The FDA's Meeting on Pelvic Mesh and the Shutdown
The Food and Drug Administration (FDA) has announced that it will hold a public meeting on the safety and effectiveness of pelvic surgical mesh. The meeting is scheduled to be held on February 12, 2019, from 8:00 a.m. to 6:30 p.m. at the Hilton Washington, D.C. (620 Perry Pkwy, Gaithersburg MD 20877) in Salons A, B, C, and D.
Of course, all of that hangs in the balance as the government shutdown continues. While information on this meeting may change, when I called the FDA this morning, I was told that the advisory committee meeting on February 12 will still be held as scheduled.
Yet, many of the women that I've spoken with as part of my ongoing project (a study on litigant satisfaction with the courts, lawyers, funders, etc. in women's heath MDLs) are too sick to travel. If you fall into that category, that doesn't mean that you have to sit idly by.
You don't have to attend the FDA meeting to make a difference.
There is strength in numbers and group attendance can, of course, send a powerful signal. That said, it's often tough to actually have a say during those meetings. The good news is that you don't have to attend to make yourself heard. Instead, take every one of the following steps, none of which requires that you set foot outside of your house. Participate in your pajamas!
1) Submit your comments to the FDA Advisory Committee by January 27, 2019.
The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee is the name of the FDA committee holding the meeting on February 12. That committee provides advice and recommendations to the FDA about the way it regulates pelvic mesh.
The FDA is creating a docket for public comment (FDA-2018-N-4395). You can submit comments that will appear on that docket and will be provided to the Committee before it meets in February.
In order to do so, you need to submit those comments on or before January 27, 2019. Comments submitted after January 27 but before February 11 will still appear on the docket and be considered by the FDA, but will not be provided to the Committee. So, submit early. Click on this link and follow the instructions given. Note that the link does not work if you try to open it using a Safari browser; use Firefox, Chrome, or Explorer instead.
When I followed the comment rabbit trail (it took a little doing to find the exact agency and comment page), I saw that only 16 comments have been received. Speak up, speak out! The link I've provides should take you exactly where you need to go without having to go through the same hoops I did.
2) Submit your comments on the litigation process as soon as possible.
I am conducting a procedural justice study on women's health mass torts like pelvic mesh. I am a law professor at the University of Georgia and am an expert on the procedures that courts use to resolve mass torts. Your comments will form the backbone of recommendations that I make to the judges handling your cases. I need to know what's working well and what might be improved.
Your identity will be kept confidential and nothing that you tell me will affect your case in any way. Nothing that I ask is covered by attorneys' "gag" orders. I am focused on your feelings about the process, and am not seeking confidential information. If you'd prefer not to include your name on the survey (which, again, would be kept confidential), you can send that to me separately via email (firstname.lastname@example.org). That allows me to confirm your eligibility to participate in the study by cross-checking court records but avoids linking your name to your survey response online.
If there are things I should know that I haven't asked about, just email me. My email@example.com address is not subject to open records act requests like my university email address is, so I suggest that you use that one, but I will receive it either way.
Make your voices heard. Take the survey. Like the FDA comment website, it tends not to work with Safari, but does work with Firefox, Chrome, and Explorer.
3) Submit adverse events to the FDA.
Patients, healthcare professionals, and manufactures can all submit reports of adverse events. Here is a link to the form you can use to submit a problem to the FDA. And here's the FDA's Q&A page.