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[Birdbomb]

This recall was a long time coming but can't help from wondering if the article pushed it a bit.

http://www.nytimes.com/2010/08/27/business/27hip.html?adxnnl=1&partner=rss&emc=rss&adxnnlx=1282901054-I91ZK0+Wz1D9PsELtlRYiQ

Johnson & Johnson Recalls Hip Implants
By NATASHA SINGER
Published: August 26, 2010


More than two years after the Food and Drug Administration began receiving complaints about the failure of a hip replacement implant made by the DePuy Orthopaedics unit of Johnson & Johnson, the company said Thursday that it was recalling two kinds of hip implants.
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Rush Photo

Dr. Joshua J. Jacobs said medical centers had already noticed a high failure rate for the DePuy Orthopaedics hips that were recalled Thursday.

DePuy said that it had made the decision to withdraw the products because many patients required a second hip replacement after the company’s implants had failed.

The news compounded problems for Johnson & Johnson, which has recalled a succession of some of its best-selling and best-known products, including liquid children’s Tylenol in the United States and, just this week, Acuvue contact lenses in Japan and other countries in Asia and Europe. The Tylenol recall led to the temporary closing of a plant owned by the McNeil Consumer Health Care unit, which is the subject of a federal inquiry over its handling of recent recalls of over-the-counter products.

In addition to DePuy’s recall, the F.D.A. this week criticized the company in a warning letter, contending that it had illegally marketed an unapproved knee device and had also sold a hip implant for an unapproved use. (A spokeswoman for DePuy said that the company was examining the F.D.A.’s concerns.)

“All this makes it seem like it’s pile-on time for J.& J.,” said William Trombetta, a professor of pharmaceutical marketing at Saint Joseph’s University in Philadelphia. “This is a company that was purer than Caesar’s wife, this was the gold standard, and all of a sudden it just seems like things are breaking down.”

In the latest Johnson & Johnson case, DePuy said in a statement that it was recalling two products: the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur, a method intended to preserve more bone. The traditional implant has been available worldwide, and the resurfacing implant was approved for use in countries outside the United States.

About 93,000 of these devices have been implanted worldwide, said Lorie Gawreluk, a DePuy spokeswoman. The New York Times reported in March that for more than two years, the F.D.A. had been receiving complaints that the devices failed early in some patients, requiring expensive and painful operations to put in new hip replacements. Since the start of 2008, the F.D.A. has received about 400 complaints involving patients in the United States who received the devices, an agency spokeswoman said Thursday.

DePuy said that the majority of hip replacements using the ASR devices had been successful. But the company advised patients who had had hip replacements with the recalled products to visit their surgeons for an evaluation and annual monitoring. The company said it would pay reasonable and customary medical costs associated with the recalled products, including new hip replacement operations.

DePuy had sales last year of about $5.4 billion, according to a Johnson & Johnson earnings report.

The high early failure rate of the ASR implants was reported this year in severalarticles in The New York Times. These devices have come under scrutiny over the last few years because they are part of a category of implants called metal-on-metal bearings, which can generate debris from wear, causing inflammation and tissue damage in certain patients.

In March, the British agency that regulates medical devices issued an advisory on metal debris generated by hip implants. A spokeswoman for the F.D.A. said the agency was planning to meet soon with professional medical groups to discuss the British advisory.

Late last year, DePuy said it was phasing out the implants because of slowing sales. In March, the company warned doctors that the implants might have a high failure rate in some patients.

In one New York Times article, some orthopedic experts expressed dismay that DePuy had not halted sales of the devices earlier. About 12 to 13 percent of patients needed a second hip replacement within five years of receiving an ASR implant, the statement from DePuy said, citing new unpublished data from a national registry in Britain. Previously reported follow-up data, including internal company information and clinical trials, had reported lower rates of second hip replacement comparable to similar devices by other companies, the statement said.

But many medical centers in the United States that specialize in joint replacement surgery had already noticed a higher failure rate with the DePuy hip implants, said Dr. Joshua J. Jacobs, the chairman of orthopedic surgery at Rush University Medical Center in Chicago.

“Most major medical centers have seen issues with this device,” Dr. Jacobs said. “This does not come as a surprise.”

Dr. Jacobs added that the DePuy recall pointed to the importance of having a national registry for joint implants that can serve as an early warning system for product problems. Britain, Australia and some other countries have such national registries, he said, but the reporting system currently used by the F.D.A. does not necessarily capture every device failure.

David Floyd, president of DePuy, said in a statement that the recall would be a concern for patients and their family members and for surgeons.

“We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the costs of doctor visits, tests and procedures associated with the recall,” he said.

Johnson & Johnson comprises more than 250 different operating companies in 60 countries. But the recent recalls and F.D.A. warning letters to several units at Johnson & Johnson raise questions about whether there may be companywide problems, industry analysts said.

“No. 1, is there a systemic issue at J.& J.?” said Rick Wise, an analyst at Leerink Swann, a health care investment bank. “No. 2, is this” hip implant recall “reflective of that systemic issue? And, No. 3, is there more to come?”

Mr. Wise added that F.D.A. warnings and J.& J. recalls had come at a time of increased vigilance about product safety by the agency and health care companies. He said that he believed the various problems at J&J were separate and not part of a systemic issue.

