A major producer of breast implants is stopping the sale and distribution of its textured implants amid growing links to a rare and deadly cancer. Thefrom Allergan after a "significant increase" in cases of a particular type of lymphoma.
have been pushing the FDA to pay attention for some time. But even though textured implants have been taken off the shelves in other countries, the U.S. is only now getting up to speed.
"Had we known of a risk, yeah, we would have never opted to have an implant," said Lory Daddario. Daddario had already beaten breast cancer once — but in 2017, two years after getting textured implants from a different manufacturer following reconstructive surgery, she says her right breast suddenly grew to three times its normal size.
"The swelling was so rapid and so pronounced that I knew, I just knew that it wasn't normal," she said.
Daddario underwent a battery of tests, and found out that cancer had developed around her breast implants.
"That was total shock," she said. "Even now, sometimes I go, 'How can that be?'"
Dadarrio's implants were manufactured by the company Mentor. She is one of a growing number of women being diagnosed with the rare disease known as Breast Implant-Associated Anaplastic Large Cell Lymphoma, associated with the textured form of implants.
The FDA says the risk of lymphoma with Allergan's Biocell textured implants, the implants that have been recalled, is approximately six times that of other manufacturers who are selling in the U.S.
The FDA has linked Allergan's implants to "significant patient harm, including death." The FDA said that of 573 such lymphoma cases, 481 are "attributed to Allergan implants" — and at least 12 of the 33 patients who've died had the company's implants. Allergan told CBS News that it's voluntarily recalling its Biocell textured implants and tissue expanders worldwide as a "precaution."
One theory about the disease, according to Texas breast surgeon Dr. Elisabeth Potter, is that the textured surface irritates and inflames the tissue. As early as this March, Potter refused to use textured implants in her patients.
"I often say this doesn't pass the 'sister test'," she said, explaining that if she wouldn't give it to her sister, she won't give it to her patients.
Daddario, now 58, is cancer-free. But she says the recall doesn't go far enough. "One person with this lymphoma is one too many," she said.
The FDA is not recommending that women without symptoms remove the implants because of the risks of surgery. Doctors say that women who have the implants should be on the lookout for symptoms like unexplained pain and swelling, and should visit their doctor if they have any concerns. But Dr. Potter said that many patients want them out — and that's she's personally removed them for 35 women.
Mentor stands by its textured implants and says the cancer is "rare" with its product.
Read Mentor's full statement below:
"Nothing is more important to Mentor than the health and safety of the women who choose our breast implants. Selection of the most appropriate implant for a patient should be based on conversations between the patient and the doctor, including the associated benefits and risks, as part of a thorough informed consent process.
The safety and clinical performance of MENTOR® Breast Implants is supported by long-term clinical data, including three, 10-year, prospective clinical trials. Current literature and real world evidence concludes that the risk of developing BIA-ALCL varies between different textured devices and has been shown to be rare with MENTOR® Breast Implants.
The FDA's analysis of newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL provides the latest information on the agency's findings.
While a low number of BIA-ALCL cases have been reported in patients with MENTOR® Breast Implants, it remains a concern we take seriously. We closely monitor reports of BIA-ALCL through international registries and post-market surveillance activities and continue to work with industry groups, physicians, scientists and health authorities to deepen our understanding of the associated risks and causes of this rare type of lymphoma.
We believe MENTOR® textured implants are an important option for women who are considering breast reconstruction following mastectomy or for those considering augmentation. Our microtextured implants have certain advantages over smooth implants such as reductions in implant rotation and capsular contracture."