My Lords, I will speak briefly in support of Amendment 84 in the name of the noble Baroness, Lady Finlay. I also wish to raise a question on Amendment 97 in the names of noble Lords, Lord Kakkar and Lord Patel, and to ask the Minister a question on equivalence, of which I have given him notice.
During my review, we heard much that greatly concerned us about the way that medical devices reach the market. Our focus was on pelvic mesh, but similar concerns apply to devices more generally. When mesh for stress incontinence and pelvic organ prolapse first came into use, the safety data available was woefully inadequate. It relied on very short-term studies, often funded by manufacturers with vested interests, with limited follow-up. Mesh is a product that is designed to remain inside the body, which presents a problem, because it is designed not to be removed. Removal can be done, on rare occasions, but it is very difficult and dangerous. Implanting a device such as this into so many patients with such a lack of safety data is, as we said in our report, foolhardy.
I recognise that some risks of new treatment options may become apparent only when they have been in use for some time. I agree with the noble Lord, Lord Hunt, that surgeons need to be able to offer new, innovative treatments. That is how medicine has made such tremendous progress in our lifetimes. We must not stifle innovation, but we must do all we can to improve patient safety and to prevent avoidable harm. We had a full discussion of this on our previous day in Committee.
In clinical trials of medicines all adverse events are reported, whatever their cause, and that is good. In the case of mesh, if selected cohorts of patients had undergone enhanced reporting, it is most likely that the adverse impacts we heard about would have been detected sooner. Thousands of ruined lives, in this country alone, could have been avoided.
In the field of medical devices, better, more thorough trials with long-term follow-up are vital, but they are not the whole answer. We also need transparency. It is one thing for trials to be conducted, but quite another to ensure that the findings they produce, and the concerns they may give rise to, are made available to the public and to potential patients. Patients have the right to know about trial outcomes and safety concerns that arise in trials. They have the right to know who is conducting the trial and who is funding it. Without that knowledge, there cannot be an informed decision about an individual’s treatment options.
Many common themes arose during our review, but one that is particularly powerful, and relevant to today’s discussions, is the phrase that so many women with terrible mesh complications used. They said to us: “If only I had known”. If only they had known the risks, perhaps they would never have had the procedure and their lives—and those of their families—would not have been ruined.
This amendment would ensure that medical device trials are entered on a publicly available database and would bring devices into line with medicines. This is much needed, which is why I support the amendment.
I turn to Amendment 97, proposed by the noble Lords, Lord Kakkar and Lord Patel. One of the issues that we encountered during our review was that the full safety implications of an implantable medical device may become obvious only once the device is inserted. Some women told us that they sensed immediately that something had gone wrong; for others it was not until years later. Trials need to be sufficiently long term to detect safety concerns some years after the device is implanted.
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However, discovering safety issues once patients have had the device implanted is actually very difficult. It means that patients are, in effect, the guinea pigs. Those are the very words many women with mesh complications used when we discussed their problems; they told us, “We are used as the guinea pigs”. So I am keen to understand whether and, if so, how the use of a provisional licence might address this dilemma. I would be grateful to the noble Lords, Lord Kakkar and Lord Patel, if they would help my understanding of the issue.
Finally, I am also concerned about equivalence. We heard much during our review about medical devices. These devices were able to claim equivalence to an existing product and thus gain, in effect, automatic authorisation without any approval process. The equivalence arrangement is rather like a chain reaction. If a second product successfully claims equivalence to the original product, it may well be slightly different in composition or intended for a somewhat different use, yet it gains the ability to be marketed for the same purposes as the first product. A third product then comes along and is somewhat similar to the second, so it gains equivalence status, yet its composition or intended use is further removed from that of the original authorised product. So it can go on, and the products claiming equivalence can bear little relation to the original product. This can give rise to serious safety concerns. With that in mind, I ask my noble friend the Minister: how do the Government intend to approach the matter of equivalence in the field of medical devices once the Bill is enacted? I have given him notice of my question.