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textured breast implants

Textured Breast Implants Linked to Lymphoma

Since 2011 reports have surfaced from around the globe regarding a link between textured breast implants and an increased risk of developing a non-Hodgkin’s lymphoma (cancer of the immune system) called BIA-ALCL which grows in the scar tissue surrounding the breast implant.

While the FDA reported the risk of BIA-ALCL among patients with textured implants being  between 1 in 3,817 and 1 in 30,000, more recent data from Australia estimates the risk is as high as 1 in 1,000.

Although it is a highly treatable form of lymphoma, BIA-ALCL can be difficult to diagnose because it is a rare form of cancer whose symptoms mimic other breast problems. The FDA has received reports of 457 cases of BIA-ALCL including nine deaths since September 2018. It is important to note that the data indicate that BIA-ALCL is contracted when textured breast implants, not smooth-surface implants are used. Roughly 12 percent of U.S. women with breast implants have textured implants.

Defects
The rough surface of textured implants allow them to stick to the surrounding tissue and therefore are less likely to move within the implant pocket. Researchers theorize that the surface area of textured implants can lead to BIA-ACLC because it may irritate breast tissue, the patient may be allergic to the implant or be reactive to bacterial that grow on textured  implants.

Patient Symptoms of BIA-ALCL
Symptoms may appear between one and ten years after implantation.

The FDA issued warning letters to Mentor Worldwide LLC on its MemoryShape implant and Sientra, Inc.on its Silicone Gel Breast Implants for failure to perform proper safety studies. Both warning letters cited poor follow up rates.

While no textured breast implants have been banned in the United States, many have been banned in France:

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Medical Device Watch is sponsored by Keefe Law Firm. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.

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