similar annuloplasty rings have been used on our patients without notification and approval of the HSA, or even ethics committees. It remains unclear whether the previously blogged about SAPIENS tricuspid valve prosthesis was approved by the ethics committee as an experimental procedure, since it was not an approved medical device.
Thirdly, proper informed consent by the patient is required. Gigamole notes the favorable developments recently to develop better informed consent procedures. This has been long overdue. Gigamole hopes that the consent process will make the distinction between routine accepted practice and experimental procedures using methods that have not been approved by the HSA. Patients are not all willing to be guinea pigs.
Just a parting trivia...... The company Edwards Lifesciences makes exciting new valves here in small faraway Singapore. Their factory in Changi North Crescent, opened in 2008.
5 years ago