That really sucks that the implants failed. IANAL, so haven’t got any advice about that, but do have a suggestion for home help. Could you not advertise at your local college for a student looking to make some extra money? A lot of kids have younger brothers or sisters and can be very good at helping out with your kids while you’re on bedrest and they shouldn’t cost all that much. If you have an extra room in your house, you could even get them to do it for room and board. It sucks that you have to go through this but I’m wishing you the best of luck and hope that you have a happy outcome.
So the 2 weeks they spent in the board room last year looking at raw data notebooks, analytical reports, chromatograms, system usage logbooks…none of that counts? I’m not a huge defender of the FDA (nor do I oppose them, really) but this comment just simply isn’t true. They don’t do their own assays or clinical trials, but they DO audit all information about a drug applying to go to market amd can and DO withhold a drug from market if things just don’t add up. Where I work, we are audited by both the FDA and the HPFBI (Canadian equivalent), not to mention the individual drug makers themselves (a near weekly occurance). Falsifying data is a CRIMINAL offence. Getting caught can not only mean the drug gets pulled, but it can and HAS lead to the shutdown of companies. Maybe there’s more corruption that I know of, but at the basic level, quality controls are really strict and it’s taken VERY seriously.
BTW - I work for a company that does development and manufacturing work on over 250 different drug products. Audits are pretty common. Product failures are not merely brushed aside. I understand your skepticism, but even regulatory controls are not 100% effective. “No pregnancies in 2 years” likely means exactly that…that doesn’t mean that no one got pregnant the day after the study ended, it means no one got pregnant during the study. Medicine has it’s risks.
Well, it does feel rather as though THIS particular product failure is being brushed aside. Having a nurse - not a radiologist, not a doctor - look at the X-rays from my HSG and opine that the implant is not in the tube at all, but has perforated my fallopian tube and is currently floating around in my peritoneal cavity…and I’ve had no pain requiring so much as a Tylenol in 18 months…as well as simply ignoring the fact that I passed my HSG with flying colors - seems a whole lot like ignoring a product failure.
Personally, I’d think they’d be very interested in what made it fail in my case. Was it something to do with my DES exposure in-utero? That would be important to know. A lot of women my age were exposed to DES. Could it be that the HSG is inadequate to assess tubal occlusion? Could a percentage of women resorb their own scar tissue? That would be useful to know. Could silent perforation take place, and if so, what are the risks of that? But as far as I can tell, my case has simply been dismissed. And I am not impressed.
I work for a medical center in research, and our department does new drug/device testing. Recently we were eligible for a FDA audit - the drug in question was being pushed for marketing, and the FDA requested the info on all the sites involved in the research, and randomly selected sites for audits. We weren’t chosen as a site, but if we had been, we’d have had them poking around all of our study records, checking out the charts, talking with everyone involved, examining our facilities, and so forth.
Ok, fair enough. Maybe the whole “FDA doesn’t check up on anything” was pushing it, and I defer to those who know more about it than me.
But after Phen-Fen (which I didn’t take, in case you’re wondering), I’ll never again totally trust their judgment, or your average pharmaceutical company. Do most of them do their best? I’m sure, but there are some awfully crooked people out there, too – and they don’t care if a few dozen people keel over as long as their profits outweigh the cost of a class action lawsuit.
If you’re absolutely against the idea of hiring your own lawyer, even to scare them into a settlement, at the very least use your google-fu to keep checking back over the next couple of years for any class-action suit that may develop. Or, if you see individual suits going forward and being successful, that may make you change your mind about the appropriateness of suing the company.
Add Serzone (an anti-depressant) and Vioxx (an anti-inflammatory) to the list of drugs that have been released and subsequently pulled due to causing severe health issues. I’m not sure exactly how drugs are released for people to use and then withdrawn when they are shown to be dangerous; I don’t know how these things happen, but they obviously do.
If you’re up for it, Chotii, (and I would understand completely if you weren’t), I would push the manufacturer to the wall on this one. Their product did not do what it was supposed to do, and the repercussions are pretty darned serious - they need to find out why.
I guess there isn’t anything to pursue. It appears that this littlie is only passing through.
Better luck next time, littlie. Maybe you’ll find a family who’s been trying desperately for years, and wouldn’t have to crowd you into a 3-bedroom house with 4 other siblings.
Oh, Chotii, I’m so sorry.
Sigh. Well, Chotii, you’ve handled this whole thing with grace. It’s probably been an emotional rollercoaster, and I hope you take some time for yourself to reflect and process. Damn near impossible with 4 kids to care for, but important.
Take care.
Chotii, I’m sorry.
Chotii:
Your mom’s an idiot. I’m glad the daughter came out better 
Best wishes for you, Chotii-hubby and all the Chotii-kids.
Around here, Caritas has “visit the sick” services. You don’t have to be a Catholic or poor to get it, you just have to be someone who needs help and asks for it. It doesn’t attempt to cover the need completely but it can mean a lot. When my parents were depressed at the same time, Mom bedridden, me in 11th grade and the boys in 3rd and 5th, two friends of Mom’s would come by about 4 hr/week total and it was incredibly helpful (it’s been 20 years and I still can’t cook veggies right to save my life). Maybe there is something similar in your area?
Ouch. Just read the part I’d jumped over before.
Hugs all around.
Chotii, I’m sorry.
My sympathies to Chotii and her family. Sometimes things in life just happen.
My prayers and sympathy are going out to the Chotii family. 
I’m sorry, hon.