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Tucson woman is part of the worldwide recall on Allergan breast implants

Patient has a warning for others
Posted: 1:30 PM, Aug 04, 2019
Updated: 2019-08-05 20:33:18-04
FDA links breast implants to rare cancer, 9 deaths

TUCSON, Ariz. — A major worldwide recall of breast implants has women across the country worried about their health. One Tucson woman wants to get the word out about the dangers.

In 1998 Lia Chester wanted to balance out her body shape so she decided to get breast implants from a doctor in California, and things were good until she got sick. She was diagnosed with fibromyalgia within five years of getting her implants.

Then, six months ago, Lia's health took another dive. Doctors found fluid around her heart and one of her implants. She also says she's tired and her memory is declining.

She also found out that the textured saline implants that she got years ago from McGhan Medical -- who was bought by Allergan -- were under a recall by the U.S. Food Drug and Food Administration . The announcement came down after the FDA discovered 573 cases of a rare lymphoma were linked to the implants worldwide. At least 12 of the people who died had Allergan implants.

"I'm in pain constantly from it. I'm learning a lot about (BII) Breast Implant Illness. Lots of women have fibromyalgia, lupus, MS and other immune diseases. Once those implants come out they are better within six months," Chester said

Chester says she's planning to have her implants removed within the next two weeks. She hasn't been diagnosed with lymphoma, but wants her implants removed and tested for the disease. She also says there are a lot of other women who want their implants removed but can't afford the $4,000 to $15,000 price tag.

"The capsule, everything has to come out. They're finding out there's mold in the capsules. Don't waste time because the only way they they can know for sure is to have it taken out. I want men and women to feel good about who they are and know that what's inside is way more important than what's on the outside," Chester said.

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At this point the FDA is not recommending removal for everyone and says it's best to see your doctor. They also say the risk for lymphoma is six times higher for those with Allergan implants compared to other textured brands sold in the U.S.

KGUN 9 reached out to the company to confirm free replacements for patients, and they replied with this statement:

Allergan has introduced the BIOCELL® Replacement Warranty, which is a new program, following its voluntary recall of unused BIOCELL® textured breast implants. It is available to all patients currently implanted with BIOCELL® textured implants.

It is important to note that U.S. Food & Drug Administration (US FDA) and other international regulatory agencies are recommending not to remove textured implants or other types of breast implants in patients who do not have symptoms of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), due to the low risk of developing BIA-ALCL.

We encourage patients with BIOCELL® textured implants to speak with their plastic surgeon or healthcare professional about options. The decision to get a breast implant revision is a personal decision between patients and their plastic surgeons or healthcare professional and must be decided based on the appropriate discussion of benefits and risks.

For patients in the U.S. who, as a result of the recall announcement on July 24, 2019, choose to replace their BIOCELL® textured devices with smooth devices in consultation with their plastic surgeon, Allergan will provide Allergan smooth device replacements for free. The program will run for 2 years, until July 24, 2021.

As part of this program, Allergan will not provide surgical fee assistance to revision patients. This decision is in-line with the FDA’s and other global regulatory authorities’ recommendation not to remove textured implants or other types of breast implants in patients who have no symptoms of BIA-ALCL due to the low risk of developing BIA-ALCL.

U.S. Patients who decide to keep their BIOCELL® textured devices will continue to be covered under the NATRELLE® ConfidencePlus® warranty.

The BIOCELL® Replacement Warranty covers all BIOCELL® saline and silicone gel-filled textured implants that may have been originally manufactured under the brands McGHAN, INAMED, or ALLERGAN Natrelle®.

For more information on the recall and warranties, in the U.S., contact Allergan Medical Information at 1-800-678-1605 option #2, or email IR-Medcom@allergan.com.

FDA INFORMATIONAL PAGES
MEDWATCH: To report the problems you've experienced with breast implants to the FDA
FDA request Allergan voluntarily recall certain breast implants and tissue expanders