Dr. Trombetta, the pharmaceutical marketing professor, compared Johnson & Johnson to Toyota, another multinational firm whose reputation has suffered this year during a series of recalls. The recalls may be tarnishing Johnson & Johnson’s apple-pie image, Dr. Trombetta said, but he predicted that the company would eventually recover public trust as Toyota largely had.

Shares of Johnson & Johnson closed at $57.80 on Thursday, down 18 cents.

[Dispatch]

 

Let's all hope the Digest's article kicked the ball into motion...stay tuned more to come I'm sure.

Take care!

[dennis100]

From article:

"Keeton needed emergency surgery to cut away infected tissue. She spent 16 harrowing days in the hospital and was bed-bound for another three months. Then, after her wound had closed, the mesh began eroding through the wall of her bladder like a grater through cheese. "The pain was so bad that it woke me up even when I was on a morphine drip," says Keeton, who has had 16 surgeries and procedures to repair the damage. Unable to work and facing a mountain of medical bills, she lost her home and was forced to declare bankruptcy. "Nobody should have to go through what I've had to," she says."

Medscape Medical News

FDA: Continuing Safety Concerns With Transvaginal Mesh
Mark Crane
Authors and Disclosures

July 13, 2011 — A dramatic increase in reports of adverse events over the use of surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) is a continuing serious safety concern, the US Food and Drug Administration (FDA) announced today.

Serious complications associated with surgical mesh for POP procedures and stress urinary incontinence (SUI) are "not rare," the FDA said in an alert, noting a reversal from its 2008 alert that said they were. "Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk," the FDA said.

"There are clear risks associated with the transvaginal placement of mesh to treat POP," said William Maisel, MD, MPH, deputy director and chief scientist of the FDA's Center for Devices and Radiological Health, in a news release. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications."

In 2010, at least 100,000 POP repairs used surgical mesh. About 75,000 of these were transvaginal procedures. POP may develop in 30% to 50% of women in their lifetime, with 2% developing symptoms.

An FDA review of adverse events of all urogynecologic surgical mesh products from January 2005 to December 2010 identified 3979 reports of injury, death, and malfunction. Among the reports, 2874 were received in the last 3 years (January 1, 2008, to December 31, 2010), and included 1503 reports associated with POP repairs and 1371 associated with SUI repairs. The number of reports associated with POP repairs increased by more than 5-fold compared with the number of reports received in the previous 3 years (January 1, 2005, to December 31, 2007), according to the FDA.

Between 2008 and 2010, 7 reported deaths were associated with POP repairs. Follow-up investigation revealed that 3 of the deaths were related to the mesh placement procedure (2 bowel perforations, 1 hemorrhage).

POP occurs when the internal structures that support the pelvic organs, such as the bladder, uterus, and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. Women with POP often experience pelvic discomfort; disruption of their sexual, urinary, and defecatory functions; and an overall reduction in their quality of life.

Surgery to repair POP can be performed through the abdomen or transvaginally, using stitches, or with the addition of surgical mesh to reinforce the repair and correct the anatomy.

Erosion of mesh through the vagina is the most common and consistently reported complication, the FDA said. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.

Mesh contraction is a previously unidentified risk. Reports in the literature associate mesh contraction with vaginal shortening, tightening, and pain. Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse, or an inability to engage in sexual intercourse, the FDA noted. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.

An FDA review of scientific literature over the past 15 years suggests that many patients who undergo transvaginal POP repair with mesh are exposed to additional risks compared with patients who undergo POP repair with stitches alone. Although mesh often corrected anatomy, there was no evidence that mesh provided any greater clinical benefit than nonmesh surgeries.

The FDA urges physicians to recognize that POP can be treated successfully without mesh in most cases. They should consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared with transvaginal POP surgery with mesh.

"Input from the clinicians, manufacturers, and other experts will help the FDA better understand the safety and effectiveness of surgical mesh for POP and SUI repair, including any changes that would improve our oversight," Dr. Maisel said.

The FDA cleared the first surgical mesh product specifically for use in SUI in 1996 and for POP in 2002.
The FDA alert does not address the safety and effectiveness of mesh used to treat SUI or mesh implanted abdominally.

An FDA advisory committee meeting is planned for September to discuss this issue.

"It's too soon to tell what effect this will have on surgical practice, but we'll definitely be getting a lot of questions from patients," Matthew Barber, MD, president-elect of the American Urogynecologic Society and vice-chair of clinical research in the Women's Health Institute at the Cleveland Clinic, Ohio, told Medscape Medical News.

"The 5-fold increase in reported adverse events is large but may not necessarily reflect a worse rate of complications," he said. "Since the 2008 FDA alert, more physicians became aware of the problem and were more likely to report than before."

"It's important to remember that we use mesh in pelvic reconstruction in many ways," Dr. Barber said. "Placement of mesh through the vagina is just one of them. The FDA report doesn't comment on SUIs, where the role for mesh is more delineated and the risks are less. So I hope we don't overinterpret this alert. I'm eager to see what the advisory committee in September comes up with, particularly about relooking at the approval process for how some mesh products come to market. We need to see better studies before these products are available commercially."

Adverse events related to surgical mesh should be reported to MedWatch by telephone at 1-800-332-1088, by fax at 1-800-332-1078, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20857.

Mark Crane, BA
Freelance medical writer, Brick, New Jersey

Disclosure: Mark Crane has disclosed no relevant financial relationships.

http://www.medscape.com/viewarticle/746285