Biocell breast implants textured under scrutiny as women complain of pain



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For Katherine Smylie, it was a five-year journey to discover hair loss, memory nebulisity, irritable bowel syndrome and constant pain – especially migraines.

"I had migraines every day for over two and a half years," said the Edmonton woman.

Her doctors told Smylie that she was crazy, she said, and there was nothing she could do. There were days when she wanted to give up, until she found a rheumatologist who put together all the symptoms and told her one thing: remove her breast implants.

"I felt like I had been validated for the first time: Finally someone was listening to me and was caring about my best interests," Smylie said.

The 47-year-old believes the cause of her health problems was the Biocell texture implants she received in 2012, two years after undergoing a double mastectomy, followed by chemotherapy and radiation therapy.

These same silicone implants, manufactured by Allergan, are being examined with increasing attention by some doctors who say they are seeing many of their patients return with debilitating side effects.

While all textured implants form fluids around them in the body, none is for the extension of the Biocell implant, doctors say, which they believe is because of aggressive texturing that promotes grip and holds the implant more firmly in position.

Katherine Smylie, who had her Biocell textured breast implants removed after experiencing pain, is shown at her home in Edmonton. (Rod Maldaner / CBC)

Breast implants, particularly textured ones, have been associated with a rare form of cancer known as BIA-ALCL, although a very small number of cases have reported Both Canada and the US (Health Canada reports that the rate of occurrence of BIA-ALCL per textured implant sold in Canada is one in 24,177, or 0.0041 percent).

AND While some women believe that breast implants cause other diseases, such as fatigue, muscle weakness, aches and brains, Health Canada said there is no scientific evidence that they are associated with these conditions.

The federal agency issued a moratorium on the use of silicone breast implants in 1992 due to concerns that ruptured implants could cause autoimmune and connective tissue diseases, but further research has found no evidence of this.

A new generation of silicone implants was returned to the market in 2006, and medical experts continued to study the devices, including Biocell textured implants.

Recent studies examine textured implants

The most recent study, written by Vancouver-based plastic surgeon Dr. Vancouver, looked at 539 implants he had removed from patients.

Your discoveries published last September in the journal Plastic and Reconstructive Surgery, said that of all the different types he explored, Biocell texture implants had the shortest shelf life.

"Biocell implants appeared earlier than other types of implants we observed," he said. "So, earlier than saline implants, earlier than flat gel implants."

In a study published last September, Vancouver-based plastic surgeon Dr. Nicholas Carr analyzed 539 implants he had removed from patients in order to track device life. (Nicolas Amaya / CBC)

Textured implants appeared after an average of four years of implantation, Carr said, while saline implants lasted longer at age seven.

According to Carr, 25% of their patients had the same reason for wanting to remove the implants: they were painful.

"I had a hockey player who thought she simply could not play hockey because it was very uncomfortable," he said.

Textured implants were a popular choice for physicians between 2005 and 2012 when Carr says that up to 3,000 procedures were done annually in Canada – both for cosmetic reasons as well as post-mastectomy reconstruction.

They have been seen as a way to reduce capsular contracture, a tightening of the scar tissue that forms around the incision after the implant is placed. The texturing also acts as a kind of velcro, preventing the implant from slipping into the chest wall.

Biocell implants became available in Canada in 2006. It did not take long for some doctors to say they began to notice inflammatory problems around the implants, including pain and swelling.

Dr. Elizabeth Hall-Findlay was one of the first doctors to sound the alarm about Biocell implants, publishing a study in 2011 on the number of patients who had formed double capsules after surgery. (Justin Pennell / CBC)

Dr. Elizabeth Hall-Findlay was one of the first doctors to sound the alarm, publishing a study in 2011 analyzing the number of patients who had formed "double capsules" or two distinct layers of scar tissue around the implant.

By then, the Banff plastic surgeon had performed surgeries using Biocell implants in up to 100 of his patients. Soon after she started tracking the results, she stopped using them.

"I began to see some of my own patients and patients from other plastic surgeons who had swelling, had fluid buildup and had what appeared to be double capsule formation. Instead of a single capsule, there was one around the implant and one attached to the patient, "she said.

Hall-Findlay said his findings were supported by other plastic surgeons who were seeing the same problems. But she was also criticized by five colleagues, three of whom were consultants to Allergan and two of them were company employees.

"In our diary, there was a letter to the editor of three plastic surgeons, all of whom were on Allergan's payroll, which implied that I was not doing the surgery properly."

The lack of reports of adverse events makes it difficult to monitor

This kind of blowback is one thing. But doctors like Hall-Findlay and Carr also say it's hard to keep up with the problem because there is a lack of transparency between Health Canada and the companies that manufacture implants and medical devices.

Any report of an adverse event is made primarily by the industry to Health Canada, but the answers go directly to the company. Surgeons and hospitals are not legally required to report any complications or injuries, although they may decide to do so for ethical reasons.

"We do not receive reports from Health Canada, we do not receive industry reports on what our colleagues are discovering. The only way we can find out is by communicating directly with our colleagues," Carr said.

Both Allergan and Health Canada provided written responses to the CBC on the safety of Biocell textured implants.

Allergan said that "the safety profile of Allergan breast implants is supported by extensive pre-clinical device testing, over a decade of clinical use worldwide, as well as a large number of peer-reviewed and published studies." The company also said it provides patient information leaflets and fully supports informed consent.

Breast implants have a smooth or textured surface. For textured implants, two of which are shown to the right, the gravel acts as a kind of velcro, preventing the implant from slipping into the chest wall. (Nicolas Amaya / CBC)

Health Canada said it "considers reporting of incidents with medical devices, including those for breast implants, as an important part of our post-marketing surveillance activities."

But the federal agency resisted requests for a central registry, saying the records "do not necessarily provide useful information on safety and efficacy … due in part to the bias in the group of patients who are generally willing to participate."

Biocell textured implants have fallen in popularity among many plastic surgeons. Although there are no firm numbers available, based on his research, Carr estimates that about 20% of patients had their implants removed.

Due to the lack of available data, the experiences of the other 80% remain a big question mark. But Carr and Hall-Findlay warn that removal of the implant is not always necessary.

"I do not think that [women] really have to remove them if everything is going well. They just need to know that if they get bloated, or have problems with their breast implants, look for a plastic surgeon and get them checked out, "Hall-Findlay said.

As for Smylie, she says removing her implants was as difficult as getting the diagnosis; her doctors were reluctant and only offered a partial procedure that she feared left leftover implants in her body.

She finally found a Florida specialist who agreed to remove them completely last month. The relief was almost immediate, Smylie said.

"It was a sigh of relief to wake up and not have a migraine for the first time in two and a half years.

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