Anyone had to deal with the band system in a leagal way?

[Rachel412 116]

I was just reading information about the recall, and it was from October, but it looks like at the time they said there had been no incidents of bands needing to be removed because of the tube sheath recall. And I went to the direct link on their website but it's gone and searching for recall gets me nowhere. Hmm.

Have you talked to the company directly? In your case I would certainly be looking into pursuing legal action. They KNOW there's a problem, they've made media statements, it's ridiculous that they wouldn't pay to give you a new band. I will say though... I can't imagine them agreeing to pay for you to get a LapBand. If they paid, they'd probably only give you another Realize.

(This is the recall that the OP is referring to, for anyone interested- I highlighted in red)

Post Date: 10/20/10 7:08 pm

VOLUNTARY RECALL OF REALIZE® ADJUSTABLE GASTRIC BAND

CINCINNATI - October 13, 2010 - Obtech Medical Sàrl, a medical device manufacturer, and Ethicon Endo-Surgery (EES), in cooperation with the U.S. food and Drug Administration (FDA), have initiated a voluntary worldwide recall of existing inventory of adjustable gastric band systems sold under the brand name: REALIZE® Adjustable Gastric Bands. There is no action required for patients who already have received these gastric bands, and removal (explantation) of the gastric band is not required.

The voluntary recall was undertaken due to reports of the potential for the Tubing Strain Relief, a small (2 centimeter) flexible sheath on the band's Injection Port, to slide out of its intended position. In these rare cases, the Tubing Strain Relief may slide along the catheter tubing that connects to the Injection Port. If this happens, the Tubing Strain Relief can no longer aid in preventing kinking where the tubing connects to the port. The Tubing Strain Relief was an enhancement made to the gastric band system to address tube kinking, a complication common to all gastric bands.

Movement of the Tubing Strain Relief is highly unlikely to cause any serious injury or adverse health consequences and it rarely affects the band's function. In the extremely rare instance when tube kinking occurs at the Injection Port, the physician might be unable to adjust Fluid volume within the gastric band, which may require additional surgery to correct. The reported incidence of the Tubing Strain Relief sliding out of its intended position is less than 1 in 1,000. The reported incidence of tube kinking at the port related to the Tubing Strain Relief sliding out of position is 1 in 10,000. There have been no reported cases of gastric band removal due to the Tubing Strain Relief sliding out of position.

As part of our ongoing commitment to improve the safety and effectiveness of the band, EES identified this issue as part of the company's continuous improvement program and developed an enhanced design of the component that was approved by the FDA. Hospitals and clinics will receive the enhanced replacement product upon returning the recalled product. All new orders will receive the updated product.

About the Realize® Adjustable Gastric Band

The Realize® Adjustable Gastric Band is used in one type of weight-loss surgery. It contains two main components: the first is a fluid-filled balloon that is placed around the stomach; the second is an injection port to adjust the degree of Fluid in the band. Thin flexible tubing connects these two main components. The recall involves an ancillary component called the Tubing Strain Relief.

If surgeons or patients have any additional questions, they may call our Customer Support Center at 1-866-REALIZE (1-866-732-5493) for more information.

About Ethicon Endo-Surgery

Ethicon Endo-Surgery develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information can be found at www.ethiconendosurgery

[mauraclegg 29]

You were the one who said you were looking for a legal remedy- my point is try calling Realize, writing letters and providing proof of why u are looking for replacement before u jump to a lawsuit especially if u are in that much pain. Lawsuits take years,especially against large companies

[myrann 0]

You were the one who said you were looking for a legal remedy- my point is try calling Realize, writing letters and providing proof of why u are looking for replacement before u jump to a lawsuit especially if u are in that much pain. Lawsuits take years,especially against large companies

I have tried. How do you think I know about them saying they wont pay!

[Melissannde 41]

You might consider contacting Obesitylaw.com. They usually help with insurance denials of covering WLS, but they might have information or suggestions on how to proceed in your situation.

Best of luck to you in getting some satisfaction.

[LargeMediumSmall 3]

I'm not big on law suits either but you are absolutely correct in expecting them to pay for corrective surgery if their product was defective and recalled. I've read other posts of people who had difficulty getting manufacturers to own up to their defective products.

Frankly, if you have to go through surgery AGAIN because of their defective product I think they owe you compensation.

I hope you find the answers you are looking for and feel absolutely terrible about some of those posts people wrote.

Best of luck.

[myrann 0]

I'm not big on law suits either but you are absolutely correct in expecting them to pay for corrective surgery if their product was defective and recalled. I've read other posts of people who had difficulty getting manufacturers to own up to their defective products.

Frankly, if you have to go through surgery AGAIN because of their defective product I think they owe you compensation.

I hope you find the answers you are looking for and feel absolutely terrible about some of those posts people wrote.

Best of luck.

thanks so much