johnson & johnson


Fresh Disclosures On Vaginal Mesh Implants

More revelations about the problems with vaginal mesh implants, which we’ve written about here and here.

Bloomberg reports that Johnson & Johnson sold one early version of the vaginal mesh product before U.S. regulators approved it:

Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device, now the subject of more than 550 lawsuits by women who claim it injured them.

J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles. The U.S. Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.
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Johnson & Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product.

The company, the world’s second-biggest health-care products maker, said it could market the Prolift without approval because it was so similar to an approved device, the Gynecare Gynemesh, Morgan Liscinsky, an FDA spokeswoman, said in a March 16 e-mail. “FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance, she said.

Back Next Year By Popular Demand: O.B. Ultras

“Back by popular demand” is an overused term, but it’s right on target this time. There were a whole lot of women who used the o.b. tampon “Ultra” size for its high-flow absorbency, and when o.b.s became mysteriously scarce late last year, and the o.b. Ultra was discontinued altogether, they made a whole lot of very public requests that the Ultra be brought back.

There is an “I want my o.b. ultras” page on Facebook, and this Website gathered more than 1500 signatures on a petition asking that the Ultra be restored. Some of the comments here on CommonHealth were heartbreaking, including concerns from women who feared they might not be able to leave the house during heavy-flow periods.

So, though I get no kickbacks from Johnson & Johnson, the maker of o.b.s, I do think it’s glad tidings that the company says it expects to get the Ultra back on the market in the second half of next year. I’d contacted them about the hilarious personal apology song they’ve posted to o.b. users, and spokeswoman Jodie Wertheim replied:

We’re glad you like the personal apology. What prompted it was our commitment to listen to the needs of our consumers and to reiterate how sorry we are for the out of stock issues we experienced this year. It’s our way of letting them know how much we value them and appreciate their support. Along the same lines, we are also in the process of re-launching o.b.® Ultra and expect to begin shipping the product in the second half of 2012.

Ever mystified, I asked if she could clarify why they were discontinued in the first place. She emailed: Continue reading

Johnson & Johnson’s Woes Go Far Beyond O.B. Tampon Shortage

Now that I’ve read this excellent New York Times piece on the big picture at Johnson & Johnson, I feel even more gratitude to their spokesperson for getting back to us repeatedly about the o.b. tampon shortage. I also feel sympathy for her; I wouldn’t want her job.

To sum up the long article, Johnson & Johnson sounds like it’s something of a general mess, with 288 million items recalled last year, including bottles of Tylenol, Motrin and Benadryl. The weird o.b. situation — sudden shortages around the country with no explanation from the company beyond “production problems” — appears par for the course.

Johnson & Johnson has had to recall such a variety of products because of quality-control problems across product lines, in multiple factories and in several units last year. Some of its consumer products, for instance, may have contained bits of metal. Others came in bottles with a moldy smell. And some products have gone missing from stores with hardly an explanation. All of this has put the company and its manufacturing under the intense scrutiny of lawmakers and officials at the Food and Drug Administration.

“It looks like a plane spinning out of control,” says David Vinjamuri, a former J.& J. marketing employee who now trains brand managers at his company, ThirdWay Brand Trainers.

And about the o.b. mystery: no further light is cast, but at least it bears a mention:

What is most perplexing is the seeming inability of executives to solve — and satisfactorily explain — the manufacturing issues that dog the company. Federal regulators have continued to fault the McNeil unit for failing to identify and address systemic problems at its plants, and consumers remain mystified about why simple products like O.B. tampons can disappear from drugstore shelves.

The Great Tampon Mystery: Where Have All The o.b.’s Gone?

o.b. update: J&J Say Stores Are Restocking; Are They? One Writer’s Tale

It’s decidedly odd. In drugstores around Boston — and apparently around the country — the shelves that normally hold o.b.’s, the no-applicator tampons, are yawningly empty. I tried CVS. I tried Walgreens. Nothing but gaps that remind me of the years I spent reporting in the old Soviet Union, with its unstocked food stores. (Some may also recall a classic Seinfeld episode in which Elaine hears that the Today contraceptive sponge is going off the market, and buys out the supply in all of her neighborhood stores.)

My crack-reporter friend, who alerted me to the situation, writes:

I called Johnson and Johnson yesterday, and they said that only the Ultra has been discontinued but the others are having some sort of mysterious manufacturing delay and will be back on the shelves eventually. What? Do they contain a secret ingredient that is only available from Somalia? Anyway, I lodged a formal, semi-crazed PMS-induced protest with J&J. They are really pissing off the wrong group of women, don’t you think?

Yes, she may be a little hormonal these days, but if anything that makes her more dogged. She adds:

After being unable to find them at any normal place, I checked, etc – no dice. Then I went on Amazon and eBay, because I thought maybe there was just a weird shortage in MA. So yesterday they were $75+ a box and when I called J&J the lady told me that she had seen them on ebay for $130. That’s more than $3 a tampon! J&J lady also told me they were getting “a flood” of complaints. No pun intended! Ha ha.

Naturally, I had to take up the baton from her. First, it’s just strange. Second, o.b.s are not just tampons. They’re iconic, representative of the branch of the feminist movement that encouraged women to become comfortable with their own bodies. (Because o.b.s have no applicator, women need to get a little more intimate with themselves when inserting them.) And they’re appealingly no-frills, adding no applicator plastic to the landfills. When a blogger on the Jezebel site bemoaned the discontinuation of the Ultra, many other users chimed in, agreeing.

I have a call in to the Johnson & Johnson spokeswoman who handles the o.b. brand. I checked with the Consumer Product Safety Commission to see if there had been a recall, but they sent me over to the FDA, which determined that tampons are considered a medical device. Still waiting to hear back from them. Please stay tuned.

(And here’s an update: No official word yet, but reports of empty o.b. shelves nationwide.)

And yet another update here.